- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07263750
Effect of Haptonomy on Prenatal Attachment and Fear of Childbirth in Primiparous Couples
The Effect of Haptonomy Application for Primiparous Pregnant Women and Their Partners on Prenatal Attachment and Fear of Childbirth: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim: This study was designed to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.
Methods: This randomized controlled experimental study will include primiparous pregnant women and their partners (36 couples in the experimental group and 36 couples in the control group) who apply to the childbirth education class of a public hospital in Turkey and are between 24-26 weeks of gestation.
The experimental group will receive haptonomy education in the childbirth class. Afterwards, a video-based haptonomy program will be delivered via e-mail or WhatsApp. Couples will be asked to perform haptonomy exercises once a week for 40 minutes over five weeks. No intervention will be applied to the control group.
Data will be collected before the intervention and at the end of the fifth week using the Personal Information Form, Prenatal Attachment Inventory (PAI), Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), Paternal-Fetal Attachment Scale (PFAS), and Fathers' Fear of Childbirth Scale (FFOC).
Data analysis will include frequency and percentage distributions, chi-square test, t-test, Mann-Whitney U test, repeated measures analysis, two-way ANOVA, Friedman test, and Cohen's d test.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nilüfer Tuğut, Prof. Dr.
- Phone Number: +0905327754828
- Email: nlfrtugut@gmail.com
Study Contact Backup
- Name: sibel dilmen, lectuer
- Phone Number: +905532628295
- Email: dilmensibel51@gmail.com
Study Locations
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Sivas
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Merkez, Sivas, Turkey (Türkiye), 58000
- Recruiting
- Sivas Cumhuriyet University
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Contact:
- Nilüfer Tugut, Prof.Dr.
- Phone Number: +0905327754828
- Email: nlfrtugut@gmail.com
-
Contact:
- sibel dilmen, lectuer
- Phone Number: 05532628295
- Email: dilmensibel51@gmail.com
-
Principal Investigator:
- nilüfer tuğut, professor
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• At least a primary school graduate
- Between the 24th and 26th weeks of pregnancy
- According to calculations made by ultrasound based on the last menstrual period or, for pregnant women who do not know their last menstrual period, between the 24th and 26th weeks of pregnancy
- Primiparous
- No history of abortion/curettage
- Planned/desired pregnancy
- Desired baby gender
- Living with spouse
- Attended pregnancy classes
- Able to use technology such as computers and mobile phones to watch videos
- No barriers to understanding questions and responding
- No previous training on fear of childbirth or prenatal bonding
- Not having previously received education on haptonomy or practised haptonomy
- Not undergoing infertility treatment
- Being between the ages of 19 and 35
Exclusion Criteria:
• Be at least 26 weeks pregnant
- Live separately from spouse
- Have an unplanned/unwanted pregnancy
- Not want the baby to be of a specific gender
- Not use technology
- Be a high-risk pregnancy
- Have previously received training on fear of childbirth and prenatal bonding
- Having previously received training in haptonomy and practised haptonomy
- Deciding to discontinue haptonomy practice after the study began and/or giving birth prematurely before completing the practice sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
Haptonomy training will be provided to the experimental group within the childbirth class.
Afterwards, the video-based haptonomy program will be sent via e-mail or WhatsApp.
Couples will be asked to practice haptonomy exercises for five weeks, one 40-minute session per week.
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Since there are no studies in the literature evaluating the effect of planned video modelling haptonomy on prenatal bonding and fear of childbirth in expectant mothers and fathers, it is believed that the results obtained from this study will contribute significantly to the literature by guiding and shedding light on future studies.
Other Names:
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No Intervention: control group
Standard of care Group The control group will not receive any treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
Time Frame: Baseline
|
The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type.
The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
|
Baseline
|
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Prenatal Attachment Inventory (PAI)
Time Frame: Baseline
|
The PAI is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period.
Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale.
Increase in the score obtained by pregnant indicates that level of attachment also increases.
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Baseline
|
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Paternal-Fetal Attachment Scale (PFAS)
Time Frame: Baseline
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PFAS is a validated scale used to determine the level of paternal-fetal attachment.
The responses are rated on a four-point Likert scale ranging from 1 to 4. The minimum possible total score is 23, and the maximum is 92.
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Baseline
|
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Fathers' Fear of Childbirth Scale (FFOC)
Time Frame: Baseline
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The FFOC is a validated instrument used to determine fathers' level of fear related to childbirth.
The responses are rated on a five-point Likert scale ranging from 1 to 5. The minimum possible total score is 17, and the maximum is 85.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal Attachment Inventory (PAI)
Time Frame: Week 5
|
The PAI is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period.
Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale.
Increase in the score obtained by pregnant indicates that level of attachment also increases.
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Week 5
|
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Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
Time Frame: Week 5
|
The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type.
The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
|
Week 5
|
|
Paternal-Fetal Attachment Scale (PFAS)
Time Frame: Week 5
|
PFAS is a validated scale used to determine the level of paternal-fetal attachment.
The responses are rated on a four-point Likert scale ranging from 1 to 4. The minimum possible total score is 23, and the maximum is 92.
|
Week 5
|
|
Fathers' Fear of Childbirth Scale (FFOC)
Time Frame: Week 5
|
The FFOC is a validated instrument used to determine fathers' level of fear related to childbirth.
The responses are rated on a five-point Likert scale ranging from 1 to 5. The minimum possible total score is 17, and the maximum is 85.
|
Week 5
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nilüfer Tugut, Prof. Dr., Cumhuriyet University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OHU-DKH-SD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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