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Trial Title:
Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms
NCT ID:
NCT06654869
Condition:
Cancer
Nurse's Role
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
lauhgter yoga
Description:
include laughter yoga effects on cancer patients' symptom management
Arm group label:
Arm 1
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Ataturk University
Agency class:
Other
Source:
Ataturk University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654869