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Completed

NCT Number: NCT05391373

Effect of Laughter Therapy on Perceived Stress and Quality of Life

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.

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Key information

Conditions

Laughter Therapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bakircay University Health Sciences Faculty

Izmir, 35560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Perceived Stress Scale

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

    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.

Secondary outcomes

  1. Quality of Life Scale (SF-12)

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

    The scale evaluates the quality of life of individuals.The scale consists of 12 items and two sub-dimensions in total.While the items related to physical and emotional role were answered as yes or no, the other items had likert type options ranging between 3 and 6. While the Physical Component Summary-12 (PCS-12) score was obtained from the sub-dimensions of general health, physical functionality, physical role and body pain; The Mental Component Summary-12 (MCS-12) score was obtained from the sub-dimensions of social functionality, emotional role, mental health and energy. Both the PCS-12 and MCS-12 scores range from 0 to 100, with the higher score representing better health.Soylu et al. performed the validity and reliability study of the Turkish version of Quality of Life Scale (SF-12) and the internal consistency of the scale was determined to be 0.73.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

Effect of Laughter Therapy on Perceived Stress and Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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