The Effectiveness of Audiovisual Intervention

NCT06525142 | Not Yet Recruiting

• 1 other identifier: Li Yi-Chun
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parent-Child Relations; Premature; Infant, Light-for-dates; Premature Infant Disease

Keywords

Parent-Child Bonding,Parental Role Perception,Well-Being

Outcome Measures

Primary Outcomes (4)

• Postpartum Bonding Questionnaire

  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

  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

  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)

  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

Study Arms (2)

The Effectiveness of Audiovisual Intervention

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Interventions

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.

The Effectiveness of Audiovisual Intervention; control

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (5)

• Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10.

  PMID: 29535067 RESULT

• Rossen L, Hutchinson D, Wilson J, Burns L, A Olsson C, Allsop S, J Elliott E, Jacobs S, Macdonald JA, Mattick RP. Predictors of postnatal mother-infant bonding: the role of antenatal bonding, maternal substance use and mental health. Arch Womens Ment Health. 2016 Aug;19(4):609-22. doi: 10.1007/s00737-016-0602-z. Epub 2016 Feb 11.

  PMID: 26867547 RESULT

• Rowe HJ, Wynter KH, Steele A, Fisher JR, Quinlivan JA. The growth of maternal-fetal emotional attachment in pregnant adolescents: a prospective cohort study. J Pediatr Adolesc Gynecol. 2013 Dec;26(6):327-33. doi: 10.1016/j.jpag.2013.06.009. Epub 2013 Sep 26.

  PMID: 24075091 RESULT

• Sajjadian N, Mohammadzadeh M, Alizadeh Taheri P, Shariat M. Positive effects of low intensity recorded maternal voice on physiologic reactions in premature infants. Infant Behav Dev. 2017 Feb;46:59-66. doi: 10.1016/j.infbeh.2016.11.009. Epub 2016 Nov 30.

  PMID: 27914263 RESULT

• Makela H, Axelin A, Feeley N, Niela-Vilen H. Clinging to closeness: The parental view on developing a close bond with their infants in a NICU. Midwifery. 2018 Jul;62:183-188. doi: 10.1016/j.midw.2018.04.003. Epub 2018 Apr 11.

  PMID: 29684798 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hsing-Yi Yu,

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chun Lin

CONTACT

02-27135211; lin1427@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal intensive care nurse

Model Details: 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 Record Dates

• First Submitted: July 7, 2024
• First Posted: July 29, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share