- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06556927
The Laughter, Pregnancy, Anxiety and Llife Quality
Effect of Laughter Yoga on Stress and Quality of Life in Pregnant Women With Gestational Diabetes
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
The American College of Obstetricians and Gynecologists (ACOG) defines GDM as "abnormal glucose tolerance that begins in pregnancy or is first diagnosed during pregnancy." However, the American Diabetes Association (ADA) and the World Health Organization (WHO) want to distinguish cases with possible diabetes diagnosed before pregnancy and diagnosed during pregnancy from glucose intolerance that occurs as a result of pregnancy and is related to pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. Laughter yoga is a non-pharmacological and non-invasive alternative treatment method. Laughter yoga is a type of communication that combines pleasant emotions, smiles, and laughter. It is a different approach from medical treatments; indicates that the psychological aspects of the brain must change in order for both the mind and body to be healthy. Maternal complications increase in pregnant women diagnosed with gestational diabetes. The prospective psychological concerns experienced by the pregnant woman (low risk, preterm birth, low birth weight) negatively affect the quality of life of the pregnant woman. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: remziye karadoğan, midwife
- Phone Number: 05539852662
- Email: remziyekaradogankosanoglu@gmail.com
Study Contact Backup
- Name: AYCA SOLT KIRCA, Phd
- Phone Number: 05392684185
- Email: aycasolt@hotmail.com
Study Locations
-
-
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Kırklareli, Turkey
- Recruiting
- Kırklareli University
-
Contact:
- AYCA SOLT KIRCA, Phd
- Phone Number: 05392684185
- Email: aycasolt@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Answering the survey and scale forms completely
- Being 18 years of age or older
- Being able to read and understand Turkish
- Not having any physical or mental problems that would prevent communication
- Pregnant women diagnosed with gestational diabetes
- Being in social media accounts and WhatsApp groups
- Scoring 35 and above on the STAI scale
- Scoring 37 and above on the quality of life scale during pregnancy
Exclusion Criteria:
- Not volunteering to participate in the study
- Incomplete responses to surveys and scales
- Being under the age of 18
- Not understanding Turkish
- Having any physical or mental problems that would prevent communication
- Pregnant women who have not been diagnosed with gestational diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter yoga group
Laughter yoga will be performed in 8 sessions, 2 days a week for 4 weeks.
The duration of each session will be 40 minutes.
Laughter yoga sessions will be held on a day suitable for all participants and with the participation of at least 8 people.
The session will start with warm-up exercises and continue with laughter exercises.
People in the group will do these exercises with the guidance of the researcher.
|
Part 1: Deep Breathing Exercises: Raise the arms up towards the sky and take a deep breath as possible and hold the breath for 4-5 seconds. This application is repeated several times. This section takes approximately 5-10 minutes. Part 2: Warm-up exercises: Hands are kept parallel to each other and clapped. The tips of the fingers and palms touch each other, the acupuncture points on both hands are stimulated and the individual's energy level increases. Section 3: Childish Games: In this section there are childish games. These games are visualized in the mind and the participants are asked to raise their arms upwards in the shape of the letter "Y".This section takes approximately 10 minutes. Section 4: Laughter Exercises: Participants are given verbal guidance such as "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, let's make a wish or pray" and the laughter exercise is terminated. This section takes approximately 15 minutes. |
|
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 and increase life quality. The researcher will ask the participants via phone 4 times a week for 1 month whether they have taken any action to reduce their anxiety and increase life quality symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety and increase life quality symptoms will be excluded from the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Scale During Pregnancy
Time Frame: between 2 to 4 weeks
|
It aims to optimally evaluate the quality of life of women with normal pregnancies and consists of nine items.
It is a scale specific to singleton pregnancies that should be used in clinical and social research because it provides a better perspective on the quality of life of pregnant women rather than a general quality of life scale.
The total score of the scale varies between 9-45, with higher scores indicating higher quality of life.There is no adverse substance in the scale.
It can be used in every trimester
|
between 2 to 4 weeks
|
|
State-Trait Anxiety Inventory
Time Frame: between 2 to 4 weeks
|
The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively.
Higher scores are associated with more anxiety.
|
between 2 to 4 weeks
|
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Psychometric Properties of Eurohis (Whoqol-8.Tr) Turkish Version in Turkish Society
Time Frame: between 2 to 4 weeks
|
EUROHIS-QOL 8 was developed by the World Health Organization (WHO) in 2003.
It consists of 8 items and was validated in Turkish by Eser et al in 2010.
The total score determines the overall quality of life level; higher scores indicate higher quality of life
|
between 2 to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: AYCA SOLT KIRCA, Phd, Kırklareli University
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
- KırklareliAS-12
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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