Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers
Primary Purpose
Attachment, Parental Stress
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Early Parental Sensitivity Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Attachment focused on measuring preterm infant mothers, early, parental sensitivity intervention, attachment, parenting confidence, parental stress
Eligibility Criteria
Inclusion Criteria:
Preterm infants:
- Preterm infants less than 37 weeks gestation and hospitalized in the NICU
- The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
Preterm infant mothers:
- Children have not been hospitalized in the NICU in the past
- At least 20 years old
- They can speak Chinese, Taiwanese fluently and need to be literate
Exclusion Criteria:
Preterm infants :
- Combined congenital diseases and chromosomal abnormalities
- Immediate surgery, first aid and unstable vital signs are necessary after birth
- The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
Preterm infant mothers:
- Hospitalized in the intensive care unit
Sites / Locations
- National Yang Ming Chiao Tung UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Parental Sensitivity Intervention Program
Control group
Arm Description
The protocol will last five to seven days for preterm infant mothers.
The control group received general routine nursing guidance.
Outcomes
Primary Outcome Measures
Maternal Attachment Inventory
Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Maternal Confidence Questionnaire
Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Parental Stressor Scale: Infant Hospitalization
Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.
Secondary Outcome Measures
Maternal Attachment Inventory
Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Maternal Confidence Questionnaire
Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Parental Stressor Scale: Infant Hospitalization
Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.
Full Information
NCT ID
NCT05302700
First Posted
March 15, 2022
Last Updated
March 23, 2023
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT05302700
Brief Title
Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers
Official Title
The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
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
In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.
Detailed Description
The study was a quantitative study of a randomized controlled trial, designed by experimental research method. Using GPower 3.1.2 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size was 80.
The subjects were divided into two groups, The control group received general routine nursing guidance, while the experimental group received general routine nursing guidance and early parental sensitivity intervention program. Using the NICU VR Tour and Premature Infant Behavioral Clues Teaching Materials as educational tools for early parental sensitivity intervention program. The outcome used the Maternal Attachment Inventory, Maternal Confidence Questionnaire and Parental Stressor Scale: Infant Hospitalization as evaluated tools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attachment, Parental Stress
Keywords
preterm infant mothers, early, parental sensitivity intervention, attachment, parenting confidence, parental stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Parental Sensitivity Intervention Program
Arm Type
Experimental
Arm Description
The protocol will last five to seven days for preterm infant mothers.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received general routine nursing guidance.
Intervention Type
Behavioral
Intervention Name(s)
Early Parental Sensitivity Intervention
Intervention Description
Parental sensitivity intervention include (1)Establish an emotional connection:Using the VR tour to introduce the environment, instruments and equipment of the neonatal intensive care unit, appearance of premature infants and pipeline wires on their bodies .(2)maintain physical proximity:proactively provide mothers with the opportunity to touch the body of preterm infants.(3) parents must understand their infant's cues:Using the Premature Infant Behavioral Clues Teaching Materials to play video and we will discuss and respond to the mother's questions.(4)engage in his/her care and communicate appropriately with him/her:We will discuss the behavioral clues of the preterm infant with the mother next to the incubator, encourage the mother to ask questions and participate in care activities such as changing diapers and stamping the baby's footprints on the card, asking the mother to write down the number of days of birth, corrected age, weight and what she wants to say for her baby.
Primary Outcome Measure Information:
Title
Maternal Attachment Inventory
Description
Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Time Frame
On the fifth to seventh day after birth of preterm infant.
Title
Maternal Confidence Questionnaire
Description
Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Time Frame
On the fifth to seventh day after birth of preterm infant.
Title
Parental Stressor Scale: Infant Hospitalization
Description
Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.
Time Frame
On the fifth to seventh day after birth of preterm infant.
Secondary Outcome Measure Information:
Title
Maternal Attachment Inventory
Description
Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Time Frame
The first month of birth of preterm infant.
Title
Maternal Confidence Questionnaire
Description
Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Time Frame
The first month of birth of preterm infant.
Title
Parental Stressor Scale: Infant Hospitalization
Description
Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.
Time Frame
The first month of birth of preterm infant.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants:
Preterm infants less than 37 weeks gestation and hospitalized in the NICU
The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
Preterm infant mothers:
Children have not been hospitalized in the NICU in the past
At least 20 years old
They can speak Chinese, Taiwanese fluently and need to be literate
Exclusion Criteria:
Preterm infants :
Combined congenital diseases and chromosomal abnormalities
Immediate surgery, first aid and unstable vital signs are necessary after birth
The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
Preterm infant mothers:
Hospitalized in the intensive care unit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting-Yi Hsu, MD
Phone
+866919059641
Email
ps810424@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Wen Chen, PhD
Phone
+886- 2-28267348
Email
chiwenchen@nycu.edu.tw
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Wen Chen, PhD
Phone
+886- 2-28267348
Email
chiwenchen@nycu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28335806
Citation
Lavallee A, Aita M, Bourbonnais A, De Clifford-Faugere G. Effectiveness of early interventions for parental sensitivity following preterm birth: a systematic review protocol. Syst Rev. 2017 Mar 23;6(1):62. doi: 10.1186/s13643-017-0459-x.
Results Reference
background
PubMed Identifier
32332447
Citation
Dunham MM, Marin T. NICU Maternal-Infant Bonding: Virtual Visitation as a Bonding Enhancement Tool. J Perinat Neonatal Nurs. 2020 Apr/Jun;34(2):171-177. doi: 10.1097/JPN.0000000000000484.
Results Reference
background
PubMed Identifier
33415290
Citation
Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec.
Results Reference
background
PubMed Identifier
32199458
Citation
Kim AR, Kim SY, Yun JE. Attachment and relationship-based interventions for families during neonatal intensive care hospitalization: a study protocol for a systematic review and meta-analysis. Syst Rev. 2020 Mar 21;9(1):61. doi: 10.1186/s13643-020-01331-8.
Results Reference
background
Learn more about this trial
Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers
We'll reach out to this number within 24 hrs