The Effect of Laughter Yoga Practice in Hypertension Patients

NCT07148869 | Not Yet Recruiting DMC

• 1 other identifier: HASAN KALYONCU UNIVERSITY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HT), which is defined as an arterial blood pressure higher than 140/90 mmHg, is an important health problem because it causes serious complications and is commonly seen in the community. Laughter as an expression of humour has been accepted as a good medicine for centuries. It is also one of the practices used in nursing care according to the Nursing Interventions Classification (NIC). Laughter yoga developed by Dr. Madan Kataria, an Indian medical doctor, in 1995 includes deep breathing exercises, meditation, childish games and laughter without humour. In practice, individual sessions as well as group sessions can be held. It is important to form groups of at least 5 people in terms of the dynamics of the group. The first stage in laughter yoga is warm-up exercises. Hands are clapped parallel to each other, acupuncture points are stimulated by stimulating the fingertips and palms as clapping is performed, and a vocal rhythm in the form of ho, ho, ha-ha-ha is added to the last clapping movement. In the second stage, breathing exercises, the participants raise their arms to the sky as if praying, inhale and hold their breath for 4-5 seconds after deep inspiration and exhale rhythmically and slowly. The third stage includes childish games. The last stage is the stage of laughter exercises in which unreasonable laughter is thrown by imagining situations as if they did not exist. These exercises include milkshake laughter exercises, lion laughter, hot soup laughter, hugging laughter, bird laughter, etc. It is recommended that each session should be at least 20 minutes and should be applied for at least 8 weeks. At the end of the session, individuals are provided to relax by meditation. The aim of this thesis study;

• Developing the Laughter Yoga Satisfaction Scale and
• To investigate the effect of laughter yoga practice on anxiety, sleep quality, treatment compliance and satisfaction in hypertension patients. Hypotheses of the study H1-1: Laughter Yoga Satisfaction Scale is a valid scale. H2-1: Laughter Yoga Satisfaction Scale is a reliable scale. H3-1: Laughter yoga reduces the anxiety level of hypertension patients. H4-1: Laughter yoga improves the sleep quality of hypertension patients. H5-1: Laughter yoga increases the level of compliance with treatment in hypertension patients. H6-1: Hypertension patients have a high level of satisfaction with laughter yoga. H7-1: Laughter yoga has positive effects on vital signs of hypertension patients.

Conditions

Hypertension; Laughter Yoga

Keywords

Hypertension; Sleep Quality; laughter yoga; anxiety; treatment compliance

Outcome Measures

Primary Outcomes (5)

• Life Findings Record Form

  The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form.

  Day 1

• Sleep Quality

  Pittsburgh Sleep Quality Index (PSQI): The Turkish validity and reliability of the scale developed by Buysse et al. to evaluate sleep quality in the last month was performed by Ağargün et al. The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score \>5 indicates 'poor sleep quality' and a PDQI total score \<5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80.

  Day 1

• State and Trait Anxiety Inventory

  State and Trait Anxiety Inventory (STAI): The scale developed by Spielberger et al. (1970) was adapted to Turkish culture and validity and reliability studies were conducted by Öner and Le Compte (1983). The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (incre

  Day 1

• Hill-Bone Hypertension Treatment Compliance

  Hill-Bone Hypertension Treatment Compliance Scale: The Turkish validity and reliability of the scale developed by Kim et al. was performed by Karademir et al. The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.

  Day 1

• Laughter Yoga Satisfaction

  Laughter Yoga Satisfaction Scale: In the first phase of the study, the scale developed by the researcher and the validity-reliability study will be used. On a scale ranging from a minimum of 13 to a maximum of 65, it is shown that satisfaction increases as the score increases.

  Day 4

Secondary Outcomes (5)

• Sleep Quality

  four weeks later

• State and Trait Anxiety Inventory

  four weeks later

• Hill-Bone Hypertension Treatment Compliance

  four weeks later

• Laughter Yoga Satisfaction

  four weeks later

• Life Findings Record Form

  up to 4 weeks

Study Arms (2)

laughter yoga group

EXPERIMENTAL

Patients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.

Behavioral: LAUGHTER YOGA

CONTROL GROUP

PLACEBO COMPARATOR

there will be no application to this group

Other: control group

Interventions

LAUGHTER YOGA BEHAVIORAL

Patients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.

laughter yoga group

control group OTHER

there will be no application to this group

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with hypertension in the last one year
• Those who volunteered to participate in the study
• No problem preventing communication
• No cognitive and mental problems
• Not taking anxiolytics, antidepressants or sleeping pills
• Individuals without an additional chronic disease that may affect breathing, such as heart failure or chronic obstructive pulmonary disease
• Will be included in the research.

You may not qualify if:

• The patient wishes to leave the study voluntarily
• Less than 80% participation of the patient in the laughter yoga programme
• Failure of the patient to participate in follow-up assessments
• The patient receives additional treatments during the study

Sponsors & Collaborators

• Kilis 7 Aralik University: lead
• Hasan Kalyoncu University: collaborator

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Patient Compliance

Interventions

Laughter Therapy; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• NURAN TOSUN, PROF.

  STUDY DIRECTOR

Central Study Contacts

GULSEN KARATAS

CONTACT

+905054846160; glsnkrts002@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 2 group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 29, 2025
• Study Start: August 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: December 31, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)