Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth

Not Applicable

Completed

• Conditions: Mindfulness-Based Stress Reduction

• Registration Number: NCT06699550
• Lead Sponsor: Trakya University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Primary Completion: 2024-03-10
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychological Well-Being Scale	change from starting to 4. and 8. week	The Psychological Well-Being Scale, developed, consists of eight items aimed at measuring psychological well-being levels. The internal consistency coefficient of the scale is 0.87. The Turkish adaptation of the Psychological Well-Being Scale was conducted, who found the internal consistency coefficient to be 0.87 as well. The scale is rated on a 1-7 point scale, with higher scores indicating that the individual possesses psychological strengths.
Perceived Stress Scale	change from starting to 4. and 8. week	The Perceived Stress Scale, consisting of 14 items, was developed to measure the degree to which individuals perceive certain situations in their lives as stressful. The scale is assessed using a 5-point Likert-type scoring system, ranging from 0 to 4. It comprises two factors: 'perception of stress/discomfort' and 'perception of inadequacy.' The scale allows for a maximum score of 56 and a minimum score of 0, with scores increasing as stress levels rise. The validity and reliability of the scale were established. The Turkish version of the Perceived Stress Scale (PSS-14) has an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87.
Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A	change from starting to 4. and 8. week	The scale, consists of 33 items. Responses to the items are rated on a scale from 0 to 5, utilizing a six-point Likert-type format. The maximum score attainable on the scale is 165, while the minimum is 0. A higher total score indicates a greater level of fear. Specifically, a scale score of 85 or above reflects clinical levels of birth fear, scores between 66 and 84 indicate severe fear, scores between 38 and 65 denote moderate fear, and scores of 37 and below signify mild levels of birth fear. The Cronbach's alpha coefficient for the scale is found to be 0.88 for first-time mothers (primiparous) and 0.90 for mothers who have given birth before (multiparous).

Trial Locations

Locations (1)

Bartın University; 🇹🇷 Bartın, Turkey