Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654869
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Laughter Yoga Effect on Cancer Patients Physiopsychological Symptoms
Sponsor:
None
Organization:
None
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:
No
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 GPower-317 program the sample size was calculated with a test power of 080 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 α005 level and 80 power The patients to be included in the study will be randomized and assigned to the intervention n30 and control n30 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 GPower-317 program the sample size was calculated with a test power of 080 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 α005 level and 80 power The patients to be included in the study will be randomized and assigned to the intervention n30 and control n30 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None