Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth (NCT06699550) | Clinical Trial Compass
CompletedNot Applicable
Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth
Turkey (Türkiye)40 participantsStarted 2024-01-02
Plain-language summary
Aim: The aim of this project was to examine the effects of haptonomy application and the mindfulness-based stress reduction program (MBSRP) on the psychological well-being levels, perceived stress, and fear of childbirth in primiparous women.
Materials and Methods: This prospective, single-blind, randomized controlled study was conducted between January 1, 2024, and October 1, 2024. A total of 120 primiparous women (40: control group, 40: haptonomy group, and 40: MBSRP group) who volunteered to participate in the study were randomly assigned to three groups: the intervention group (haptonomy and MBSRP) and the control group. The haptonomy and MBSRP groups received individual and face-to-face interventions for 8 weeks. At baseline, the 4th week, and the 8th week, the "Personal Data Collection Form," "Psychological Well-Being Scale," "Perceived Stress Scale," and "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ/A) A version" were administered, based on a literature review.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women who are married and experiencing their first pregnancy.
* Aged 18 years or older.
* Able to read, write, and understand Turkish.
* Residing in the city center where the study is conducted.
* No physical or psychological health issues for themselves or their baby.
* Experiencing a spontaneous pregnancy between 22-28 weeks of gestation.
* Have not previously undergone BFTSAP (Body-Focused Therapy and Support for Anxiety during Pregnancy) and haptonomy applications.
* Pregnant women who agree to participate in the study.
Exclusion Criteria:
* Those with a known and diagnosed psychiatric disorder.
* Individuals who have previously undergone cognitive therapy.
* Experiencing severe levels of anxiety, stress, and depression.
* Having chronic diseases (such as hypertension, diabetes mellitus, heart diseases) that existed before or have emerged during pregnancy.
* Individuals who have not attended the first two sessions of the MBSR (Mindfulness-Based Stress Reduction) program and haptonomy applications.
* Lacking a partner or relative who can provide support and assistance at home during the applications.
* Without access to technical technology support.
* Pregnant women who do not agree to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psychological Well-Being Scale
Timeframe: change from starting to 4. and 8. week
2
Perceived Stress Scale
Timeframe: change from starting to 4. and 8. week
3
Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A