NCT06678087

Brief Summary

Fear of childbirth If left untreated, it negatively affects women's birth process and preferences. Determining the level of fear experienced by women during pregnancy and helping them cope with this fear will help reduce the negative effects. Theta-Healing is defined as a deep meditation method based on the belief that all unwanted situations that occur in humans originate from the subconscious of the human mind and that healing will occur when the beliefs in the subconscious are resolved and changed to be beneficial to the individual. This study aims to help women with different levels of fear of childbirth cope with fear by revealing the reasons for their subconscious fear of childbirth with the ThetaHealing meditation method. This study, which is planned to be conducted as a randomized controlled trial design, aims to present a new method in midwifery care to be applied for the management of pathological fear of childbirth. In addition, it is aimed to reduce the fear of pathological childbirth and increase normal birth self-efficacy and increase the normal birth rate. The study is planned as a randomized controlled experimental study. Pregnant women will be randomized in accordance with the randomization rules. For randomization, the Random Integer Generator method in the Numbers subheading of the https://www.random.org site will be used to. The study consists of a total of 3 groups, namely the control group (A) and the experimental groups (B, C).

  • Group A will be the group that receives routine hospital and midwifery care (n=30)
  • Group B will be the group that receives childbirth preparation training at the hospital's pregnancy school in addition to routine care (n=30)
  • Group C will be the group that receives childbirth preparation training at the hospital's pregnancy school in addition to routine care and will additionally receive a childbirth and motherhood preparation meditation created with theta-healing method (n=30). The research will be conducted between May and December 2024 among pregnant women who apply to the Ankara City Hospital Gynecology and Obstetrics Department and agree to participate in the study. After the groups are formed, the researcher will collect research data from all groups using a personal information form, the Fear of Childbirth Sub-Dimension Scale of the Prenatal Self-Assessment Scale, the Self-Efficacy Scale for Normal Birth, and the Normal Birth Belief Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

October 16, 2024

Last Update Submit

March 14, 2025

Conditions

Keywords

BrainbirthFear of BirthPreparation for BirthPregnancy EducationEEGBrain WavesMeditationComplementary and Alternative MedicineThetaHealing

Outcome Measures

Primary Outcomes (5)

  • Prenatal Self-Assessment Scale- Fear of Birth Sub-Dimensions Description

    he scale is used to evaluate the adaptation of pregnant women to pregnancy and motherhood. The "Fear of Birth" subscales in the scale will be used. Items are evaluated with scores ranging from "1" to "4" (4: "Describes very much," 3: "Partly describes," 2: "Somewhat describes," 1: Does not describe at all"). The lowest score to be taken separately in the fear of birth and birth readiness sub-dimensions is 10 and the highest score is 40.

    1st measurement: at the first meeting with all study groups 2nd measurement: group a 5 days after the 1st measurement. group b and group c at the end of the training.

  • Normal Birth Belief Scale (NBS)

    Developed by Akça and Aksoy Derya in 2021 in line with the Health belief model, NBS evaluates the beliefs and tendencies of pregnant women regarding normal birth. The NEQ consists of 6 sub-dimensions and 24 items: perceived susceptibility (items 1, 2, 3), perceived severity (items 4, 5, 6, 7), perceived benefits (items 8, 9, 10, 11), perceived barriers (items 12, 13, 14, 15, 16, 17), perceived self-efficacy (items 18, 19, 20, 21) and health motivation (items 22, 23, 24). The items in the scale are five-point Likert-type and are scored as "I completely agree (5)", "I agree (4)", "I am undecided (3)", "I disagree (2)", "I completely disagree (1)". All items belonging to the NEQ perceived barriers sub-dimension (items 12, 13, 14, 15, 16, 17) are reverse scored. The lowest possible score is 24 and the highest possible score is 120. The lowest possible scores are 3 and 15 from the "perceived susceptibility" sub-dimension, lowest possible scores are 4 and 20 from the "perceived seriousness"

    1st measurement: at the first meeting with all study groups 2nd measurement: group a 5 days after the 1st measurement. group b and group c at the end of the training.

  • Self-Efficacy Scale for Normal Birth

    The scale developed by Chu et al. (2017) is a Thurstone type scale consisting of 9 items. Each item of the measurement tool is scored as "0 points = I don't trust myself, 10 points = I am very confident". The lowest score that can be obtained from the scale is 0, while the highest score is 90. As the scores obtained from the self-efficacy scale increase, the level of self-efficacy also increases. The total Cronbach Alpha value of the original scale is 0.93.

    1st measurement: at the first meeting with all study groups 2nd measurement: group a 5 days after the 1st measurement. group b and group c at the end of the training.

  • Wijma Childbirth Expectation/Experience Scale (W-DEQ) Version B

    This scale was developed by Wijma and colleagues. The aim of the scale is to assess women's fear of childbirth during their own childbirth experiences in the postpartum period. The validity and reliability study for our country was conducted by Uçar and Beji (29). The scale consists of 33 items. Each item is a 6-point Likert-type scale with scores ranging from 1 to 6, with 1 being "completely" and 6 being "not at all". The minimum score on the scale is 33, while the maximum score is 198. High scores indicate that women have high fear of childbirth. The negative loaded questions in the scale (2, 3, 6, 7, 8, 11, 12,15, 19, 20, 24, 25, 27, 31) are calculated by turning them in the opposite direction in order to ensure consistency in the measurement. W-DEQ scores are evaluated in four subgroups. These are; women with low-level fear of childbirth (W-DEQ score ≤37), women with moderate-level fear of childbirth (W-DEQ score between 38-65), women with severe fear of childbirth (W-DEQ score 6

    Measurement between 1-10 days after birth for all groups will be taken.

  • Brain Wave Measurement with Mobile EEG Device

    While all participants will watch 6-minute images of different births, their brain waves will be recorded with a mobile EEG device to record the participants' brain responses to the birth.

    1st measurement: at the first meeting with all study groups 2nd measurement: group a 5 days after the 1st measurement. group b and group c at the end of the training. 3rd measurement: at the time of labor for all groups.

Study Arms (3)

Group A control group

NO INTERVENTION

This is the group that receives routine antenatal care.

Group B Pregnancy School

OTHER

This is a group of pregnant women who receive birth preparation training at the hospital's pregnancy school in addition to routine antenatal care.

Other: pregnancy school,

group c experimental group

EXPERIMENTAL

In addition to routine antenatal care and childbirth preparation training at the hospital's pregnancy school, this group will receive childbirth and motherhood preparation meditation training prepared with the thetahealing meditation method simultaneously with the childbirth preparation training.

Other: motherhood preparation meditation training prepared with the thetahealing meditation method

Interventions

With Birth and Motherhood Preparation Meditation, all physiological and psychological reasons causing fear of birth will be addressed. How to do the meditation will be taught by the practitioner in the course. The root belief analysis study for each topic is carried out with the questions of who, what, when, where, why and how. Then, the reprogramming work that allows the change of that belief, feeling, emotion will be done with methods specific to the technique. The topics to be worked on during meditation each week are listed below. Each week, pregnant women will be given a 15-minute meditation homework per day until the next week regarding the topic worked on. All meditations begin with relaxation and breathing exercises. In each meditation, the emotion and root-belief analysis related to the relevant topic will be done by the practitioner. With this application, it is aimed to accelerate the change in the mind with positive language and regular repetition.

group c experimental group

In the pregnancy school, an informational support training is provided to pregnant women and their families to ensure that the pre-pregnancy, pregnancy and birth process is passed in a healthy and conscious manner. The training content includes: Reproductive organs and development, Nutrition during pregnancy and puerperium, Common problems during pregnancy, Physiological changes, Non-formological methods, Breathing techniques during birth, Anesthetic methods, Birth methods and techniques, Postpartum and baby care, Newborn Care / Problems, Home-Bag-Hospital preparation, Breast milk - Its importance - Breastfeeding, Family planning topics are given five days a week for 2 hours.

Group B Pregnancy School

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18 and over, pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being primiparous pregnant.
  • Being between the ages of 18-50.
  • Being a high school graduate.
  • Not having vision or hearing problems.
  • Not having communication problems.
  • Not having a risky pregnancy.

You may not qualify if:

  • Not having a high school graduate.
  • Being a multiparous pregnant woman.
  • Having a vision or hearing problem.
  • Having a communication problem.
  • Being diagnosed with a risky pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk Uni

Erzurum, None Selected, 25240, Turkey (Türkiye)

Location

Study Officials

  • serap ejder apay

    ATATURK UNI.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd student

Study Record Dates

First Submitted

October 16, 2024

First Posted

November 7, 2024

Study Start

May 9, 2024

Primary Completion

November 10, 2024

Study Completion

December 31, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations