Fear of ChildbirthNCT07263750
Effect of Haptonomy on Prenatal Attachment and Fear of Childbirth in Primiparous Couples
A study testing Haptonomy in people with Fear of Childbirth and Prenatal Attachment, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Prenatal Attachment
- What is being tested?
- Haptonomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Merkez, Sivas, 58000
Nilüfer Tugut, Prof.Dr., +0905327754828, nlfrtugut@gmail.com
sibel dilmen, lectuer, 05532628295, dilmensibel51@gmail.com
About this study
Official title: The Effect of Haptonomy Application for Primiparous Pregnant Women and Their Partners on Prenatal Attachment and Fear of Childbirth: A Randomized Controlled Study
This study was planned to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.
Read the 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.
- Conditions
- Fear of Childbirth, Prenatal Attachment
- Being tested
- Haptonomy
- Keywords
- fear of childbirth, pregnant, father, prenatal attachment, haptonomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaptonomyBehavioural
Also called Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Behavioral: Haptonomy |
| control group | No intervention | Standard of care Group The control group will not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Attachment Inventory (PAI)
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.
Measured: Baseline
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
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.
Measured: Baseline
Paternal-Fetal Attachment Scale (PFAS)
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.
Measured: Baseline
Fathers' Fear of Childbirth Scale (FFOC)
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.
Measured: Baseline
Secondary outcomes (4)
Prenatal Attachment Inventory (PAI)
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.
Measured: Week 5
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
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.
Measured: Week 5
Paternal-Fetal Attachment Scale (PFAS)
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.
Measured: Week 5
Fathers' Fear of Childbirth Scale (FFOC)
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.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start26 Mar 2025
- Primary completion27 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel DİLMEN, Nigde Omer Halisdemir University
- Investigators
- Nilüfer Tugut, Prof. Dr., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263750
- Sponsor's protocol ID
- OHU-DKH-SD-01
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozbek H, Pinar SE. The effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment: randomized controlled experimental study. Curr Psychol. 2022 Jul 16:1-10. doi: 10.1007/s12144-022-03388-1. Online ahead of print.
PubMed 35874964
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Haptonomy Application for Primiparous Pregnant Women and Their Partners on Prenatal Attachment and Fear of Childbirth: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07263750
- Acronym / sponsor ID
- OHU-DKH-SD-01
- Conditions
- Fear of Childbirth, Prenatal Attachment
- Keywords
- fear of childbirth, pregnant, father, prenatal attachment, haptonomia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
This study was planned to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: HaptonomyHaptonomy 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. |
| control group | No intervention | –Standard of care Group The control group will not receive any treatment |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- • At least a primary school graduate
Key exclusion criteria (9 listed)
- • Be at least 26 weeks pregnant
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 |
|---|---|---|
| HaptonomyAlso: Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.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. | Behavioural | experimental group |
Primary outcome
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.
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.
Paternal-Fetal Attachment Scale (PFAS)
Time frame: Baseline
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.
Fathers' Fear of Childbirth Scale (FFOC)
Time frame: Baseline
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.
4 secondary outcomes
Prenatal Attachment Inventory (PAI)
Time frame: Week 5
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
Time frame: Week 5
Paternal-Fetal Attachment Scale (PFAS)
Time frame: Week 5
Fathers' Fear of Childbirth Scale (FFOC)
Time frame: Week 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 35874964Ozbek H, Pinar SE. The effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment: randomized controlled experimental study. Curr Psychol. 2022 Jul 16:1-10. doi: 10.1007/s12144-022-03388-1. Online ahead of print.
- 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.
Nilüfer Tugut, Prof. Dr. principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptonomy in people with Fear of Childbirth and Prenatal Attachment, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 15 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilüfer Tuğut, Prof. Dr. (+0905327754828, nlfrtugut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Attachment Inventory (PAI) (time frame: Baseline). 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 NCT07263750, which also lists 1 linked publication.
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 3 Feb 2026.