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NCT Number: NCT06556927

The Laughter, Pregnancy, Anxiety and Llife Quality

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.

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Key information

Conditions

Anxiety Anxiety Disorders Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Life Style Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy Related Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli University

Kırklareli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laughter yoga

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Registry information

Official study title

Effect of Laughter Yoga on Stress and Quality of Life in Pregnant Women With Gestational Diabetes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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