NCT07417384

Brief Summary

This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027. Eligible participants will be informed about the study objectives, procedures, potential benefits and risks, and voluntary participation principles. Written informed consent will be obtained prior to enrollment. Participant confidentiality will be ensured in accordance with data protection regulations, and unique identification codes will be assigned. At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory (PAI), and Spousal Support Scale (SSS). Following baseline assessment, participants will be randomly allocated into one of three groups: Partner-supported haptonomy group Mother-supported haptonomy group Midwife-supported haptonomy group The haptonomy-based intervention will be delivered once weekly for three consecutive weeks in a hospital-based setting. Each session will last approximately 30 minutes and will follow a standardized protocol including structured affective touch, body awareness facilitation, emotional observation, and structured session closure. All sessions will be conducted by a research assistant who completed the Prenatal Haptonomy Instructor Training (January 29-31, 2026). The principal investigator will supervise and monitor the scientific integrity of the study. Outcome assessments will be conducted at three time points: T0 (Baseline): Prior to intervention T1 (Post-session 1): 24-48 hours after the first haptonomy session T2 (Post-intervention): 24-48 hours after the third haptonomy session The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Data completeness will be checked after each assessment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Apr 2026

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 Progress9%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 11, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

HaptonomyPrenatal HaptonomyPrenatal AttachmentMaternal-Fetal AttachmentPartner Support; PregnancyRandomized Controlled TrialPsychosocial InterventionPartner SupportPregnancy

Outcome Measures

Primary Outcomes (1)

  • Prenatal Attachment

    Change from baseline in prenatal attachment as measured by the Prenatal Attachment Inventory (PAI). The Prenatal Attachment Inventory (PAI), developed by Mary Muller (1993), consists of 21 items rated on a 4-point Likert scale (1 = Almost Never, 4 = Almost Always). Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment. There are no reverse-scored items. The scale is unidimensional and evaluated using total score.

    Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)

Secondary Outcomes (1)

  • Perceived Partner Support

    Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)

Study Arms (3)

Partner-Supported Haptonomy Group

EXPERIMENTAL

Pregnant women receiving haptonomy-based prenatal support together with their partners once weekly for three consecutive weeks.

Behavioral: Prenatal Haptonomy-Based Support

Mother-Supported Haptonomy Group

EXPERIMENTAL

Pregnant women receiving haptonomy-based prenatal support together with their mothers once weekly for three consecutive weeks.

Behavioral: Mother-Supported Haptonomy Group

Midwife-Supported Haptonomy Group

EXPERIMENTAL

Pregnant women receiving haptonomy-based prenatal support delivered by a trained midwife once weekly for three consecutive weeks.

Behavioral: Midwife-Supported Haptonomy Group

Interventions

A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's partner. The protocol includes affective touch facilitated by the partner, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.

Partner-Supported Haptonomy Group

A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's mother. The protocol includes affective touch facilitated by the mother, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.

Mother-Supported Haptonomy Group

A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted by a trained midwife. The protocol includes affective touch provided by the midwife, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.

Midwife-Supported Haptonomy Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-45 years
  • Attending antenatal follow-up at Tokat Gaziosmanpaşa University Hospital
  • Gestational age between 20 and 32 weeks
  • Ability to communicate in Turkish
  • Willingness to participate and provide written informed consent

You may not qualify if:

  • High-risk pregnancy (e.g., preeclampsia, placenta previa, gestational diabetes requiring insulin)
  • Diagnosed psychiatric disorder
  • Multiple pregnancy
  • Known fetal anomaly
  • Participation in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hilal Ozbek

    Tokat Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Ozbek, Asist. Prof. Dr.

CONTACT

Simay Bartınlı, Master's Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Participants will be randomly assigned to one of three parallel groups (partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy) and followed for three weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asist. Prof. Dr.

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to participant confidentiality and institutional data protection policies. Only aggregate study results will be published.