Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-04-02 @ 5:01 PM
Study NCT ID:
NCT06654869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
Laugh Against Cancer - Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms; a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: