- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417384
Prenatal Haptonomy-Based Support
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
Status
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilal Ozbek, Asist. Prof. Dr.
- Phone Number: +905053873773
- Email: hilal.ozbek@gop.edu.tr
Study Contact Backup
- Name: Simay Bartınlı, Master's Student
- Phone Number: 05423105598
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Hilal Ozbek, Tokat Gaziosmanpasa University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TR TOKAT03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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