Clinical trial NCT06699550: Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth
Official title: The Effects of Haptonomy Application and Mindfulness-based Stress Reduction Program on Psychological Well-being Levels, Perceived Stress, and Fear of Childbirth in Primiparous Mothers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness-Based Stress Reduction
Keywords: Primiparous women
Haptonomy
Mindfulness-based stress reduction program
Psychological well-being
Perceived stress
Fear of childbirth
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Bartın Unıversity
First posted: 2024-11-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Psychological Well-Being Scale
timeFrame: change from starting to 4. and 8. week
measure: Perceived Stress Scale
timeFrame: change from starting to 4. and 8. week
measure: Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A
timeFrame: change from starting to 4. and 8. week
Secondary outcomes:
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
References: