The Effectiveness of Audiovisual Intervention

July 23, 2024 updated by: Li Yi-Chun, Chang Gung Memorial Hospital

The Effectiveness of Audiovisual Intervention on the Parent-Child Bonding, Parental Role Perception, and Well-Being in Fathers of Premature Infants

The objective of this clinical study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants. The main questions it aims to answer are:

  • After intervention, whether the parent-child connection between fathers and preterm infants in the audio-visual group is higher than that in the audio-visual group and the control group
  • After the intervention, whether the father's perception of parenting role in the audio-visual group is higher than that of the vocal group and the control group
  • After intervention, whether the father's happiness in the audio-visual group is higher than that in the audio-visual group and the control group The investigators will compare the pre- and post-test methods bwtween the experimental groups and the control group. The fathers of enrolled preterm infants will fill in the structured questionnaires at the time before the intervention (Baseline data) and one month later after the intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial, which will compare the pre- and post-test methods between the experimental groups (2 groups) and the control group in an attempt to explore the effect of audio-visual intervention on the parent-child bond, parent-role perception and well-being of fathers of preterm infants.

The total number of participants is estimated as 99. All fathers of preterm infants will complete three questionnaires at the time of 1-3 days , one week, and one month of age of their preterm babies). It will take about 10-20 minutes for questionnaire survey each time. Study participants were randomly assigned to the following three groups (33 in each group):

【Group 1】During the first three days, the researchers will provide a storybook to the father of the premature infant, and the researchers assist in recording the father's voice of the storybook in the form of MP4 recording. At the fourth day, one hour after the baby feeding, the father's voice will be played by the player to the baby, for 2 consecutive days, 2 times/day, 10 minutes/time. The baby's heartbeat, breathing and blood oxygen changes will be recorded and monitored with a physiological monitor. The recording files will be kept by the researcher.

【Group 2】 The intervention will be the same with Group 1 except the following intervention: on the 4th-6th day of the baby's birth, sleeping in the incubator, the baby's reaction behavior will be taken with a mobile phone, 1 time/day, 5 minutes/time, for 3 consecutive days, the image feedback is delivered to the father in person.

【Group 3】This group is a control group. The fathers and preterm infants will not receive interventions conducted in group 1 and 2.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • father age > 20
  • premature infant born at 29-36 weeks

Exclusion Criteria:

  • infant failing the hearing examination
  • father and mother are not married

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Effectiveness of Audiovisual Intervention
The study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants
Behavioral: Audiovisual Intervention

【Group 1】During the first three days, the researchers will provide a storybook to the father of the premature infant, and the researchers assist in recording the father's voice of the storybook in the form of MP4 recording. At the fourth day, one hour after the baby feeding, the father's voice will be played by the player to the baby, for 2 consecutive days, 2 times/day, 10 minutes/time. The baby's heartbeat, breathing and blood oxygen changes will be recorded and monitored with a physiological monitor. The recording files will be kept by the researcher.

【Group 2】 The intervention will be the same with Group 1 except the following intervention: on the 4th-6th day of the baby's birth, sleeping in the incubator, the baby's reaction behavior will be taken with a mobile phone, 1 time/day, 5 minutes/time, for 3 consecutive days, the image feedback is delivered to the father in person.
Placebo Comparator: control
The study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants
Behavioral: Audiovisual Intervention

【Group 1】During the first three days, the researchers will provide a storybook to the father of the premature infant, and the researchers assist in recording the father's voice of the storybook in the form of MP4 recording. At the fourth day, one hour after the baby feeding, the father's voice will be played by the player to the baby, for 2 consecutive days, 2 times/day, 10 minutes/time. The baby's heartbeat, breathing and blood oxygen changes will be recorded and monitored with a physiological monitor. The recording files will be kept by the researcher.

【Group 2】 The intervention will be the same with Group 1 except the following intervention: on the 4th-6th day of the baby's birth, sleeping in the incubator, the baby's reaction behavior will be taken with a mobile phone, 1 time/day, 5 minutes/time, for 3 consecutive days, the image feedback is delivered to the father in person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Bonding Questionnaire
Time Frame: one month
This questionnaire was designed by Brockington et al and published in 2001. The scale is a 5-point Likert's score. The higher score means a better parent-child bounding.
one month
Paternal Role Significance Questionnaire
Time Frame: one month
This questionnaire was designed by Bruce et al and published in 1999. The scale is a 4-point Likert's score. The higher score means a better significance of paternal role.
one month
Satisfaction With Life Scale
Time Frame: one month
This questionnaire was designed by Diener et al and published in 1985. The scale is a 7-point Likert's score. The higher score means a better satisfaction with life.
one month
Positive and Negative Affect Schedule (PANAS)
Time Frame: one month
This questionnaire was designed by Diener et al and published in 1995. The scale is a 7-point Likert's score. The higher score means more perceived happiness in life.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hsing-Yi Yu,, Chang Gung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 4, 2026

Study Completion (Estimated)

June 5, 2026

Study Registration Dates

First Submitted

July 7, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Li Yi-Chun

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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