Laughter Therapy Application in Hemodialysis Patients

NCT05576701 | Completed

• 1 other identifier: BBal
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Background: A randomized controlled study was conducted on the effects of laughter therapy on increasing the acceptance of the disease, compliance with treatment and comfort levels in patients receiving hemodialysis treatment. Materials and methods: The study was conducted with 42 (experimental group=21, control group=21) patients treated in the hemodialysis unit. Eight sessions of laughter yoga were applied to the hemodialysis patients in the experimental group for four weeks, two days a week. Data were used on the Patient Information Form, the Acceptance Scale, the End Stage Renal Failure - Compliance Scale, and the Hemodialysis Comfort Scale.

Conditions

Comfort; Acceptance Processes; Hemolysis; Laughter Therapy; Treatment Adherence; Patients

Outcome Measures

Primary Outcomes (1)

• Change in Disease Acceptance Level

  This form was used to measure the degree of acceptance of the disease in hemodialysis patients. In the research, it was applied twice in total before the laughter therapy was applied and after the laughter therapy was finished. The total score to be obtained from the scale varies between 8 and 40, and as the score increases, the level of acceptance of the disease increases.

  4 weeks

Secondary Outcomes (1)

• Change in compliance level in end-stage renal disease

  4 weeks

Other Outcomes (1)

• Change in comfort level in hemodialysis patients

  4 weeks

Study Arms (2)

Laughter Therapy

EXPERIMENTAL

Laughter therapy consists of group-based interventions that include yoga breathing exercises and stillness. Laughter education is a form of exercise with gratuitous laughter and childlike play. Laughter therapy practices consist of four steps. These; warming exercises, deep exercises, playing childlike games and entertainment (eg greeting laughter, lion laughter, milk waving sounds, quiet laughter, etc.). Laughter therapy sessions in the study were carried out for 4 weeks and three times a week. Laughter therapy has been applied by researchers who have a leader certificate.

Behavioral: Laughter Therapy

Control

ACTIVE COMPARATOR

The patients in the control group, on the other hand, did not undergo any intervention other than their routine treatment and care. The patients were followed for four weeks. Before the study, data collection tools were applied to the patients. Again, after the study started and the study ended, all other data collection tools were applied, except the "Patient Information Form".

Other: Control

Interventions

Laughter Therapy BEHAVIORAL

In this study, laughter therapy was applied to the experimental group three times a week (on Mondays, Wednesdays, and Fridays) for a total of 12 sessions. Each session started with other patients in the HD unit while the patient was receiving HD treatment (1 hour after HD started) and lasted 30-45 minutes. The number of patients who will take part in each laughter session is based on the number of patients attending that session in the hemodialysis unit.

Laughter Therapy

Control OTHER

The patients in the control group, on the other hand, did not undergo any intervention other than their routine treatment and care. Laughter therapy was applied for four weeks to HD patients in the control group who wanted the results of the research.

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been treated for HD for more than six months,
• who are over 18 years old
• who agree to participate in the study

You may not qualify if:

• patients with severe cardiovascular disease,
• who are pregnant,
• with psychiatric disorders,
• who do not regularly attend laughter therapy sessions,
• who have experience in laughter therapy

Sponsors & Collaborators

• Bozok University: lead

Study Sites (2)

Betül

Yozgat, Akdağmadeni, Turkey (Türkiye)

Location

Betül

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior; Hemolysis; Treatment Adherence and Compliance

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: While the patients were randomized; In order to keep the possibility of being affected by each other at a minimum level, the work was continued with the same application group in the same session group. 72 days in universe, hemodialysis days and sessions at time of day, next Wednesday, Friday = 36 patients); Tuesday, Thursday, evening patient control (n=36 patients are guided by the drawing method.

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: October 12, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

TU (2)