Effect of Laughter Therapy on Perceived Stress and Quality of Life

NCT05391373 | Completed

• 1 other identifier: 2021/271
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.

Conditions

Laughter Therapy

Keywords

Perceived stress; Quality of life; Laughter therapy; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale

  The scale consists of 14 items in total and was designed to measure how stressful the changing situations in the individual's life are perceived.The scale is a 5-point Likert-type scale with each item ranging from "never (0)" to "very often (4)". 7 of the scale items with positive expressions are scored in reverse and the total score that can be obtained from the scale ranges from 0 to 56. Eskin et al. performed the validity and reliability study of the Turkish version of Perceived Stress Scale and the internal consistency of the scale was determined to be 0.82.

  The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.

Secondary Outcomes (1)

• Quality of Life Scale (SF-12)

  The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.

Study Arms (2)

Laughter Therapy Group

EXPERIMENTAL

The women with breast cancer in the intervention group received two sessions of laughter therapy per week for eight weeks.Each laughter therapy session lasted 40 minutes.

Behavioral: Laughter therapy

Control group

NO INTERVENTION

The control group did not receive any intervention during the study period.

Interventions

Laughter therapy BEHAVIORAL

Each session started with a 10-minute breathing exercise accompanied by relaxing music, followed by 20-minute laughing exercises. Afterwards, the session was ended with a 10-minute meditation accompanied by relaxing music.

Laughter Therapy Group

Eligibility Criteria

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

You may qualify if:

• years and older women,
• Stages II or III breast cancer
• Receiving Pacitaxel chemotherapy regimen per a week

You may not qualify if:

• Using any complementary and alternative (CAM) treatment method during practice
• Having psychological diseases

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Health Sciences Faculty

Izmir, 35560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: May 21, 2022
• First Posted: May 25, 2022
• Study Start: February 17, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 12, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)