Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532201
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Effects of Su Jok Therapy on Pain Fatigue Nausea-Vomiting and Spiritual Well-Being
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Su Jok Therapy on Pain Fatigue Nausea-Vomiting and Spiritual Well-Being Levels in Patients Receiving Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This study aims to examine the effects of sujok therapy on pain fatigue nausea-vomiting and spiritual well-being levels in patients receiving chemotherapy The following questions are being answered
Does sujok therapy affect pain levels in cancer patients
Does sujok therapy affect fatigue levels in cancer patients
Does sujok therapy affect nausea-vomiting levels in cancer patients
Does sujok therapy affect spiritual well-being levels in cancer patients
Does sujok therapy affect pain levels in cancer patients
Does sujok therapy affect fatigue levels in cancer patients
Does sujok therapy affect nausea-vomiting levels in cancer patients
Does sujok therapy affect spiritual well-being levels in cancer patients
Detailed Description:
Location of the study
Research data will be collected in the oncology unit of Muş State Hospital
Research universe sample research group
The research universe will consist of patients who apply to the oncology service in the hospital where the study is conducted and receive treatment It was determined that the required sample size for the study to exceed 80 with a 95 confidence interval 005 significance level and medium effect size was 68 people with 34 people in each group
Data collection tools
Descriptive Characteristics Form and Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale will be used as data collection tools
Descriptive Characteristics Form This form includes questions such as patients age gender socioeconomic level and educational status
Visual Analog Scale-VAS The severity of the symptom experienced by the patient is measured by marking a numbered point on this line VAS markings are repeated before and during the procedure regardless of the previous marking location In this study a 0-10 point scale will be used to evaluate the pain levels of individuals with VAS
Cancer Fatigue Scale KPSS Its validity and reliability in Turkey was conducted by Şahin et al in 2018 The scale consisting of a total of 15 items and three sub-dimensions has a 5-point Likert structure The highest score that can be obtained from the scale is 60 points It is stated that the higher the score the higher the fatigue level The internal consistency coefficient of the scale is 074
Rhodes nausea-vomiting and retching index NBSI Its validity and reliability in Turkish was conducted by Tan and Genç The scale which has a five-point Likert structure 0 least distress level 4 most distress has eight items that measure the number and severity of nausea-vomiting-retching in the last 24 hours The highest score that can be obtained from the scale is 32 and it is stated that the distress level increases as the score increases The internal consistency coefficient of the scale is 095 Spiritual Well-Being Scale Its Turkish adaptation was made by Aktürk et al 2017 The scale was created to determine the spiritual well-being of cancer patients or individuals with other chronic diseases The scale is a five-point Likert type and consists of 12 items The items of the scale have a numbering system between 0 and 4 0-Not at all 4-A lot The total score of the scale is 0-48 points A higher scale score indicates better spiritual well-being The total Cronbach alpha value of the scale is 087
RANDOMIZATION Patients who apply to the oncology unit for chemotherapy will be numbered according to the order of application Patients will be divided into experimental and control groups using the RANDOMIZER program
Control group No intervention will be made to this group When participating in the study participants will be asked to fill out the Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale after one and two months
Experimental group Su jok therapy will be applied to this group using black pepper seeds A total of 8 sessions twice a week for 4 weeks of therapy will be applied Black pepper seeds will be placed on a certain point of the patients hand and taped After two hours they will be asked to remove and throw away When participating in the study after one and two months participants will be asked to fill out the Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale
In the last stage the data obtained will be compared within and between groups
Research data will be collected in the oncology unit of Muş State Hospital
Research universe sample research group
The research universe will consist of patients who apply to the oncology service in the hospital where the study is conducted and receive treatment It was determined that the required sample size for the study to exceed 80 with a 95 confidence interval 005 significance level and medium effect size was 68 people with 34 people in each group
Data collection tools
Descriptive Characteristics Form and Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale will be used as data collection tools
Descriptive Characteristics Form This form includes questions such as patients age gender socioeconomic level and educational status
Visual Analog Scale-VAS The severity of the symptom experienced by the patient is measured by marking a numbered point on this line VAS markings are repeated before and during the procedure regardless of the previous marking location In this study a 0-10 point scale will be used to evaluate the pain levels of individuals with VAS
Cancer Fatigue Scale KPSS Its validity and reliability in Turkey was conducted by Şahin et al in 2018 The scale consisting of a total of 15 items and three sub-dimensions has a 5-point Likert structure The highest score that can be obtained from the scale is 60 points It is stated that the higher the score the higher the fatigue level The internal consistency coefficient of the scale is 074
Rhodes nausea-vomiting and retching index NBSI Its validity and reliability in Turkish was conducted by Tan and Genç The scale which has a five-point Likert structure 0 least distress level 4 most distress has eight items that measure the number and severity of nausea-vomiting-retching in the last 24 hours The highest score that can be obtained from the scale is 32 and it is stated that the distress level increases as the score increases The internal consistency coefficient of the scale is 095 Spiritual Well-Being Scale Its Turkish adaptation was made by Aktürk et al 2017 The scale was created to determine the spiritual well-being of cancer patients or individuals with other chronic diseases The scale is a five-point Likert type and consists of 12 items The items of the scale have a numbering system between 0 and 4 0-Not at all 4-A lot The total score of the scale is 0-48 points A higher scale score indicates better spiritual well-being The total Cronbach alpha value of the scale is 087
RANDOMIZATION Patients who apply to the oncology unit for chemotherapy will be numbered according to the order of application Patients will be divided into experimental and control groups using the RANDOMIZER program
Control group No intervention will be made to this group When participating in the study participants will be asked to fill out the Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale after one and two months
Experimental group Su jok therapy will be applied to this group using black pepper seeds A total of 8 sessions twice a week for 4 weeks of therapy will be applied Black pepper seeds will be placed on a certain point of the patients hand and taped After two hours they will be asked to remove and throw away When participating in the study after one and two months participants will be asked to fill out the Visual Analog Scale-VAS Cancer Fatigue Scale Rhodes Nausea-Vomiting and Retching Index and Spiritual Well-Being Scale
In the last stage the data obtained will be compared within and between groups
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