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

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: Completed
• Conditions: Pregnancy; Labor Pain; Meditation; Childbirth; Midwifery Support
• Intervention / Treatment: Behavioral: ThetaHealing Meditation Method; Behavioral: Thetahealing Meditation

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: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

Outcome Measure	Measure Description	Time Frame
The Impact of Antenatal ThetaHealing Meditation on Intrapartum Pain and Fear in Primiparous Women: A Randomized Controlled Trial	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.	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

• Sponsor: Near East University, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): May 15, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: meditation; birth; labor pain; midwifery support
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain
• Other Study ID 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