NCT07199140

Brief Summary

Study Type and Aim: This clinical study aims to examine the effects of haptonomy practices on appreciation of bodily functionality and childbirth self-efficacy among healthy pregnant women. The study seeks to determine whether haptonomy can enhance these two outcomes. Key Research Questions: Do haptonomy practices increase appreciation of bodily functionality in pregnant women? Do haptonomy practices increase childbirth self-efficacy in pregnant women? Comparison: Researchers will compare an intervention group receiving haptonomy sessions with a control group receiving only routine prenatal care to evaluate the effects of the intervention. Participants will: Participants will provide written informed consent to take part in the study. Pregnant women in the intervention group will attend four haptonomy sessions, each lasting approximately 45 minutes and held at 7-day intervals. Sessions will include practices to enhance body awareness, relaxation techniques, connecting with the baby, and affirmations supporting bodily functionality and childbirth self-efficacy. Pregnant women in the control group will receive routine prenatal care and follow-up only. All participants will complete pretest and posttest measures assessing appreciation of bodily functionality and childbirth self-efficacy. Keywords: Haptonomy, Vaginal birth, Pregnancy, Prenatal care, Body functionality appreciation, Birth self-efficacy

Trial Health

63
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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

September 8, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 8, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

HaptonomyPregnancyBody functionality appreciationVaginal birthPrenatal careBirth self-efficacy

Outcome Measures

Primary Outcomes (3)

  • The sociodemographic characteristics of the participants and their homogeneous distribution according to the experimental and control groups

    Pregnancy Introductory Form: The pregnancy introductory form, developed based on the literature, was designed to evaluate the demographic and obstetric characteristics of individuals during pregnancy, their birth preferences, fears, social support status, and similar factors. The form consists of a total of 15 questions.

    baseline

  • Body Functionality Appreciation Scale:

    This unidimensional 7-item scale measures individuals' appreciation of their body's functionality. It evaluates psychological aspects such as body functionality awareness, body positivity, and body acceptance. The scale is scored on a 5-point Likert scale (1=Strongly disagree, 5=Strongly agree), with total scores ranging from 7 to 35. Higher scores indicate a greater level of appreciation and respect for what one's body can do. The Turkish adaptation reported a Cronbach's alpha of 0.83.

    12 weeks

  • Birth Self-Efficacy Inventory:

    This inventory measures self-efficacy levels during labor. It consists of two subscales: outcome expectancy (OE) and efficacy expectancy (EE), each containing 16 items. Total scores range from 32 to 320. Responses are rated on a 1-10 Likert scale. In the OE subscale, 1 means "not at all useful" and 10 means "very useful." In the first 13 items of the EE subscale, 1 means "completely sure" and 10 means "not at all sure," while items 14-16 are scored in reverse: 1 means "not at all sure" and 10 means "completely sure." Items 1-13 of the EE subscale are reverse-scored. The overall Cronbach's alpha reliability coefficient of the inventory is 0.82.

    12 weeks

Study Arms (2)

Haptonomy Intervention

EXPERIMENTAL

Participants receive four sessions of haptonomy during pregnancy.

Behavioral: Haptonomy

Control

NO INTERVENTION

Participants receive routine prenatal care without additional intervention

Interventions

HaptonomyBEHAVIORAL

Pregnant participants will receive a four-session haptonomy intervention, each lasting approximately 45 minutes. The sessions aim to enhance body awareness, reduce childbirth-related anxiety, and support birth self-efficacy. The intervention includes breathing exercises, relaxation techniques, and activities promoting maternal-fetal interaction.

Haptonomy Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 years or older
  • Spontaneous pregnancy at 28 weeks of gestation
  • Primiparous (first pregnancy)
  • Able to read and write in Turkish
  • Healthy singleton pregnancy

You may not qualify if:

  • Any health problems in the mother or fetus
  • History of complications during pregnancy
  • Diagnosed psychiatric disorders or use of psychiatric medication
  • Any physical, mental, or cognitive disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa University, Erbaa Faculty of Health Sciences

Erbaa, Tokat Province, 6500, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
No other parties beyond those listed above are blinded in this clinical trial.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a randomized controlled, parallel-group interventional study designed to evaluate the effects of haptonomy on pregnant women's body functionality appreciation and childbirth self-efficacy. Participants in the intervention group will receive four haptonomy sessions, while the control group will receive standard prenatal care. Pre- and post-intervention assessments will be conducted to measure outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, phD

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 30, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study is limited to internal analysis and participant confidentiality will be maintained.

Locations