Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Effects of Su Jok Seed Therapy Application on Pain Anxiety and Psychological Resilience in Patients Hospitalized in the Oncology Ward
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Su Jok Seed Therapy Application on Pain Anxiety and Psychological Resilience in Patients Hospitalized in the Oncology Ward
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:
The aim of this clinical trial is to determine the effects of su jok seed therapy on pain anxiety and psychological resilience in patients hospitalized in the oncology ward This study seeks answers to the following questions Does su jok seed therapy affect the pain levels of cancer patients Does su jok seed therapy affect the anxiety levels of cancer patients Does su jok seed therapy affect the Psychological resilience levels of cancer patients There will be an experimental and control group in the study and the effectiveness of sujok application will be examined
A total of 8 sessions of su jok seed therapy will be applied to the experimental group twice a week for a month No intervention will be made to the control group
Individuals over 18 years old without communication problems and diagnosed with cancer will be included in the sample
A total of 8 sessions of su jok seed therapy will be applied to the experimental group twice a week for a month No intervention will be made to the control group
Individuals over 18 years old without communication problems and diagnosed with cancer will be included in the sample
Detailed Description:
Location of the study
Research data will be collected in the oncology unit of Muş State Hospital
Time of the study
Research data will be collected between June 15 and December 31 2024
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 Before determining the sample of the study a priori power analysis was performed in the GPOWER 3197 Package Program based on the Dependent Groups t Test It was determined that the number of samples required for the study to exceed 80 with a 95 confidence interval a significance level of 005 and a medium effect size was 68 people with 34 people in each group In order for the study to exceed 80 power and considering possible data losses the total sample number was determined as N 80 with 40 in the intervention group and 40 in the control group
Required manpower for the research
Güzel Nur Yıldız Analysis findings and writing the method Arzu KARAKAYA Data collection she received the Su Jok certificate by attending the Su Jok certification training given by the International Su Jok Association discussion writing introduction writing and general organization
Research method and data collection tools
Descriptive Characteristics Form and State Anxiety Scale Brief Psychological Resilience Scale and Visual Comparison Scale will be used as data collection tools
Descriptive Characteristics Form This form prepared by the researcher based on literature includes questions such as the age gender socioeconomic level and educational status of the patients
State Anxiety Scale The State Anxiety Inventory expresses how the participant feels at a certain moment and period According to the severity of the emotions and behaviors expressed in the items of the scale one of the options 1 None 2 A Little 3 A Lot 4 Completely is selected Karadağ Uğur 2021
Brief Psychological Resilience Scale BRS The Brief Psychological Resilience Scale BRS is a 5-point Likert-type measurement tool consisting of six items developed to measure the psychological resilience of individuals The scale was adapted to Turkish by Doğan in 2015 When the scale is graded items 2 4 and 6 are scored reversely A high score from the scale indicates a high level of psychological resilience while a low score indicates a low level of psychological resilience Doğan 2015 A score between 6-11 indicates a low level 12-22 indicates a medium level and 23-30 indicates a high level The Cronbach Alpha coefficient calculated in the validity and reliability study of the scale is 079 Doğan 2015 Visual Analog Scale VAS Developed by Freyd in 1983 the scale is a reliable measurement tool developed to measure the pain levels of individuals The scale is simple attractive can be filled out quickly and can be scored easily Freyd 1923 There are subjective descriptive statements at both ends of a 10-cm ruler
RANDOMIZATION Patients applying to the oncology unit will be separated into single and double according to the order of application Single patients will form the experimental group and double patients will form the control group An application for a Clinical Trials ID number will be made after the ethics committee is received
Control group No intervention will be made to this group When the participants participate in the study after one and two months they will be asked to fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale
Experimental group This group will be given su jok therapy using green mung bean seeds A total of 8 sessions twice a week for 4 weeks of therapy will be applied Green mung bean 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 it away When the participants participate in the study after one and two months they will be asked to fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale
In the last stage the data obtained will be compared within and between groups
Su Jok Application Process Steps The researcher received the Su Jok certificate by attending the Su Jok certification training given by the International Su Jok Association Green mung bean seeds were used in the research The seed will be purchased from an institution that is certified as organic and has an entrepreneurial certificate Su Jok will be applied to the reflection points on the hand based on the painful area of the individual The painful areas will be determined with the applicator and green mung bean will be placed in these areas It is planned to apply a circular massage to the areas where the seeds are located for 30 minutes and to carry out all the steps as follows
Before the Procedure Informing the individual about the procedure
Providing hand hygiene
A comfortable position will be provided considering the individuals limitations
In order for the hands not to be cold the researcher will warm them by rubbing them together and the patients hand will be grasped
Su Jok applicator has been taken Procedure Order Individuals pain areas will be determined and reflection points corresponding to these areas on the yin and yang sides will be determined
The individual will be asked to state when they experience pain and pulling sensations at the points touched by the applicator
Determining painful reflection points on the back of the individuals hand
When each reflection point is determined green mung bean will be placed on the relevant point and fixed with a plaster band The same procedure will be applied to all painful points until the individual states that there are no more painful points
Massage will be applied to the point where the seed is fixed for 30 minutes After the Procedure The individual will be helped to take a comfortable position
Hands will be washed
Data Collection
Research data will be collected by the researcher using the face-to-face interview method First individuals who will participate in the study will be determined and individuals will be randomly divided into experimental and control groups Participants in the experimental and control groups will first fill out the Voluntary Consent Form State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale The experimental group will receive su jok therapy with green mung bean twice a week for a total of 4 weeks 8 sessions in total The control group will not receive any intervention Participants will fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale again after one month and two months The researchers will not perform any invasive procedures Su jok therapy with fresh yeast seed is performed by placing seeds on certain points on the hands of individuals Individuals will not swallow this seed they will just put it in a certain place on their hand tape it and wait for two hours then take it out and throw it away Therefore no invasive procedure will be performed on individuals in this therapy In order to collect the data written permission will first be obtained from the institutions where the research is conducted Before the interview with the individuals explanations will be made about the purpose and objectives of the research the benefits to be obtained from the research and the time they will spend for the interview and their verbal consent will be obtained In the Google Forms method an explanation will be made on the first page of the form and consent will be obtained The data will be collected in an average of 15-30 minutes
Data analysis
The data will be evaluated in the SPSS Statistical Package for Social Sciences for Windows Version 220 package program In the evaluation of the data the statistical significance value will be accepted as 005 the Type 1 error will be kept as 5 and the evaluation will be made with a 95 confidence interval Skewness and Kurtosis values will be examined in order to determine whether the measurements show a normal distribution According to Skewness the range of 1 -1 is normal and the range of 2 -1 is normal for Kurtosis Data will be analyzed in light of this information In intergroup comparisons the t-test will be used for independent groups in measurements showing normal distribution and the Mann Whitney U test will be used for measurements not showing normal distribution In intragroup pretest posttest score comparisons the t-test will be used for dependent samples in measurements showing normal distribution and the Wilcoxon test will be used for measurements not showing normal distribution In order to determine the difference in repeated measurements the single factor anova will be used for Renewed Measurements in measurements showing normal distribution and the Friedman test will be used for measurements not showing normal distribution In order to determine which groups the difference originates from the t-test will be used for dependent groups in measurements showing normal distribution and the Wilcoxon Sequential Signs test will be used for measurements not showing normal distribution
Research data will be collected in the oncology unit of Muş State Hospital
Time of the study
Research data will be collected between June 15 and December 31 2024
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 Before determining the sample of the study a priori power analysis was performed in the GPOWER 3197 Package Program based on the Dependent Groups t Test It was determined that the number of samples required for the study to exceed 80 with a 95 confidence interval a significance level of 005 and a medium effect size was 68 people with 34 people in each group In order for the study to exceed 80 power and considering possible data losses the total sample number was determined as N 80 with 40 in the intervention group and 40 in the control group
Required manpower for the research
Güzel Nur Yıldız Analysis findings and writing the method Arzu KARAKAYA Data collection she received the Su Jok certificate by attending the Su Jok certification training given by the International Su Jok Association discussion writing introduction writing and general organization
Research method and data collection tools
Descriptive Characteristics Form and State Anxiety Scale Brief Psychological Resilience Scale and Visual Comparison Scale will be used as data collection tools
Descriptive Characteristics Form This form prepared by the researcher based on literature includes questions such as the age gender socioeconomic level and educational status of the patients
State Anxiety Scale The State Anxiety Inventory expresses how the participant feels at a certain moment and period According to the severity of the emotions and behaviors expressed in the items of the scale one of the options 1 None 2 A Little 3 A Lot 4 Completely is selected Karadağ Uğur 2021
Brief Psychological Resilience Scale BRS The Brief Psychological Resilience Scale BRS is a 5-point Likert-type measurement tool consisting of six items developed to measure the psychological resilience of individuals The scale was adapted to Turkish by Doğan in 2015 When the scale is graded items 2 4 and 6 are scored reversely A high score from the scale indicates a high level of psychological resilience while a low score indicates a low level of psychological resilience Doğan 2015 A score between 6-11 indicates a low level 12-22 indicates a medium level and 23-30 indicates a high level The Cronbach Alpha coefficient calculated in the validity and reliability study of the scale is 079 Doğan 2015 Visual Analog Scale VAS Developed by Freyd in 1983 the scale is a reliable measurement tool developed to measure the pain levels of individuals The scale is simple attractive can be filled out quickly and can be scored easily Freyd 1923 There are subjective descriptive statements at both ends of a 10-cm ruler
RANDOMIZATION Patients applying to the oncology unit will be separated into single and double according to the order of application Single patients will form the experimental group and double patients will form the control group An application for a Clinical Trials ID number will be made after the ethics committee is received
Control group No intervention will be made to this group When the participants participate in the study after one and two months they will be asked to fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale
Experimental group This group will be given su jok therapy using green mung bean seeds A total of 8 sessions twice a week for 4 weeks of therapy will be applied Green mung bean 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 it away When the participants participate in the study after one and two months they will be asked to fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale
In the last stage the data obtained will be compared within and between groups
Su Jok Application Process Steps The researcher received the Su Jok certificate by attending the Su Jok certification training given by the International Su Jok Association Green mung bean seeds were used in the research The seed will be purchased from an institution that is certified as organic and has an entrepreneurial certificate Su Jok will be applied to the reflection points on the hand based on the painful area of the individual The painful areas will be determined with the applicator and green mung bean will be placed in these areas It is planned to apply a circular massage to the areas where the seeds are located for 30 minutes and to carry out all the steps as follows
Before the Procedure Informing the individual about the procedure
Providing hand hygiene
A comfortable position will be provided considering the individuals limitations
In order for the hands not to be cold the researcher will warm them by rubbing them together and the patients hand will be grasped
Su Jok applicator has been taken Procedure Order Individuals pain areas will be determined and reflection points corresponding to these areas on the yin and yang sides will be determined
The individual will be asked to state when they experience pain and pulling sensations at the points touched by the applicator
Determining painful reflection points on the back of the individuals hand
When each reflection point is determined green mung bean will be placed on the relevant point and fixed with a plaster band The same procedure will be applied to all painful points until the individual states that there are no more painful points
Massage will be applied to the point where the seed is fixed for 30 minutes After the Procedure The individual will be helped to take a comfortable position
Hands will be washed
Data Collection
Research data will be collected by the researcher using the face-to-face interview method First individuals who will participate in the study will be determined and individuals will be randomly divided into experimental and control groups Participants in the experimental and control groups will first fill out the Voluntary Consent Form State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale The experimental group will receive su jok therapy with green mung bean twice a week for a total of 4 weeks 8 sessions in total The control group will not receive any intervention Participants will fill out the State Anxiety Scale Brief Resilience Scale and Visual Comparison Scale again after one month and two months The researchers will not perform any invasive procedures Su jok therapy with fresh yeast seed is performed by placing seeds on certain points on the hands of individuals Individuals will not swallow this seed they will just put it in a certain place on their hand tape it and wait for two hours then take it out and throw it away Therefore no invasive procedure will be performed on individuals in this therapy In order to collect the data written permission will first be obtained from the institutions where the research is conducted Before the interview with the individuals explanations will be made about the purpose and objectives of the research the benefits to be obtained from the research and the time they will spend for the interview and their verbal consent will be obtained In the Google Forms method an explanation will be made on the first page of the form and consent will be obtained The data will be collected in an average of 15-30 minutes
Data analysis
The data will be evaluated in the SPSS Statistical Package for Social Sciences for Windows Version 220 package program In the evaluation of the data the statistical significance value will be accepted as 005 the Type 1 error will be kept as 5 and the evaluation will be made with a 95 confidence interval Skewness and Kurtosis values will be examined in order to determine whether the measurements show a normal distribution According to Skewness the range of 1 -1 is normal and the range of 2 -1 is normal for Kurtosis Data will be analyzed in light of this information In intergroup comparisons the t-test will be used for independent groups in measurements showing normal distribution and the Mann Whitney U test will be used for measurements not showing normal distribution In intragroup pretest posttest score comparisons the t-test will be used for dependent samples in measurements showing normal distribution and the Wilcoxon test will be used for measurements not showing normal distribution In order to determine the difference in repeated measurements the single factor anova will be used for Renewed Measurements in measurements showing normal distribution and the Friedman test will be used for measurements not showing normal distribution In order to determine which groups the difference originates from the t-test will be used for dependent groups in measurements showing normal distribution and the Wilcoxon Sequential Signs test will be used for measurements not showing normal distribution
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