Breast CancerNCT06116812
The Effects of Laughter Yoga and Mindfulness-Based Stress Reduction (MBSR) Practices Applied to Women With Breast Cancer
A study testing the laughter yoga group and the mindfulness based stress reduction group in people with Breast Cancer and Laughter Therapy, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Laughter Therapy, Mindfulness Therapy
- What is being tested?
- the laughter yoga group and the mindfulness based stress reduction group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Iskenderun State Hospital
İskenderun, Hatay
zehra coktay, phd stu, +90 543 203 52 43, zehracoktay1@gmail.com
About this study
Official title: 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
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).
Read more
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
- Being tested
- the laughter yoga group, the mindfulness based stress reduction group
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the laughter yoga groupOther
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 mindfulness based stress reduction groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Higher scores on the functional scale indicate higher/healthier functions, and higher scores on the general health status/quality of life indicate higher quality of life. However, high scores on the symptom scale indicate a high rate of symptomatology/problems (Fayers et al. 2001).
Measured: 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
Meaning sub-dimension (Items 2,3,5,8) has a total score of 0-16 points, Peace sub-dimension (Items 1,4,6,7) has a total score of 0-16 points, Belief sub-dimension (Items 9,10,11) ,12) total score ranges from 0-16 points, and the total score of the scale is 0-48 points. A higher scale score indicates better spiritual well-being.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Coktay, Kafkas University
- Investigators
- zehra Coktay, phd stu, Principal investigator, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116812
- Sponsor's protocol ID
- 04578878
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06116812
- Acronym / sponsor ID
- 04578878
- Conditions
- Breast Cancer, Laughter Therapy, Mindfulness Therapy, Life Quality, Anxiety and Depression, Spiritual Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the laughter yoga group | Experimental | Other: the laughter yoga groupWomen 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. |
| the mindfulness based stress reduction group | Experimental | Other: the mindfulness based stress reduction groupWomen 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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 ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the laughter yoga groupThey 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. | Other | the laughter yoga group |
| the mindfulness based stress reduction groupMindfulnes 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. | Other | the mindfulness based stress reduction group |
Primary outcome
Hospital anxiety and depression scale outcomes
Time frame: 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.
According to the scoring, 0-7 is considered as not sick, 8-10 is borderline sick, and 11 and above is considered seriously ill.
2 secondary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-30) outcomes
Time frame: 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
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zehra Coktay, phd stu principal investigator
Kafkas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the laughter yoga group and the mindfulness based stress reduction group in people with Breast Cancer and Laughter Therapy, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zehra Coktay, phd stu (+90 5432035243, zehracoktay1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital anxiety and depression scale outcomes (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.