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

NCT07267351 | Completed

• 1 other identifier: EK 44/24
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy; Meditation; Midwifery Support; Labor Pain; Childbirth

Keywords

birth; labor pain; meditation; midwifery 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.

  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 Outcomes (2)

• The Impact of Antenatal ThetaHealing Meditation on Intrapartum Pain and Fear in Primiparous Women: A Randomized Controlled Trial

  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 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.

Study Arms (2)

Thetahealing Meditation Group

EXPERIMENTAL

Structured ThetaHealing Meditation Training in the Antenatal Period

Behavioral: ThetaHealing Meditation Method; Behavioral: Thetahealing Meditation

control group

NO INTERVENTION

Routine Hospital Childbirth Protocols

Interventions

ThetaHealing Meditation Method BEHAVIORAL

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.

Thetahealing Meditation Group

Thetahealing Meditation BEHAVIORAL

Content, Number of Sessions, and Duration of the Intervention

Thetahealing Meditation Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (2)

Lefkoşa Acil Durum Hastanesi

Nicosia, Cyprus

Location

Lefkoşa Dr. Burhan Nalbantoğlu State Hospital

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Research Assistant

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 5, 2025
• Study Start: May 15, 2025
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)