Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
Primary Purpose
Preterm Infants, Sleep, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Early Sleep Facilitation Program
Routine care
Sponsored by
About this trial
This is an interventional health services research trial for Preterm Infants focused on measuring Preterm Infants, Sleep, Quality of Life, Attachment, Actigraphy
Eligibility Criteria
Inclusion Criteria:
- Preterm infants gestational age (GA) > 28 weeks and < 37 weeks, and birth weight less than 2200 grams;
- The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
- The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form
Exclusion Criteria:
- Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
- Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
- Those who need to take muscle relaxants, sedatives or bronchodilators
Sites / Locations
- National defense medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Sleep Facilitation Program
routine care and provide general discharge care and nursing guidance
Arm Description
Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge
Routine care and provide general discharge care and nursing guidance.
Outcomes
Primary Outcome Measures
Preterm Infants' Sleep- Actigraphy -T1
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T2
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T3
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T4
Accessed by Actigraphy
Preterm Infants' Sleep- sleep log -T1
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T2
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T3
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T4
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Health- Health Assessment Form-weight-T1
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T2
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T3
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T4
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T1
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T2
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T3
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T4
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Nutrition data-T1
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T2
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T3
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T4
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Caregivers' Sleep- Actigraphy-T1
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T2
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T3
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T4
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Sleep log-T1
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T2
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T3
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T4
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Stress- T1
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T2
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T3
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T4
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' quality of life-T1
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T2
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T3
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T4
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' attachment-T1
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T2
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T3
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T4
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Secondary Outcome Measures
Full Information
NCT ID
NCT04932044
First Posted
May 28, 2021
Last Updated
June 12, 2021
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04932044
Brief Title
Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
Official Title
Construction and Longitudinal Following Up the Effects of Early Sleep Facilitation Program on Preterm Infants' Sleep, Health After Discharge, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Detailed Description
Background and purpose:
Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but the sleep of preterm infants is disturbed by the environment of the intensive care unit, invasive treatment and care activities. When a preterm infant's sleep is interrupted, it not only affects his physical growth, behavior and emotional development, but also affects his recovery from illness and the length of hospital stay, and even affects his sleep quality and development after returning home. However, medical personnel are busy with clinical practice, seldom pay attention to the sleep development of preterm infants. In the past, few studies paid attention to the factors that affect the sleep of preterm infants after returning home, and few studies also explored the sleep and physical and mental health of preterm infants and their main caregivers after returning home. Sleep intervention in preterm infants was mostly a single outcome indicator; besides, past studies lacked objective sleep instruments and long-term follow-up studies.
Based on the above research gaps, this research plan to construct an "early sleep Facilitation program" and to explore the effects of the "Early Sleep Facilitation Program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Methods:
This randomized controlled trial will adopt a longitudinal repeated measures design to examine the " Early Sleep Facilitation Program " on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver. Preterm infants and the caregiver were recruited by convenience sampling in Neonatal Intensive Care Unit and Infant Intermediate Care Unit of a medical center in northern Taiwan from July in 2020 to December in 2022. There are two different intervention modes (intervention group and control group), the intervention group receives " Early Sleep Facilitation Program " and the control group receives routine care. The program is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status after the first month and the second month after discharge. The control group receives routine care and provide general discharge care and nursing guidance. The questionnaires and physiological measurements will be used to collect the data. The two groups will collect data during hospitalization, one week before discharge, and the first month and the second month after discharge. We will use generalized estimation equations method to analyze research data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Sleep, Quality of Life
Keywords
Preterm Infants, Sleep, Quality of Life, Attachment, Actigraphy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Sleep Facilitation Program
Arm Type
Experimental
Arm Description
Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge
Arm Title
routine care and provide general discharge care and nursing guidance
Arm Type
Active Comparator
Arm Description
Routine care and provide general discharge care and nursing guidance.
Intervention Type
Behavioral
Intervention Name(s)
Early Sleep Facilitation Program
Intervention Description
It is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status within two months after discharge.
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Receives routine care and provide general discharge care and nursing guidance.
Primary Outcome Measure Information:
Title
Preterm Infants' Sleep- Actigraphy -T1
Description
Accessed by Actigraphy
Time Frame
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Title
Preterm Infants' Sleep- Actigraphy -T2
Description
Accessed by Actigraphy
Time Frame
T2- preterm infants one week before discharge
Title
Preterm Infants' Sleep- Actigraphy -T3
Description
Accessed by Actigraphy
Time Frame
T3- preterm infants the first month after discharge
Title
Preterm Infants' Sleep- Actigraphy -T4
Description
Accessed by Actigraphy
Time Frame
T4- preterm infants second month after discharge
Title
Preterm Infants' Sleep- sleep log -T1
Description
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Time Frame
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Title
Preterm Infants' Sleep- sleep log -T2
Description
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Time Frame
T2- preterm infants one week before discharge
Title
Preterm Infants' Sleep- sleep log -T3
Description
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Time Frame
T3- preterm infants the first month after discharge
Title
Preterm Infants' Sleep- sleep log -T4
Description
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Time Frame
T4- preterm infants second month after discharge
Title
Preterm Infants' Health- Health Assessment Form-weight-T1
Description
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Title
Preterm Infants' Health- Health Assessment Form-weight-T2
Description
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T2- preterm infants one week before discharge
Title
Preterm Infants' Health- Health Assessment Form-weight-T3
Description
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T3- preterm infants the first month after discharge
Title
Preterm Infants' Health- Health Assessment Form-weight-T4
Description
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T4- preterm infants second month after discharge
Title
Preterm Infants' Health- Health Assessment Form- head circumference-T1
Description
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Title
Preterm Infants' Health- Health Assessment Form- head circumference-T2
Description
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T2- preterm infants one week before discharge
Title
Preterm Infants' Health- Health Assessment Form- head circumference-T3
Description
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T3- preterm infants the first month after discharge
Title
Preterm Infants' Health- Health Assessment Form- head circumference-T4
Description
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Time Frame
T4- preterm infants second month after discharge
Title
Preterm Infants' Health- Nutrition data-T1
Description
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Time Frame
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Title
Preterm Infants' Health- Nutrition data-T2
Description
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Time Frame
T2- preterm infants one week before discharge
Title
Preterm Infants' Health- Nutrition data-T3
Description
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Time Frame
T3- preterm infants the first month after discharge
Title
Preterm Infants' Health- Nutrition data-T4
Description
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' Sleep- Actigraphy-T1
Description
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' Sleep- Actigraphy-T2
Description
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' Sleep- Actigraphy-T3
Description
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' Sleep- Actigraphy-T4
Description
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' Sleep- Sleep log-T1
Description
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' Sleep- Sleep log-T2
Description
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' Sleep- Sleep log-T3
Description
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' Sleep- Sleep log-T4
Description
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' Stress- T1
Description
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' Stress- T2
Description
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' Stress- T3
Description
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' Stress- T4
Description
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' quality of life-T1
Description
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' quality of life-T2
Description
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' quality of life-T3
Description
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' quality of life-T4
Description
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Time Frame
T4- preterm infants second month after discharge
Title
Caregivers' attachment-T1
Description
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Time Frame
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Title
Caregivers' attachment-T2
Description
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Time Frame
T2- preterm infants one week before discharge
Title
Caregivers' attachment-T3
Description
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Time Frame
T3- preterm infants the first month after discharge
Title
Caregivers' attachment-T4
Description
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Time Frame
T4- preterm infants second month after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Preterm infants gestational age (GA) > 28 weeks and < 37 weeks, and birth weight less than 2200 grams;
The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form
Exclusion Criteria:
Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
Those who need to take muscle relaxants, sedatives or bronchodilators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiang-Yun Lan, Asst. Prof.
Phone
87923311
Ext
18781
Email
shinnylan@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiang-Yun Lan, Asst. Prof.
Organizational Affiliation
National Defense Medical Center, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National defense medical center
City
Taipei city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang-Yun Lan, Asst. Prof.
Phone
87923100
Ext
18781
Email
shinnylan@msn.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
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