The Laughter, Pregnancy, Anxiety and Llife Quality

NCT06556927 | Recruiting

• 1 other identifier: KırklareliAS-12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Life Style; Gestational Diabetes; Pregnancy Related

Keywords

Pregnancy; Gestational Diabetes; Laughter yoga

Outcome Measures

Primary Outcomes (3)

• Quality of Life Scale During Pregnancy

  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

  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

• Psychometric Properties of Eurohis (Whoqol-8.Tr) Turkish Version in Turkish Society

  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

Study Arms (2)

Laughter yoga group

EXPERIMENTAL

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.

Other: Laughter yoga

Control group

NO INTERVENTION

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.

Interventions

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.

Laughter yoga group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Kırklareli University

Kırklareli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Diabetes, Gestational

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• AYCA SOLT KIRCA, Phd

  Kırklareli University

  STUDY CHAIR

Central Study Contacts

remziye karadoğan, midwife

CONTACT

05539852662; remziyekaradogankosanoglu@gmail.com

AYCA SOLT KIRCA, Phd

CONTACT

05392684185; aycasolt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssociate professor

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: October 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)