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PregnancyNCT07267351

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

A study testing ThetaHealing Meditation Method and Thetahealing Meditation in people with Pregnancy and Meditation, run by Near East University, Turkey at 2 sites in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Pregnancy, Meditation, Midwifery Support
What is being tested?
ThetaHealing Meditation Method and Thetahealing Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
2 sitesCyprus
Study dates
15 May 2025to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

2 sites in 1 country.

Cyprus2 sites
  • Lefkoşa Acil Durum Hastanesi

    Nicosia

  • Lefkoşa Dr. Burhan Nalbantoğlu State Hospital

    Nicosia

Other trials in Cyprus

About this study

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.

Read the 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).

Being tested
ThetaHealing Meditation Method, Thetahealing Meditation
Keywords
birth, labor pain, meditation, midwifery support
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThetaHealing Meditation MethodBehavioural

    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 MeditationBehavioural

    Content, Number of Sessions, and Duration of the Intervention

Study groups in NCT07267351
Study groupRoleWhat they receive
Thetahealing Meditation GroupExperimentalStructured ThetaHealing Meditation Training in the Antenatal Period
Receives: Behavioral: ThetaHealing Meditation Method; Behavioral: Thetahealing Meditation
control groupNo interventionRoutine Hospital Childbirth Protocols

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)
  1. 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

    Measured: 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-

  2. 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start15 May 2025
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07267351
Sponsor's protocol ID
EK 44/24
Status last verified
Aug 2026
First submitted
20 Nov 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ThetaHealing Meditation Method and Thetahealing Meditation in people with Pregnancy and Meditation, run by Near East University, Turkey at 2 sites in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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Clinical Trial NCT07267351 | AzTrials