- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449013
The Effect Of Laughter Yoga and Emotional Freedom Technique on Anxiety in Pregnant Women
The Effect Of Laughter Yoga and Emotional Freedom Technique on Anxiety in Pregnant Women: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Pregnancy is a process that involves not only physical changes to the body but also profound and continuous emotional and psychological changes. Hormonal fluctuations, bodily changes, cultural norms, and the responsibilities that come with motherhood can cause anxiety in pregnant women. A systematic review and meta-analysis conducted to determine anxiety experienced during pregnancy found that the prevalence of anxiety was 22%. In a study conducted in Turkey, it was reported that 32% of pregnant women experienced anxiety during pregnancy. When looking at the effects of anxiety during pregnancy on the mother and baby, it is seen that there are many negative effects, ranging from low birth weight to an increased risk of postpartum depression. Therefore, methods for coping with anxiety become important at this point.
Laughter yoga and the emotional freedom technique(EFT) are effective methods for reducing anxiety. Laughter yoga is an exercise programme that combines unconditional laughter with yoga breathing (Pranayama) techniques. It lowers stress hormone levels and stimulates the release of endorphins, making the person feel good. The emotional freedom technique is an energy technique based on the idea that 'the source of negative emotions is disturbances in the body's energy system.' It provides relaxation by balancing the person's energy fields. A review of the literature reveals that no studies have been conducted on the effects of laughter yoga and the emotional freedom technique on anxiety during pregnancy.This research was planned to determine the effect of laughter yoga and the emotional freedom technique applied to pregnant women on anxiety.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Centre
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Kırklareli, Centre, Turkey (Türkiye), 39000
- Kırklareli Healthy Life Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For the laughter yoga group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga.
- For the emotional freedom technique(EFT) group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, have not previously undergone EFT, and have no infections, wounds, scars, etc. in the tapping areas where EFT will be applied.
- For the control group: Pregnant women who volunteered to participate in the study, can read and understand Turkish, are aged 18 or over, scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga or EFT.
Exclusion Criteria:
- For the laughter yoga group: Those wishing to continue working, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), those with psychiatric illnesses and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), those with any issues that prevent communication (such as impaired hearing, speech, or comprehension), those using pharmacological or non-pharmacological methods to reduce anxiety, those who have undergone abdominal surgery in the last three months, and pregnant women with glaucoma, hernia, epilepsy, bleeding haemorrhoids, or heart disease.
- For the EFT and control group: Those who do not wish to continue the study, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), Those with psychiatric disorders and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), Those with any condition that impedes communication (such as impaired hearing, speech, or comprehension), Pregnant women using either pharmacological or non-pharmacological methods to reduce anxiety.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group
Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.
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Experimental: Laughter yoga group
Laughter yoga will be applied to pregnant women with anxiety during pregnancy.
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Pregnant women in the laughter yoga group will undergo a total of six sessions over two weeks, three times a week, with each session lasting an average of 40-50 minutes.
The laughter yoga programme consists of the following: hand clapping and warm-up exercises, deep breathing exercises, childlike games, laughter exercises and laughter meditation.
Other Names:
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Experimental: Emotional freedom technique(EFT) group
Emotional freedom technique will be applied to pregnant women with anxiety during pregnancy.
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Pregnant women in the emotional freedom technique group will undergo a total of six sessions over two weeks, three times a week, with each session lasting an average of 40-50 minutes.The emotional freedom technique application consists of the following sections: Identifying the Problem, Grading the Problem, Creating the Setup Phrase, Applying Tapping, Evaluating the Result.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Trait Anxiety Inventory (STAI) scale
Time Frame: between six to twelve months
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This scale, developed by Spielberg in 1973, consists of 20 questions.
It is a 4-point Likert type scale (1=not at all, 4=very much).
The lowest score that can be obtained from the scale is 20, and the highest score is 80.
The higher the score is, the higher the anxiety level is.
The alpha value of the scale is 0.86-.92.33.
The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between.
The scale that will be used to evaluate the state and trait anxiety of pregnant women.
As the score increases, it is determined that the anxiety is higher.
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between six to twelve months
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Introductory Information Form
Time Frame: between six to twelve months
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A form that includes questions about women's socio-demographic and pregnancy and characteristics.
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between six to twelve months
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Pregnancy-related anxiety scale(PrAS)
Time Frame: between six to twelve months
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This scale was originally developed by Brunton, and its Turkish validity and reliability were established by Solt and Gul.
It is used to evaluate pregnancy-related anxiety.
Higher total scores, as well as higher scores across its nine subscales, indicate greater levels of anxiety in pregnant women.It will be used to assess pregnancy-related anxiety.
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between six to twelve months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Efsun Derin, Kırklareli University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KırklareliED-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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