- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267351
Determining the Effect of the ThetaHealing Meditation Method Given During the Antenatal Period on Labor Pain and Fear in Primiparous Women
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:
- To increase childbirth satisfaction by enabling pregnant women to use the ThetaHealing meditation method during labor.
- To ensure the use of the ThetaHealing meditation method during labor in order to reduce labor pain and/or facilitate adaptation to pain.
- To reduce childbirth fear and/or facilitate adaptation to childbirth fear during labor by using the ThetaHealing meditation method.
- To improve childbirth comfort through the ThetaHealing meditation method and thereby encourage vaginal birth.
- 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.
- 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.
In addition, continuous midwifery care during labor is known to increase a woman's self-confidence. A woman's feeling well and safe will influence the mode of birth. There is no research in the literature specifically addressing brain waves and childbirth. However, based on information conveyed by healthcare professionals, it is thought that after the procedural processes that begin when a woman is admitted to the hospital for birth, pregnant women remain in the beta frequency together with stress and anxiety. This is because the beta frequency is a brain wave in which surrender cannot be achieved and the person experiences intense stress and anxiety. It is clear that a woman cannot reach a state of surrender while feeling anxiety and worry under bright hospital lights in a room filled with NST sounds. With the progression of labor, a calmer environment, dim lighting, and continuous midwifery support, it is thought that the pregnant woman can reach the alpha brain wave and become ready for surrender.It is even thought that if the progression of labor is left to the woman's control, she may reach the theta brain wave. A woman who can reach the alpha or theta brain wave is awake but in a continuous sleep-like state. She is now away from anxiety and stress, intuitive, instinctive, and attuned to the labor process. Since there is no scientific study on the effect of brain frequencies on the labor process, brain wave activity during labor has been inferred based on midwives' observations. By providing education on the ThetaHealing meditation method to pregnant women in the antenatal period, it is aimed to help women attune to the alpha and/or theta frequency, thereby reducing the increase in cesarean rates and facilitating adaptation to childbirth fear and pain. For these purposes, an EEG device is needed to determine in which frequency range the brain waves are during labor when the ThetaHealing meditation method is used. By investigating the effectiveness of the training using an EEG device, a contribution will be made to the literature.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Nicosia, Cyprus
- Lefkoşa Dr. Burhan Nalbantoğlu State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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The period from the 20th week of pregnancy until the end of labor.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 44/24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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