NCT07263750

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 31, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

fear of childbirthpregnantfatherprenatal attachmenthaptonomia

Outcome Measures

Primary 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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (4)

  • Prenatal Attachment Inventory (PAI)

    Week 5

  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

    Week 5

  • Paternal-Fetal Attachment Scale (PFAS)

    Week 5

  • Fathers' Fear of Childbirth Scale (FFOC)

    Week 5

Study Arms (2)

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.

Behavioral: Haptonomy

control group

NO INTERVENTION

Standard of care Group The control group will not receive any treatment

Interventions

HaptonomyBEHAVIORAL

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.

Also known as: Haptonomy, as a field dealing with emotional contact through touch, describe the relationship between parents and the unborn baby.
experimental group

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Merkez, Sivas, 58000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Nilüfer Tugut, Prof. Dr.

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilüfer Tuğut, Prof. Dr.

CONTACT

sibel dilmen, lectuer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 31, 2025

First Posted

December 4, 2025

Study Start

March 26, 2025

Primary Completion

March 27, 2026

Study Completion

April 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations