Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07417384

Prenatal Haptonomy-Based Support

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prenatal Haptonomy-Based Support

Behavioral

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.

Mother-Supported Haptonomy Group

Behavioral

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.

Midwife-Supported Haptonomy Group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilal Ozbek, Asist. Prof. Dr.

CONTACT

[email protected]

+905053873773

Simay Bartınlı, Master's Student

CONTACT

05423105598

Sponsors and collaborators

Lead sponsor

Hilal Özbek

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.