Multimedia Admission Orientation in NICU
Primary Purpose
Stress, Psychological, Preterm Infants, Intensive Care Units, Neonatal
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
a multimedia admission orientation
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Psychological focused on measuring Neonatal Intensive Care Unit, Admission Orientation, Multimedia Education, Parental, Parental Uncertainty, Quasi-Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria of the Primary Caregiver
- 1. Able to listen, speak, write and read Chinese, report of no psychological problems, and agree to give consent and fill out questionnaires of the study.
- 3. The potential caregiver whose infant born within one month and needs to be admitted to the intensive care unit for the first time due to an acute and severe illness
- 4. For those whose infant needs to use the ventilator in admission.
Exclusion Criteria:
- 1.Have a history of mental disorders including depression, cognitive impairment, addiction to smoking or drinking.
- 2. The primary caregiver who is the care assistant/carer/nanny of the infant who admitted to the NICU.
- 3. For those potential caregiver whose infant has congenital abnormality identified by the physician.
Sites / Locations
- Cathay General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
multimedia admission orientation
Arm Description
Multimedia admission orientation for the parents of infants admitted to NICU is provided to the experimental group of the parents. The multimedia orientation based on animation and graphic figures to explain the basic information about the NICU environment and precautions and the essential tests and examination taken for their infant during the initial stage of NICU admission.
Outcomes
Primary Outcome Measures
parental stress
Questionnaire measurement: The Parenting Stress Index-Short Form (PSI-SF) administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 36 items. Higher scores mean worse outcome.
parental uncertainty
Questionnaire measurement: Parents' Perception of Uncertainty Scale (PPUS) modified from Mishel Uncertainty in Illness Scale (MUIS) as developed by Mishel, administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 30 items. Higher scores mean worse outcome.
knowledge of admission
self-developed questionnaire of a knowledge test regarding NICU admission, a 5-point Likert scale (highly agree to highly disagree), a total of 17 items. Higher scores mean better outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT05214248
First Posted
August 30, 2021
Last Updated
January 17, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cathay General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05214248
Brief Title
Multimedia Admission Orientation in NICU
Official Title
The Effect of a Multimedia Admission Orientation on the Parental Stress, Uncertainty, and Knowledge of Unit-admission in Primary Caregivers of High-risk Infants in a Neonatal Intensive Care Unit: a Quasi-randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cathay General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The effect of a multimedia admission orientation on the parental stress, uncertainty, and knowledge of primary caregivers of high-risk infants in a neonatal intensive care unit: a quasi-randomized controlled trial study.
Detailed Description
Neonatal Intensive Care Unit (NICU) is the place of caring for high-risk newborns whose primary caregivers would be very stressful due to unfamiliar medical equipment and environment. Furthermore, those primary caregivers of critically ill infants hospitalized in NICU may be even more distress as result of the constraint in visiting time and measures of insolation. Most studies have indicated that those primary caregivers of infants in NICU can experience a high level of parental stress particularly during the initial phase of admission. The literature has reported that during the admission the infant's conditions are prone to be unstable to an extent that can threaten his or her life which can result in the feeling of helplessness, uncertainty, low self-esteem and loss of control in those parents.
The study aims to use a pre- and post-test quasi-randomized controlled trail to examine the effect of Multimedia Orientation Animation of NICU Admission for parents of critically ill infants. The video contain an introduction of common diseases seen in infants in NICU such as respiratory distress and the common medical equipment used and NICU environment. The major purpose of the educational video is to help the primary caregivers understand important information about the newborn's admission to the NICU. The data collection site of the study is one of the NICU from the north medical center in Taiwan. The subjects are grouped by time intervals, and divided into control and experimental groups, and that survey will be collected first with control group who will be provided with regular nursing care in term of admission orientation, and the experiment group is approached after the cessation of data collection from control group, which Multimedia Admission Orientation are offered to the experiment group. The measurements of the study include the caregivers' parental stress, the level of uncertainty and knowledge of admission after being treated by our intervention. The IRB of this study (IRB no.CGH-P110036) has been granted by Cathay General Hospital in Taipei, R.O.C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Preterm Infants, Intensive Care Units, Neonatal, Education
Keywords
Neonatal Intensive Care Unit, Admission Orientation, Multimedia Education, Parental, Parental Uncertainty, Quasi-Randomized Controlled Trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multimedia admission orientation
Arm Type
Experimental
Arm Description
Multimedia admission orientation for the parents of infants admitted to NICU is provided to the experimental group of the parents. The multimedia orientation based on animation and graphic figures to explain the basic information about the NICU environment and precautions and the essential tests and examination taken for their infant during the initial stage of NICU admission.
Intervention Type
Other
Intervention Name(s)
a multimedia admission orientation
Intervention Description
A short video based on self-drawing characters and figures with Chinese dubbing and background light music, explaining the NICU environment, health care workers, and tests and examination that are essential for an infant admitted to this NICU of Cathay Hospital in Taipei, R.O.C.
Primary Outcome Measure Information:
Title
parental stress
Description
Questionnaire measurement: The Parenting Stress Index-Short Form (PSI-SF) administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 36 items. Higher scores mean worse outcome.
Time Frame
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
Title
parental uncertainty
Description
Questionnaire measurement: Parents' Perception of Uncertainty Scale (PPUS) modified from Mishel Uncertainty in Illness Scale (MUIS) as developed by Mishel, administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 30 items. Higher scores mean worse outcome.
Time Frame
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
Title
knowledge of admission
Description
self-developed questionnaire of a knowledge test regarding NICU admission, a 5-point Likert scale (highly agree to highly disagree), a total of 17 items. Higher scores mean better outcome.
Time Frame
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria of the Primary Caregiver
1. Able to listen, speak, write and read Chinese, report of no psychological problems, and agree to give consent and fill out questionnaires of the study.
3. The potential caregiver whose infant born within one month and needs to be admitted to the intensive care unit for the first time due to an acute and severe illness
4. For those whose infant needs to use the ventilator in admission.
Exclusion Criteria:
1.Have a history of mental disorders including depression, cognitive impairment, addiction to smoking or drinking.
2. The primary caregiver who is the care assistant/carer/nanny of the infant who admitted to the NICU.
3. For those potential caregiver whose infant has congenital abnormality identified by the physician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai-Wei K. Wang, Ph.D.
Phone
886228227101
Ext
3150
Email
kaiwei@ntunhs.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Fu-Ching Hsu, BSN
Phone
886983755082
Email
fuching19930816@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Wei K. Wang, Ph.D.
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Wei K. Wang, Ph.D.
Phone
886228227101
Ext
3150
Email
kaiwei@ntunhs.edu.tw
First Name & Middle Initial & Last Name & Degree
Fu-Ching Hsu, BSN
Phone
886983755082
Email
fuching19930816@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1097/JNR.0000000000000134
Available IPD/Information Comments
Article title: The Lived Experience of Jordanian Parents in a Neonatal Intensive Care Unit: A Phenomenological Study
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1017/S1463423619000021
Available IPD/Information Comments
Article Title: Stress and feelings in mothers and fathers in NICU: identifying risk factors for early interventions
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.3389/fped.2019.00439
Available IPD/Information Comments
Article title: Parental Stress Experience and Age of Mothers and Fathers After Preterm Birth and Admission of Their Neonate to Neonatal Intensive Care Unit; A Prospective Observational Pilot Study
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.4040/jkan.2012.42.7.936
Available IPD/Information Comments
Article Title: Development and Evaluation of a Video Discharge Education Program focusing on Mother-infant Interaction for Mothers of Premature Infants
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1542/pir.35.10.417
Available IPD/Information Comments
Article Title: Respiratory Distress in the Newborn
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1016/j.jnn.2017.04.001
Available IPD/Information Comments
Article Title: A fathers' group in NICU: Recognising and responding to paternal stress, utilising peer support
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1016/S0377-1237(10)80131-5
Available IPD/Information Comments
Article Title: Meconium Aspiration Syndrome: An Insight
Learn more about this trial
Multimedia Admission Orientation in NICU
We'll reach out to this number within 24 hrs