Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06525142

The Effectiveness of Audiovisual Intervention

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Parent-Child Relations Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infant Disease Premature; Infant, Light-for-dates Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audiovisual Intervention

Behavioral

【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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Chun Lin

CONTACT

[email protected]

02-27135211 ext. 3356

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.