Determining the Effect of the ThetaHealing Meditation Method Given During the Antenatal Period on Labor Pain and Fear in Primiparous Women

August 26, 2026 updated by: Aysenur Gezer, Near East University, Turkey
PurposeThis randomized controlled trial (RCT) aims to evaluate the effects of antenatal ThetaHealing meditation training on labor pain and childbirth fear among primiparous women.ObjectivesTo enhance childbirth satisfaction by enabling laboring women to utilize the ThetaHealing meditation technique during delivery.To assess the efficacy of ThetaHealing meditation in alleviating labor pain and fostering pain adaptation.To evaluate the impact of ThetaHealing meditation on reducing childbirth fear and enhancing psychological coping mechanisms during labor.To optimize intrapartum comfort via ThetaHealing meditation, thereby promoting spontaneous vaginal delivery.Background and HypothesesLabor pain and fear of childbirth (tokophobia) significantly influence maternal delivery preferences. Exposure to negative birth narratives often instills maladaptive beliefs, leading women to anticipate traumatic, high-risk birth outcomes. Implementing antenatal ThetaHealing meditation aims to cultivate positive cognitive reframing, thereby improving maternal comfort during labor.Furthermore, continuous midwifery support enhances maternal self-efficacy and emotional security, which directly impacts delivery outcomes. Although empirical literature regarding intrapartum electroencephalographic (EEG) activity remains limited, clinical observations suggest that routine hospital admissions-characterized by continuous electronic fetal monitoring (NST), bright lighting, and procedural interventions-predominantly induce beta-wave activity associated with heightened stress and anxiety. Transitioning to a low-stimulus environment with continuous midwifery care may facilitate a shift toward alpha brainwave activity ($8\text{--}12\text{ Hz}$), promoting relaxation. Under self-paced labor conditions, women may further transition into theta-wave activity ($4\text{--}8\text{ Hz}$), a state of heightened intuition, reduced distress, and somatic attunement.Given the lack of quantitative neurophysiological data during labor, this study utilizes EEG monitoring to track maternal brainwave frequencies during ThetaHealing meditation. By evaluating the method's efficacy in fostering alpha and theta frequencies, this research seeks to mitigate unnecessary cesarean deliveries, alleviate childbirth fear and pain, and address a key gap in the neuro-obstetric literature.Key Enhancements:Randomized controlled study $\rightarrow$ Randomized controlled trial (RCT): Standard medical abbreviation.Childbirth fear $\rightarrow$ Fear of childbirth (tokophobia): Incorporates accepted clinical terminology.Surrender $\rightarrow$ Somatic attunement / Psychological coping: Replaced the non-clinical concept of "surrender" with precise biobehavioral language suitable for medical journals.Brain wave $\rightarrow$ Brainwave frequency / EEG activity: Standard neurophysiological terms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial (RCT) aims to evaluate the efficacy of an antenatal ThetaHealing meditation program in alleviating labor pain and fear of childbirth among primiparous women. The intervention protocol for the study group is structured across three distinct phases.Phase I: Antenatal Training and Baseline AssessmentParticipant recruitment, informed voluntary consent, and baseline data collection-comprising the Antenatal Information Form and the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A)-will be conducted by the primary researcher. Intervention participants will undergo a structured four-week antenatal educational program at the Obstetrics and Gynecology Department of Nicosia Emergency Hospital. The curriculum totals 8 hours of instruction (administered in weekly 2-hour sessions) utilizing multimodal instructional tools, including video modules, visual aids, interactive discussions, and supervised practical demonstrations. Upon completion, participants will receive a certificate of completion and a study-specific identification wristband to ensure protocol adherence upon hospital admission.Phase II: Intrapartum Intervention, EEG Monitoring, and Data CollectionParticipants will notify the researcher at the onset of active labor and will be managed in accordance with the hospital's standard vaginal delivery protocols. In addition to continuous one-on-one midwifery support, the researcher will guide intervention participants through taught breathing, visualization, and ThetaHealing meditation techniques.To assess neurophysiological shifts and analgesic efficacy across labor progression, parameters will be evaluated at three predetermined cervical dilation stages ($3\text{--}4\text{ cm}$, $5\text{--}6\text{ cm}$, and $7\text{--}8\text{ cm}$):Intervention Group: Visual Analog Scale (VAS) pain scores will be recorded immediately prior to and following a 20-minute ThetaHealing meditation session. Continuous electroencephalogram (EEG) recordings will be acquired during the 20-minute intervention to capture real-time brainwave frequency shifts.Control Group: Participants will receive standard intrapartum care without meditation instruction. EEG recordings and VAS pain assessments will be obtained at matching cervical dilation intervals ($3\text{--}4\text{ cm}$, $5\text{--}6\text{ cm}$, and $7\text{--}8\text{ cm}$) to document baseline neurophysiological frequency states during labor without intervention.Phase III: Postpartum EvaluationApproximately two hours postpartum, the primary researcher will collect post-intervention outcomes via face-to-face interviews and clinical observations using the Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ B) and the Postpartum Evaluation Form across both groups.Overview of Study DesignPhaseTimelineIntervention GroupControl GroupKey Outcome MeasuresPhase IAntenatal (4-Week Program)8-hour structured ThetaHealing course + Baseline assessmentBaseline assessment only (No training)W-DEQ Version A, Antenatal Information FormPhase IIIntrapartum ($3\text{--}4\text{ cm}$, $5\text{--}6\text{ cm}$, $7\text{--}8\text{ cm}$ Dilation)Guided 20-min meditation + Continuous midwifery careStandard intrapartum delivery room carePre/Post VAS Pain Scores, Real-time EEG Frequency TrackingPhase IIIPostpartum (~2 Hours Post-Delivery)Postpartum interview & clinical observationPostpartum interview & clinical observationW-DEQ Version B, Postpartum Evaluation FormKey Improvements Made:Structure & Readability: Consolidated redundant descriptions into a clear three-phase chronological narrative supported by a comparison table.Clinical Precision: Updated informal phrasing (e.g., "when cervical dilation is 3-4 cm") to standardized clinical syntax ($3\text{--}4\text{ cm}$ cervical dilation).Objective Tone: Standardized methodology terminology (e.g., EEG data acquisition, neurophysiological frequency shifts, analgesic efficacy).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Lefkoşa Dr. Burhan Nalbantoğlu State Hospital
      • Nicosia, Cyprus
        • Lefkoşa Acil Durum Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

To be eligible for the study,

  • participants had to be primiparous women
  • aged 18 to 35 years with a healthy,
  • singleton pregnancy at a gestational age greater than 20 weeks,
  • free of chronic or systemic diseases, and
  • willing to provide informed consent. Exclusion criteria comprised
  • multiparity,
  • age outside the 18-35 range,
  • multiple gestations,
  • high-risk pregnancy diagnoses,
  • pre-existing systemic conditions, or failure to complete the required training protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thetahealing Meditation Group
Structured ThetaHealing Meditation Training in the Antenatal Period
Behavioral: ThetaHealing Meditation Method
ThetaHealing is a structured meditation technique developed by Vianna Stibal in 1994. The method utilizes theta brainwave activity, which operates within a frequency range of 4-8 Hz. According to Stibal, the meditative state facilitates spiritual, physical, and emotional healing. Within its core framework of "belief work," the technique encourages individuals to examine the origin of their core beliefs, replacing negative cognitive patterns with positive attributes aligned with their lived reality. Furthermore, ThetaHealing represents a systematic, standardized meditation approach structured across sequential modules corresponding to distinct life domains and developmental stages.
Behavioral: Thetahealing Meditation
Content, Number of Sessions, and Duration of the Intervention
No Intervention: control group
Routine Hospital Childbirth Protocols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determining the effect of the ThetaHealing meditation method given during the antenatal period on labor pain and childbirth fear in primiparous women.
Time Frame: The period from the 20th week of pregnancy until the end of labor.
Phase-Specific Visual Analog Scale (VAS) Pain Score. The Visual Analog Scale (VAS) is a pain scale numbered from 0 to 10. The left end of the line represents "no pain" (0), while the right end represents "unbearable, worst possible pain" (10).
The period from the 20th week of pregnancy until the end of labor.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Impact of Antenatal ThetaHealing Meditation on Intrapartum Pain and Fear in Primiparous Women: A Randomized Controlled Trial
Time Frame: The study observation period spans from the 20th week of gestation through the completion of childbirth. Throughout this timeframe, biological, psychological, and intrapartum clinical parameters are continuously monitored to assess longitudinal maternal-
The primary outcome variables of this study comprise psychometric measures, clinical obstetric parameters, intrapartum interventions, and maternal-neonatal bonding indicators. Childbirth fear and psychological expectations/experiences will be evaluated using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ, Versions A and B) scores, alongside postpartum ratings of perceived childbirth difficulty. Obstetric progress will be quantified by the duration of cervical dilation (first stage of labor), the duration of the second stage, and the duration of the third stage of labor. Clinical intrapartum parameters include the mode of delivery (spontaneous vaginal, operative vaginal, or cesarean section), the necessity of labor induction, and the utilization of epidural analgesia. Furthermore, neonatal and maternal-infant interaction outcomes will be assessed through the requirement for Neonatal Intensive Care Unit (NICU) admission or special care, the implementation of early skin-to
The study observation period spans from the 20th week of gestation through the completion of childbirth. Throughout this timeframe, biological, psychological, and intrapartum clinical parameters are continuously monitored to assess longitudinal maternal-
Determining the effect of the ThetaHealing meditation method given during the antenatal period on labor pain and childbirth fear in primiparous women.
Time Frame: The study observation period spans from the 20th week of gestation through the completion of childbirth. Throughout this timeframe, biological, psychological, and intrapartum clinical parameters are continuously monitored to assess longitudinal maternal.
The primary outcome variables of this study comprise psychometric measures, clinical obstetric parameters, intrapartum interventions, and maternal-neonatal bonding indicators. Childbirth fear and psychological expectations/experiences will be evaluated using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ, Versions A and B) scores, alongside postpartum ratings of perceived childbirth difficulty. Obstetric progress will be quantified by the duration of cervical dilation (first stage of labor), the duration of the second stage, and the duration of the third stage of labor. Clinical intrapartum parameters include the mode of delivery (spontaneous vaginal, operative vaginal, or cesarean section), the necessity of labor induction, and the utilization of epidural analgesia. Furthermore, neonatal and maternal-infant interaction outcomes will be assessed through the requirement for Neonatal Intensive Care Unit (NICU) admission or special care, the implementation of early skin-to
The study observation period spans from the 20th week of gestation through the completion of childbirth. Throughout this timeframe, biological, psychological, and intrapartum clinical parameters are continuously monitored to assess longitudinal maternal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Near East University, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK 44/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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