The Effect of Haptonomy Practice on Risk Perception, Distress and Attachment in Pregnant Women With Prenatal Loss (Haptonomy)

February 4, 2026 updated by: ZEYNEP KALKAN, Inonu University
The research was conducted to determine the effects of haptonomy application given to pregnant women who experienced prenatal loss on risk perception, distress and attachment. The sample of this randomized controlled study consisted of 126 pregnant women, 63 in the experimental group and 63 in the control group, who applied to the Diyarbakır Ergani State Hospital Gynecology and Obstetrics Clinic and who had experienced at least one prenatal loss and were in the 24-32nd week of pregnancy. Data were obtained using the "Personal Introduction Form", "Perception of Pregnancy Risk Scale (PPRS)", "Tilburg Pregnancy Distress Scale (TPDS)" and "Prenatal Attachment Inventory (PAI)". Haptonomics were performed in 5 interviews at 7-10 day intervals with music determined by the researcher and the pregnant woman.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled study was carried out to examine the effects of haptonomy on risk perception, psychological distress, and prenatal attachment among pregnant women who had experienced prenatal loss. The study population consisted of pregnant women between 24 and 32 weeks of gestation who had a history of prenatal loss. A total of 126 eligible participants were enrolled and randomly allocated into intervention and control groups.

Participants in the intervention group received haptonomy sessions conducted by the researcher, accompanied by music selected collaboratively with the pregnant woman. The intervention consisted of five sessions performed at intervals of 7-10 days. The control group received routine prenatal follow-up care without any additional intervention.

Data collection tools included a Personal Information Form, the Pregnancy Risk Perception Scale (PRPS), the Tilburg Pregnancy Distress Scale (TPDS), and the Prenatal Attachment Inventory (PAI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having a single and live pregnancy,
  • Pregnant women between 24 and 32 weeks of gestation, which is considered a suitable period for the application of haptonomy,
  • No maternal-fetal risks associated with pregnancy (preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, fetal anomaly, intrauterine growth retardation, etc.),
  • Having previously experienced prenatal loss,
  • Pregnant women who agreed to participate in the study were included in the study.

Exclusion Criteria:

  • Getting pregnant with assisted reproductive techniques,
  • Those with limited communication and perception skills,
  • Pregnant women who were not between 24-32 weeks of gestation were excluded from the 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
In this phase of the research, a midwifery intervention was implemented within the scope of "Haptonomy", consisting of a total of five stages, each lasting between 30 and 90 minutes.
Behavioral: Haptonomy
Haptonomy intervention was conducted by the researcher and consisted of five sessions delivered at 7-10 day intervals. Sessions were performed with pregnant women who had experienced prenatal loss, accompanied by music selected collaboratively by the researcher and the participant.
No Intervention: control group
The control group received no intervention and received routine care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analyses of the experimental group data included in the study were carried out using the SPSS 25 program.
Time Frame: Total evaluation of the experimental group data took five months from the date of registration.
Following the haptonomy intervention applied within the scope of the study, the levels of risk perception during pregnancy, risk perception towards the baby, and risk perception towards the pregnant woman herself were examined. The pregnant woman's perception of risk to herself and her baby will be assessed using the Perception of Pregnancy Risk Scale. The scale consists of nine items and includes two subdimensions. Each item is rated on a 0-100 mm visual analogue scale, anchored by the statements "no risk at all" and "extremely high risk." The total scale score is calculated by summing the scores of all nine items and dividing the total by nine. Higher scores indicate greater perceived risk related to both the pregnant woman and her baby. The subdimensions assess risk perception related to the baby (items 2, 6, 7, 8, and 9) and risk perception related to the pregnant woman herself (items 1, 3, 4, and 5).
Total evaluation of the experimental group data took five months from the date of registration.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analyses of the experimental group data included in the study were carried out using the SPSS 25 program.
Time Frame: Total collection and evaluation of control group data took five months from the date of patient registration.

The level of psychological distress experienced during pregnancy will be assessed using the Tilburg Pregnancy Distress Scale. The scale consists of 16 items rated on a 4-point Likert scale (0= often, 1= quite often, 2= sometimes, 3= rarely or never). Items 3, 5-7, 9-14, and 16 are reverse scored. The total score ranges from 0 to 48. A cut-off score of ≥28 indicates that the pregnant woman is at risk for pregnancy-related distress.

The prenatal attachment level will be assessed using the Prenatal Attachment Inventory. The inventory consists of 21 items rated on a 4-point Likert scale (1= never, 2= sometimes, 3= often, 4= always). The total score ranges from 21 to 84, with higher scores indicating higher levels of prenatal attachment.
Total collection and evaluation of control group data took five months from the date of patient registration.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ZEYNEP KALKAN, MİDWİFERY, inonu universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/4971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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