Clinical trial NCT06678087: Meditation for Preparation for Birth and Motherhood Given with Thetahealing Meditation Method
Official title: The Effect of Birth and Motherhood Preparation Meditation Given with Thetahealing Meditation Method on Fear of Birth, Normal Birth Belief and Self-Efficacy and Normal Birth Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meditation
Fear of Labor
Thetahealing Meditation
Keywords: Brain
birth
Fear of Birth
Preparation for Birth
Pregnancy Education
EEG
Brain Waves
Meditation
Complementary and Alternative Medicine
ThetaHealing
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The study consists of a total of 3 groups, namely the control group (A) and the experimental groups (B, C).

* Group A is the group that receives routine hospital and midwifery care,
* Group B is the group that receives birth preparation training at the hospital's pregnancy school in addition to routine care,
* Group C is the group that receives birth preparation training at the hospital's pregnancy school in addition to routine care and is additionally applied to birth and motherhood preparation meditation created with theta-healing method.

The trainings at the Ankara City Hospital Gynecology and Obstetrics Department Pregnancy School are held every weekday at 10:00 and 12:00 and continue as a weekly program.

The contact information of all participants will be collected at the beginning so that contact can be made and planning can be made in the later stages of the study.

After the groups are formed, the researcher will collect the personal information form, the Prenatal Self-Assessment Scale Fear of Birth Sub-Dimension Scale, Self-Efficacy Scale for Normal Birth and the Belief in Normal Birth Scale and pre-test data for all groups.

Then, all groups will watch a 6-minute birth video containing various birth images while simultaneously recording their brain waves with a mobile EEG device.

In the 2nd step of the study (intervention step), while Group C continues to receive birth preparation training at the pregnancy school, the birth and motherhood preparation meditation study prepared with the theta-healing meditation method will be carried out by the researcher who is a theta-healing practitioner who has received training on this subject.

At the end of the Birth Preparation Training and Meditation study given at the pregnancy school, the experimental (B, C) and control (A) groups will be shown the birth video used at the beginning of the study for 6 minutes, as in the beginning of the study, and during this time, their brain activities will be recorded for the second time with the mobile EEG device. Then, post-test data will be collected again with the Prenatal Self-Assessment Scale Fear of Birth Sub-Dimension Scale, Self-Efficacy Scale for Normal Birth and Normal Birth Belief Scale.

Later, all pregnant women included in the study will notify the researcher at the beginning of labor and their brain activity will be recorded for 6 minutes with a mobile EEG device during labor. Finally, it is aimed to determine the level of fear experienced during and after labor by using the Wijma Birth Expectation/Experience Scale (W-DEQ) between the 1st and 10th day after labor.

Eligibility criteria: Inclusion Criteria:

1. Being primiparous pregnant.
2. Being between the ages of 18-50.
3. Being a high school graduate.
4. Not having vision or hearing problems.
5. Not having communication problems.
6. Not having a risky pregnancy.

Exclusion Criteria:

1. Not having a high school graduate.
2. Being a multiparous pregnant woman.
3. Having a vision or hearing problem.
4. Having a communication problem.
5. Being diagnosed with a risky pregnancy.

Primary outcomes:
measure: Prenatal Self-Assessment Scale- Fear of Birth Sub-Dimensions Description
timeFrame: 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.
measure: Normal Birth Belief Scale (NBS)
timeFrame: 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.
measure: Self-Efficacy Scale for Normal Birth
timeFrame: 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.
measure: Wijma Childbirth Expectation/Experience Scale (W-DEQ) Version B
timeFrame: Measurement between 1-10 days after birth for all groups will be taken.
measure: Brain Wave Measurement with Mobile EEG Device
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Uni
state: None Selected
Study officials:
affiliation: ATATURK UNI.
name: serap ejder apay
role: PRINCIPAL_INVESTIGATOR
References: