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Completed

NCT Number: NCT06699550

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

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.

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Key information

Conditions

Mindfulness-based Stress Reduction Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bartın University

Bartın, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

haptonomy

Other

The session transitioned to energy work and dream visualization. The researcher and the pregnant participant placed their left hands on each other's hearts. The goal was for the participants to feel the energy flowing between them, sense their hearts, open their third eye, and prepare their hands. This exercise aimed to enhance the pregnant participant's confidence in her own emotions and body by recognizing her feelings and physical sensations. Next, the researcher and the pregnant participant placed their right hands on the participant's forehead and their left hands over their hearts. This positioning facilitated the pregnant participant in visually sensing the presence of her baby. It was intended to promote communication between the mother and her baby at both a physical and spiritual level.

Mindfulness-based stress reduction program

Other

Participants were introduced to each other and provided with information related to pregnancy. The Mindfulness-Based Stress Reduction Program (MBSR) was introduced. The participants shared their levels of well-being, stress, coping mechanisms for fear of childbirth, and their expectations from the MBSR program. Awareness of habitual behaviors was facilitated. Afterwards, breath-focused meditation and dried fruit meditation were practiced. Participants were encouraged to maintain awareness of activities performed at any time during the day. Lastly, body scan meditation was taught, and participants were instructed to repeat the practice throughout the week using audio recordings.

Other names: Mindfulness

Primary outcomes

  1. Psychological Well-Being Scale

    Time frame: 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.

  2. Perceived Stress Scale

    Time frame: 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.

  3. Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Bartın Unıversity

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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