Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
ID06116812

The Effects of Laughter Yoga and Mindfulness-Based Stress Reduction on Anxiety, Depression, Quality of Life, and Spiritual Well-being in Women With Breast Cancer Receiving Chemotherapy

Led by Kafkas University · Updated on 2024-08-14

105

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Breast cancer is one of the most common and deadly cancers among women worldwide, with a high frequency especially in women aged 45 to 54. Chemotherapy, a common treatment for breast cancer, can cause significant side effects such as pain, nausea, fatigue, anxiety, and depression, which may reduce patients' quality of life. This research aims to compare the effects of laughter yoga and mindfulness-based stress reduction (MBSR) on anxiety, depression, quality of life, and spiritual well-being in women receiving chemotherapy for breast cancer. Women participating in this study will be randomly assigned to one of three groups: a laughter yoga group, a mindfulness therapy group, or a control group receiving standard hospital care. Both the laughter yoga and mindfulness therapy groups will attend sessions twice a week for 8 weeks, each lasting 40 to 60 minutes. The 9th and 16th sessions will be held face to face during chemotherapy treatment, while other sessions will be conducted online by smartphone at mutually convenient times. After 12 weeks, all groups will complete follow-up assessments. Participants will undergo evaluations using the Hospital Anxiety and Depression Scale to measure anxiety and depression symptoms, the European Organization for Research and Treatment of Cancer Quality of Life Scale to assess quality of life, and a Spiritual Well-being Scale to evaluate spiritual health. Assessments will be completed at the 4th and 8th weeks during face-to-face meetings and again at 12 weeks. The study includes monitoring adherence and excludes participants who cannot attend at least 80% of sessions. The total study duration for participants is approximately 12 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 60 years
  • Diagnosed with stage 1 or stage 2 breast cancer
  • Receiving chemotherapy at least once a month and will continue during the study
  • Able to communicate and use a smartphone with internet access for group sessions
  • Within the first year of chemotherapy treatment (number of cycles)
  • Hospital Anxiety and Depression Scale score of 8 or higher
Not Eligible

You will not qualify if you...

  • Women who do not meet inclusion criteria or refuse to participate
  • Participation in less than 80% of study sessions
  • Current use of mindfulness therapy, laughter therapy, or complementary medicine outside the study
  • Diagnosed psychological disorders
  • Metastasis or recurrence of cancer
  • Chemotherapy terminated before study completion
  • Stage 3 or stage 4 breast cancer
  • Receiving chemotherapy for more than one year
  • Hospital Anxiety and Depression Scale score of 8 or below

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive either laughter yoga or mindfulness-based stress reduction therapy twice a week for 8 weeks during their chemotherapy sessions. Some sessions are held face to face during chemotherapy treatments, while others are conducted online at a time convenient for participants.

Twice-weekly sessions with 2 face-to-face visits during chemotherapy

Follow-up

Duration - 4 weeks

Participants complete additional assessments 4 weeks after the treatment ends to evaluate anxiety, depression, quality of life, and spiritual well-being.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Hatay Iskenderun State Hospital

İskenderun, Hatay, Turkey (Türkiye)

Actively Recruiting

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Research Team

Z

Zehra Coktay, phd stu

R

Rukiye Turk Delibalta, assoc prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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