Parent-Child RelationsNCT06525142
The Effectiveness of Audiovisual Intervention
A study testing Audiovisual Intervention in people with Parent-Child Relations and Premature; Infant, Light-for-dates, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Premature; Infant, Light-for-dates, Premature Infant Disease
- What is being tested?
- Audiovisual Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- father age > 20
- premature infant born at 29-36 weeks
Who cannot join
- infant failing the hearing examination
- father and mother are not married
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Audiovisual Intervention
- Keywords
- Parent-Child Bonding,Parental Role Perception,Well-Being
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual InterventionBehavioural
【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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Audiovisual Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startJul 2024 (estimated)
- Primary completion4 Jun 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yi-Chun, Chang Gung Memorial Hospital
- Investigators
- Hsing-Yi Yu,, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525142
- Sponsor's protocol ID
- Li Yi-Chun
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29535067Rossen 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.
PubMed 26867547Rowe 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.
PubMed 24075091Sajjadian 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.
PubMed 27914263Makela 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.
PubMed 29684798
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Audiovisual Intervention on the Parent-Child Bonding, Parental Role Perception, and Well-Being in Fathers of Premature Infants
- ClinicalTrials.gov ID
- NCT06525142
- Acronym / sponsor ID
- Li Yi-Chun
- Keywords
- Parent-Child Bonding,Parental Role Perception,Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- 4 Jun 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Effectiveness of Audiovisual Intervention | Experimental | Behavioral: Audiovisual InterventionThe 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 |
| control | Placebo comparator | Behavioral: Audiovisual InterventionThe 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 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- father age > 20
- premature infant born at 29-36 weeks
Key exclusion criteria (2 listed)
- infant failing the hearing examination
- father and mother are not married
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | The Effectiveness of Audiovisual Intervention, control |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Results publication: PubMed 29535067Provenzi 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.
- Results publication: PubMed 26867547Rossen 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.
- Results publication: PubMed 24075091Rowe 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.
- Results publication: PubMed 27914263Sajjadian 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.
- Results publication: PubMed 29684798Makela 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsing-Yi Yu, principal investigator
Chang Gung University
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Intervention in people with Parent-Child Relations and Premature; Infant, Light-for-dates, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chun Lin (02-27135211 ext. 3356, lin1427@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Bonding Questionnaire (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525142, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.