NCT07403240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

September 2, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

DistressMidwifeRisk perception in pregnancyHaptonomyPrenatal attachmentPrenatal loss

Outcome Measures

Primary Outcomes (1)

  • Analyses of the experimental group data included in the study were carried out using the SPSS 25 program.

    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 Outcomes (1)

  • Analyses of the experimental group data included in the study were carried out using the SPSS 25 program.

    Total collection and evaluation of control group data took five months from the date of patient registration.

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

The control group received no intervention and received routine care.

Interventions

HaptonomyBEHAVIORAL

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.

experimental group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince this study was conducted on pregnant women, it is mandatory for the individual to be female.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

inönü UNIVERSITY

Malatya, Turkey (Türkiye)

Location

Related Links

Study Officials

  • ZEYNEP KALKAN, MİDWİFERY

    İnönü Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Midwife

Study Record Dates

First Submitted

September 2, 2025

First Posted

February 11, 2026

Study Start

September 20, 2023

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

February 11, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations