Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525142
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
The Effectiveness of Audiovisual Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Audiovisual Intervention on the Parent-Child Bonding Parental Role Perception and Well-Being in Fathers of Premature Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 fathers 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 fathers 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
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 fathers 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 fathers 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 1During the first three days the researchers will provide a storybook to the father of the premature infant and the researchers assist in recording the fathers voice of the storybook in the form of MP4 recording At the fourth day one hour after the baby feeding the fathers voice will be played by the player to the baby for 2 consecutive days 2 timesday 10 minutestime The babys 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 babys birth sleeping in the incubator the babys reaction behavior will be taken with a mobile phone 1 timeday 5 minutestime for 3 consecutive days the image feedback is delivered to the father in person
Group 3This group is a control group The fathers and preterm infants will not receive interventions conducted in group 1 and 2
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 1During the first three days the researchers will provide a storybook to the father of the premature infant and the researchers assist in recording the fathers voice of the storybook in the form of MP4 recording At the fourth day one hour after the baby feeding the fathers voice will be played by the player to the baby for 2 consecutive days 2 timesday 10 minutestime The babys 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 babys birth sleeping in the incubator the babys reaction behavior will be taken with a mobile phone 1 timeday 5 minutestime for 3 consecutive days the image feedback is delivered to the father in person
Group 3This group is a control group The fathers and preterm infants will not receive interventions conducted in group 1 and 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None