Prenatal Haptonomy-Based Support

February 27, 2026 updated by: Hilal Özbek

Effects of Haptonomy-Based Support Approaches in the Prenatal Period on Prenatal Attachment and Perceived Partner Support - A Randomized Controlled Study

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.

Study Overview

Detailed Description

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. Participants will receive verbal and written information about the study, written informed consent will be obtained, and all data will be stored using coded identifiers in accordance with confidentiality principles.

At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory, and Spousal Support Scale. Participants will then be randomly assigned to one of three groups: partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy. The haptonomy-based intervention will be delivered over three consecutive weeks, once per week, following a standardized protocol, with each session lasting approximately 30 minutes and conducted in a hospital setting. Interventions will be carried out by a research assistant trained in prenatal haptonomy and scientifically supervised by the principal investigator.

Haptonomy sessions will include structured affective touch, body awareness facilitation, emotional observation, and session closure, with no invasive procedures involved. Outcome assessments will be conducted at three time points: prior to the intervention (T0), 24-48 hours after the first session (T1), and 24-48 hours after the third session (T2). The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Collected data will be analyzed using statistical methods to evaluate the effects of haptonomy-based support approaches on prenatal attachment and perceived partner support.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Simay Bartınlı, Master's Student
  • Phone Number: 05423105598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partner-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support together with their partners once weekly for three consecutive weeks.
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.
Experimental: Mother-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support together with their mothers once weekly for three consecutive weeks.
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.
Experimental: Midwife-Supported Haptonomy Group
Pregnant women receiving haptonomy-based prenatal support delivered by a trained midwife once weekly for three consecutive weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal Attachment
Time Frame: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Partner Support
Time Frame: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)

Change from baseline in perceived partner support as measured by the Spouse Support Scale (SSS).

The Spouse Support Scale (SSS), developed by Yıldırım (2005), consists of 13 items rated on a 5-point Likert scale (1 = Not appropriate at all, 5 = Completely appropriate).

Total scores range from 13 to 65. Higher total scores indicate higher perceived partner support. There are no reverse-scored items. The scale is evaluated using the total score.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Hilal Ozbek, Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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