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

NCT06116812 | Recruiting DMC

• 1 other identifier: 04578878
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital anxiety and depression scale outcomes

  According to the scoring, 0-7 is considered as not sick, 8-10 is borderline sick, and 11 and above is considered seriously ill.

  The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith (1983). In the scale consisting of 14 items, 7 of the items measure anxiety symptoms and the other 7 measure depression symptoms.

Secondary Outcomes (2)

• European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-30) outcomes

  It is an assessment tool used in cancer patients and whose reliability, applicability and validity have been tested in large patient populations in 12 different countries (Björdal et al. 1999).

• Spiritual well-being scale (Facıt-Sp-12) outcomes

  The scale was developed by Peterman and his colleagues to determine the spiritual well-being of individuals with cancer and other chronic diseases (Peterman et al. 2002).

Study Arms (3)

the laughter yoga group

EXPERIMENTAL

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.

Other: the laughter yoga group

the mindfulness based stress reduction group

EXPERIMENTAL

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.

Other: the mindfulness based stress reduction group

the control group

NO INTERVENTION

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

Interventions

the laughter yoga group OTHER

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.

the laughter yoga group

the mindfulness based stress reduction group OTHER

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.

the mindfulness based stress reduction group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Since breast cancer is a type of cancer more common in women, only patients diagnosed with female breast cancer were included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Hatay Iskenderun State Hospital

İskenderun, Hatay, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• zehra Coktay, phd stu

  Kafkas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zehra Coktay, phd stu

CONTACT

+90 5432035243; zehracoktay1@gmail.com

Rukiye Turk Delibalta, assoc prof

CONTACT

+90 5313740528; rahsantur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)