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

Kafkas University

Status: Enrolling

Conditions: Breast Cancer; Life Quality; Mindfulness Therapy; Laughter Therapy; Anxiety and Depression; Spiritual Well-being

Treatments: Other: the mindfulness based stress reduction group; Other: the laughter yoga group

Study type: Interventional

Funder types: Other

Identifiers

NCT06116812

04578878

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who are 18 years of age or older, do not have communication problems, have and can use a smartphone, do not have internet problems to participate in group sessions, volunteer to participate in the study, receive chemotherapy at least once a month and will continue to receive chemotherapy during the study. Women with stage 1 and stage 2 breast cancer, women with primary and secondary education, women within the first year of treatment in terms of the number of cycles, women with a score of 8 or more on the Hospital anxiety and depression scale (0-7 points are normal, 8- A score of 10 is borderline, 11 and above indicates abnormality).

Exclusion criteria

• Women who did not meet the inclusion criteria, refused to participate in the study, and participated in less than 80% of the research practices (It is recommended to participate in at least 6 out of 8 sessions in the literature (Liu et al. 2022).),
• Women who use mindfulness therapy, laughter therapy or any complementary or integrative medicine in their daily lives outside the research, women who have a diagnosed psychological disease, metastasis or recurrence, and whose chemotherapy treatment was terminated before the study was completed,
• Women with stage 3 and stage 4 breast cancer, women who have been receiving chemotherapy for more than 1 year, women whose scores are 8 or below on the Hospital anxiety and depression scale (0-7 points indicate normal, 8-10 points indicate borderline, 11 and above indicate abnormality ).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

the laughter yoga group

Experimental group

Description:

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive laughter therapy twice a week for an average of 40-60 minutes for 8 weeks.

Treatment:

Other: the laughter yoga group

the mindfulness based stress reduction group

Experimental group

Description:

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive an average of 40-60 minutes of mindfulnes therapy twice a week for 8 weeks.

Treatment:

Other: the mindfulness based stress reduction group

the control group

No Intervention group

Description:

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive standard hospital care only.