Effect of Laughter Therapy on Perceived Stress and Quality of Life

NCT ID: NCT05391373

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2022-06-12

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.

Detailed Description

This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of laughter therapy on perceived stress and quality of life in women with breast cancer.This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All patients were women with breast cancer who received a once-weekly Paclitaxel regimen.

Conditions

Laughter Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Laughter Therapy Group

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.

Group Type: EXPERIMENTAL

Laughter therapy

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laughter therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

Pinar Zorba Bahceli, PhD RN

Asistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir Bakircay University Health Sciences Faculty

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/271

Identifier Type: -

Identifier Source: org_study_id