Clinical trial NCT06654869: Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms
Official title: Laugh Against Cancer - Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Nurse's Role
Quality of Life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The universe of this study will consist of cancer patients and their relatives who are hospitalized in the medical oncology clinic of Atatürk University Research and Practice Hospital between Oct 2024 and Feb 2024. The researcher will stratify the patients in the control and intervention groups according to age and the type of treatment they receive in order to ensure homogeneity. Accordingly, the patient in each stratum will be selected from one of the labels prepared in a bag with the words "experimental" and "control" written on it and the patient will be included in the group written on the label. The patients in the control and intervention groups will not know which group they are in, but only the researcher will know who is in which group. In this way, blinding will be ensured and the study will be completed as single-blind.

Detailed description: Sample Size Calculation:

The minimum number of people to be included in the sample was calculated by performing a power analysis. Using the "G.Power-3.1.7" program, the sample size was calculated with a test power of 0.80. As a result of the power analysis, it was determined that a total of 60 patients should be included in the control and intervention groups at α=0.05 level and 80% power. The patients to be included in the study will be randomized and assigned to the intervention (n=30) and control (n=30) groups. Volunteer acceptance for the study will begin after the acceptance of the study within the created work packages.

Data collection tools:

The data of the study will be collected in the experimental and control groups using the "Personal Information Form", "Edmonton Symptom Assesment Scale", "Herth Hope Scale" and "Life Engagement Scale".

Criteria for volunteers to be included in the study:

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Eligibility criteria: Inclusion Criteria:

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Exclusion Criteria:

1. Being under 18 years of age
2. Not having information about the disease
3. Having a physical illness or cognitive disability that prevents understanding the scales used for data collection and the education given, and being diagnosed with a psychiatric disease
4. Being illiterate
5. Not being open to communication and cooperation

Primary outcomes:
measure: Edmonton Symptom Assesment Scale (ESAS)
timeFrame: 6 weeks
measure: Life Engagement Scale
timeFrame: 6 weeks
measure: Herth Hope Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: