NCT07267351

Brief Summary

Purpose: This randomized controlled study was designed to determine the effect of the ThetaHealing meditation method given to primiparous pregnant women during the antenatal period on labor pain and fear. Objectives:

  1. 1.To increase childbirth satisfaction by enabling pregnant women to use the ThetaHealing meditation method during labor.
  2. 2.To ensure the use of the ThetaHealing meditation method during labor in order to reduce labor pain and/or facilitate adaptation to pain.
  3. 3.To reduce childbirth fear and/or facilitate adaptation to childbirth fear during labor by using the ThetaHealing meditation method.
  4. 4.To improve childbirth comfort through the ThetaHealing meditation method and thereby encourage vaginal birth.
  5. 5.Labor pain and childbirth fear are important factors that affect pregnant women's birth preferences. Negative birth experiences heard from women's social environment create beliefs that their own births will also be difficult, bloody, and traumatic.
  6. 6.Teaching the ThetaHealing meditation method to pregnant women during the antenatal period and enabling them to use their minds positively during labor is thought to increase women's comfort at the time of birth.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress43%
Jun 2025Jul 2027

Study Start

First participant enrolled

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

November 20, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

birthlabor painmeditationmidwifery support

Outcome Measures

Primary Outcomes (1)

  • Determining the effect of the ThetaHealing meditation method given during the antenatal period on labor pain and childbirth fear in primiparous women.

    The period from the 20th week of pregnancy until the end of labor.

Study Arms (2)

experimental group

They are women who are between the 20th and 40th weeks of pregnancy, volunteer to participate in the study, have no systemic disease, are expected to have a normal vaginal birth, have not been diagnosed with a high-risk pregnancy, and have a singleton fetus.

Behavioral: ThetaHealing Meditation Method

Experimental Group

They are women who are between the 20th and 40th weeks of pregnancy, volunteer to participate in the study, have no systemic disease, are expected to have a normal vaginal birth, have not been diagnosed with a high-risk pregnancy, and have a singleton fetus.

Interventions

ThetaHealing is a meditation method discovered by Vianna Stibal in 1994. This method is practiced using the theta brain wave, which has a frequency range of 4-8 Hz. According to Stibal, during the meditation process the individual has the potential to heal spiritually, physically, and emotionally (Stibal, 2011). In belief work, it actually leads the person to question what they believe and where this belief originates from, and then teaches how to load positive feelings that reflect the person's own reality in place of this negative belief. The ThetaHealing method is a defined, systematic meditation technique that is divided into courses related to various areas of life and levels of progress (Loska A., 2023).

experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women who apply to the Obstetrics and Gynecology Outpatient Clinic and Inpatient Ward of Lefkoşa Dr. Burhan Nalbantoğlu State Hospital and agree to participate in the study.

You may qualify if:

  • A healthy pregnant woman aged between 18 and 35 years. The absence of any chronic disease. Having a single healthy fetus with a gestational age greater than 20 weeks. Willing to participate in the study. Having no systemic disease. Being in her first pregnancy.

You may not qualify if:

  • Those who do not complete the training. Not being in the 18-35 age range. Having a systemic disease. Having been diagnosed with a high-risk pregnancy. Having a multiple pregnancy. Being multiparous.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lefkoşa Dr. Burhan Nalbantoğlu State Hospital

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 5, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 5, 2025

Record last verified: 2025-06

Locations