The Effect of Prenatal Yoga-Assisted Birth Preparation Training on Fear of Childbirth and Childbirth Self-Efficacy

NCT06503133 | Not Yet Recruiting DMC

• 1 other identifier: E-77082166-302.08.01-664219
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy is a life event that requires biopsychosocial adaptation. Although pregnancy is often perceived as a positive and physiological process, women experience a wide range of fears of childbirth, from simple anxiety to severe phobic fear (tokophobia), during their pregnancy. It is thought that the feeling of experiencing pain often lies at the root of the fear of childbirth. However, fear of childbirth can be experienced for many different reasons depending on biological, psychological and sociocultural factors, personal characteristics and experiences. The prevalence of fear of childbirth in the world is 14%. In Turkey, the prevalence of fear of childbirth varies between 16% and 69%, and 21% of women experience fear of childbirth at a clinical level. In general, fear is a physiological reaction that is important for the safety of the individual, and it is thought that low-level fear of childbirth will prepare individuals for parenting. However, uncontrollable fear of childbirth can lead to physical, emotional and behavioural changes that negatively affect the woman's daily life, prolonged labour and childbirth complications. Most importantly, women who cannot cope with the fear of childbirth may perceive cesarean section as the only solution and turn to elective cesarean section. The total cesarean section rate in Turkey is 52%, which is much higher than the World Health Organization's acceptable cesarean section rate. Fear of childbirth has been accepted as an important public health problem that needs intervention both in the world and in our country, and research on fear of childbirth has accelerated, especially in the last twenty years.

Conditions

Fear of Childbirth; Childbirth Self Efficacy

Keywords

Birth preperation training; Prenatal yoga; Fear of childbirth; Childbirth self efficacy

Outcome Measures

Primary Outcomes (2)

• Fear of Childbirth

  Fear of Childbirth (Measurement will be made using the Wijma Birth Expectation/Experience Scale A version. In the 6-point Likert type scale, 0 means "completely", and 5 means "not at all". The lowest score that can be obtained from the scale is 0, while the highest score is 165. It is interpreted that as the score obtained from the scale increases, the fear of birth experienced by women increases.)

  Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement

• Childbirth Self Efficacy

  Childbirth self-efficacy (Measurements will be made with the Childbirth Self Efficacy Scale-Short Form. The scale has two sub-dimensions. Each item is scored between 1 and 10 on the Likert-type scale. The lowest score on the scale is 32, and the highest If it is high, it is 320 points. As the total score obtained from the scale increases, self-efficacy regarding birth increases.)

  Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement

Study Arms (2)

Prenatal Yoga-Supported Birth preparation Training Group

EXPERIMENTAL

Participants in this group will receive a 6-week prenatal yoga-supported birth preparation training program based on Albert Bandura's self-efficacy theory.

Other: Birth preparation training; Other: Prenatal yoga practice

Birth Preparation Training Group

ACTIVE COMPARATOR

Participants in this group will receive a 6-week birth preparation training program based on Albert Bandura's self-efficacy theory. After the post-test measurements are taken, participants in this group will also be offered the opportunity to apply prenatal yoga.

Other: Birth preparation training

Interventions

Birth preparation training OTHER

Birth preparation training is based on Albert Bandura's self-efficacy theory. It is a 60-minute training once a week. The first 10 minutes of the training are devoted to the initial activity, 40 minutes to sharing the training content, and 10 minutes to answering the participants' questions and receiving feedback. The training will be conducted in closed groups via the online meeting program (Zoom®).

Birth Preparation Training Group; Prenatal Yoga-Supported Birth preparation Training Group

Prenatal yoga practice OTHER

Prenatal yoga practice is a 60-minute practice once a week. The first 5 minutes of the prenatal yoga practice are devoted to guided meditation, 40 minutes to active asanas (yoga pose), 5 minutes to pranayama practice (breathing exercise) and 10 minutes to savasana (relaxing yoga pose). Prenatal yoga practice will be conducted in closed groups via the online meeting program (Zoom®)

Prenatal Yoga-Supported Birth preparation Training Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women between the ages of 18-35 and have a single and healthy fetus at 24-32 weeks of gestation will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being primiparous
• Being between the ages of 18 -35
• Having a single and healthy fetus
• being in the pregnancy week
• Being no psychiatric diagnosis or treatment
• Using an online meeting program (Zoom®)

You may not qualify if:

• Women doing body-mind-based exercises (yoga, meditation, progressive muscle relaxation, mindfulness, etc.).
• Women taking birth preparation training
• Women having a regular exercise habit of approximately 90-150 minutes per week
• Women with a high-risk pregnancy diagnosis
• Having become pregnant through assisted reproductive techniques
• According to the Wijma delivery expectancy questionnaire-A scale score, women with severe fear of childbirth will be excluded and referred to psychiatry.

Sponsors & Collaborators

• Kocaeli University: lead
• Lokman Hekim University: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

Location

Central Study Contacts

Eda SIMSEK SAHIN

CONTACT

(0262) 303 47 01; simsekeda24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant blinding is planned to prevent bias in the research. At the beginning of the study, all participants will be informed that prenatal yoga-supported online birth preparation training will be applied, but the start times of prenatal yoga practice may vary depending on the groups to which they will be randomly assigned, and they will be assigned to the experimental and control groups by randomization by an independent researcher. After the final measurements are taken, the participants in the control group will also undergo prenatal yoga practice. In addition, the independent researcher will make the post-test measurements. Data collected by the independent researcher will be ambiguously coded as A and B. The data will be analyzed and reported by an independent statistician. The groups will be unclear during the analysis and reporting phase.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research is a single-centre parallel randomized controlled experimental study.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)