RecruitingNot ApplicableNCT06116812

The Effects of Laughter Yoga and Mindfulness-Based Stress Reduction (MBSR) Practices Applied to Women With Breast Cancer

The Effects of Laughter Yoga and Mindfulness-based Stress Reduction (MBSR) Practices Applied to Women With Breast Cancer Receiving Chemotherapy on Anxiety, Depression, Quality of Life and Spiritual Well-being Levels: A Randomized Controlled Study


Sponsor

Kafkas University

Enrollment

105 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Breast cancer is defined as the most common type of cancer that causes death among women (Siegel et al. 2019). It constitutes 24% of cancers and 15% of cancer-related deaths in women (T.R. Ministry of Health 2020). According to statistics made towards the end of 2020, there are 7.8 million women in the world who were diagnosed with breast cancer in the last 5 years and are alive. It is estimated that one in every 8 women will develop breast cancer in developed countries (WHO 2021). The Ministry of Health reported the frequency of breast cancer in our country as 45.6/100,000 in women in 2018. The incidence of breast cancer is reported to be higher, especially in the 45-54 age range (TC Ministry of Health 2020). Chemotherapy is one of the most frequently preferred treatment methods in the treatment of breast cancer and can cause serious side effects such as pain, nausea and vomiting, loss of appetite, shortness of breath, mouth sores, fatigue, insomnia, anxiety and depression, and may lead to a deterioration in the quality of life of patients (Waks and Winer 2019, Samami et al. 2021, Sajadian et al. 2017, McFarland et al. 2018, Hamer et al. 2017). In the international and national literature, no study has been found comparing the effects of laughter and mindfulness therapy on the anxiety, depression, quality of life and spiritual well-being experienced by breast cancer patients. In this study, it is planned to investigate the effects of laughter and mindfulness therapy applications on the anxiety, depression, quality of life and spiritual well-being levels of women with breast cancer receiving chemotherapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests two mind-body wellness practices — laughter yoga and mindfulness-based stress reduction (MBSR) — to see if they can reduce anxiety, depression, and fatigue in women with breast cancer who are currently receiving chemotherapy. **You may be eligible if:** - You are a woman 18 or older with stage 1 or stage 2 breast cancer - You are currently receiving chemotherapy at least once a month - You are within your first year of chemotherapy treatment - You scored 8 or higher on the Hospital Anxiety and Depression Scale - You have a smartphone and reliable internet access for online group sessions - You have at least a primary school education **You may NOT be eligible if:** - You do not have a smartphone or internet access - You are not currently receiving chemotherapy - You are in a more advanced stage of breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERthe laughter yoga group

They will gather in five-person chemotherapy rooms, and laughter therapy will be applied to the women in the application group while they are receiving chemotherapy. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week. The 9th and 16th sessions will be held face to face and the scales will be filled in face to face meetings in these weeks (at the end of the 4th week and the 8th week). Since patients receive chemotherapy treatment once a month, face-to-face sessions are planned to be administered while the patient is receiving treatment. (Those whose treatment timing frequency is not appropriate will be excluded). * Other sessions will be held online via smartphone applications. Online sessions will be determined according to the mutual decision of the participants, at a time convenient for the participants. * In the 12th week, all groups will have the scales filled in again.

OTHERthe mindfulness based stress reduction group

Mindfulnes therapy will be applied to the women in the application group while they are receiving chemotherapy, in five-person chemotherapy rooms. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week. The 9th and 16th sessions will be held face to face and the scales will be filled in face to face meetings in these weeks (at the end of the 4th week and the 8th week). Since patients receive chemotherapy treatment once a month, face-to-face sessions are planned to be administered while the patient is receiving treatment. (Those whose treatment timing frequency is not appropriate will be excluded). * Other sessions will be held online via smartphone applications. Online sessions will be determined according to the mutual decision of the participants, at a time convenient for the participants. * In the 12th week, all groups will have the scales filled in again.


Locations(1)

Hatay Iskenderun State Hospital

İskenderun, Hatay, Turkey (Türkiye)

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NCT06116812


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