- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403240
The Effect of Haptonomy Practice on Risk Perception, Distress and Attachment in Pregnant Women With Prenatal Loss (Haptonomy)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye)
- Inonu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
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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.
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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.
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No Intervention: control group
The control group received no intervention and received routine care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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).
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Total evaluation of the experimental group data took five months from the date of registration.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ZEYNEP KALKAN, MİDWİFERY, İnönü Üniversitesi
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2023/4971
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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