Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263257
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-01-18
Brief Title:
The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients
Sponsor:
Busra Nur Temur
Organization:
Akdeniz University
Study Overview
Official Title:
The Effect of Mandala Art Therapy on Anxiety and Comfort Levels in Living Kidney Transplant Recipients A Mixed-Methods Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients While kidney transplantation improves the recipients quality of life it may also expose them to psychological physical and social challenges post-transplant This situation can increase recipients levels of anxiety making them cope with psychiatric issues and affecting their comfort levels Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients
Mandala art therapy is known as an effective method that supports the mental health physical functioning and social and emotional well-being of individuals with health issues Mandalas can contribute to comfort by promoting inner peace focusing attention and encouraging creative expression This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients To achieve this goal a mixed-methods study using a randomized controlled and nested experimental design is planned
The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients This information may guide healthcare professionals in enhancing kidney transplant recipients psychological and emotional well-being reducing stress and promoting higher levels of comfort through mandala art therapy
H0a There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients
H0b There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients
Mandala art therapy is known as an effective method that supports the mental health physical functioning and social and emotional well-being of individuals with health issues Mandalas can contribute to comfort by promoting inner peace focusing attention and encouraging creative expression This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients To achieve this goal a mixed-methods study using a randomized controlled and nested experimental design is planned
The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients This information may guide healthcare professionals in enhancing kidney transplant recipients psychological and emotional well-being reducing stress and promoting higher levels of comfort through mandala art therapy
H0a There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients
H0b There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients
Detailed Description:
This study is planned in three stages
In the first stage the preparation and pre-application of the Mandala Art Therapy training program for kidney transplant recipients in the intervention group will take place
In the second stage for the intervention group the first measurement afternoon of the day before surgery will include State-Trait Anxiety Inventory STAI and General Comfort Questionaire GCQ the second measurement Postoperative Day 5 - discharge day will include State Anxiety Inventory and General Comfort Questionaire The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows Session 1 on Postoperative Day 5 - discharge day after the scales Session 2 on 1st Control 1 week after surgery Session 3 on 2nd Control 2 weeks after surgery and the third measurement at 3rd Control 1 month after surgery For the Control Group the third measurement 1 month after surgery will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire This stage aims to conduct a randomized controlled study
In the third stage semi-structured interviews will be conducted with the intervention group where the Mandala Art Therapy training program is implemented for kidney transplant recipients Qualitative research methods will be employed in this stage
The study population will consist of kidney transplant recipients admitted to the Organ Transplantation Clinic of Akdeniz University Hospital in Antalya and those who apply to the Polyclinic of Prof Dr Tuncer Karpuzoğlu Organ Transplant Institute In this center 196 living donor kidney transplants were performed in 2021 191 in 2022 and until June 19 2023 99 living donor kidney transplant surgeries have been carried out
First Measurement State-Trait Anxiety Inventory and General Comfort Questionaire will be collected from elective living donor kidney transplant recipients in their hospital rooms on the afternoon of the day before surgery
Second Measurement State Anxiety Inventory and General Comfort Questionaire will be collected from kidney transplant recipients on Postoperative Day 5 - discharge day before the intervention After data collection for the Intervention Group
Session 1 of the Mandala Art Therapy training program on Postoperative Day 5 - discharge day after the scales Session 2 on 1st Control 1 week after surgery Session 3 on 2nd Control 2 weeks after surgery Third measurement at 3rd Control 1 month after surgery includes State-Trait Anxiety Inventory and General Comfort Questionaire
For the Control Group a free-drawing activity will be conducted on Postoperative Day 5 - discharge day and the third measurement 1 month after surgery will be collected through self-reporting for State-Trait Anxiety Inventory and General Comfort Questionaire
To enhance the robustness of the research findings and increase reliability the study is planned to be conducted with a total of 72 participants comprising 36 in the experimental group and 36 in the control group representing a 40 increase during the course of the study
Variables
Independent Variable
Mandala Art Therapy Training
Dependent Variables
State Anxiety Trait Anxiety Comfort Level
Randomization
In this study random assignment and concealment of randomization are planned to control selection bias Block randomization will be employed as the randomization method to ensure balance between the intervention and control groups The block size will be determined during the implementation of block randomization Numbers will be generated using the website wwwrandomizerorg and the generated numbers will be placed in opaque sealed envelopes The randomization process will be conducted by a person not involved in the research team After the researcher determines that the participant meets the inclusion criteria does not have exclusion criteria and obtains their consent scales pre-test will be administered Subsequently a team member will open the envelope provided by an external source to determine the group allocation of the participant
Blinding
In this study blinding of participants and the statistician is planned Blinding of the researcher implementing the intervention will not be possible Since participants will not know to which group they are assigned participant blinding is considered feasible Data related to the scales post-test will be coded as A and B without indicating whether they belong to the intervention or control group The coded data will be analyzed by a statistician without knowledge of group allocation After the statistical analyses are completed the coding for the intervention and control groups will be revealed This blinding technique is intended to minimize statistical bias
State-Trait Anxiety Inventory STAI
The State-Trait Anxiety Inventory STAI was developed to assess state and trait anxiety in research and clinical applications This scale consists of two subscales State Anxiety and Trait Anxiety each comprising 20 questions Reliability and validity information for the STAI was reported in the psychometric information handbook by Spielberger According to this report Cronbachs Alpha Internal Consistency coefficient for the State Anxiety Scale is indicated as 073-086 and for the Trait Anxiety Scale it is 086-093 The scale was adapted to Turkish and validated by Öner and Le Compte The reliability of the scale was reported as Cronbachs Alpha coefficient of 083-092 for the State Anxiety Scale and 086-092 for the Trait Anxiety Scale
The State Anxiety Scale describes how the individual feels in specific environmental conditions during a specific time interval when the test is administered It is a Likert-type scale where a score between 1-4 can be given for each question Participants are expected to mark only one of the options 1 Not at all 2 Somewhat 3 Very much 4 Completely based on the intensity of their current feelings The Trait Anxiety Scale requires participants to indicate how they mostly feel marking one of the options 1 Almost never 2 Sometimes 3 Often 4 Almost always based on the intensity of their feelings
There are two types of expressions in the scales direct expressions representing positive emotions and reversed expressions representing negative emotions In the State Anxiety Scale 10 items are reversed and in the Trait Anxiety Scale 7 items are reversed When scoring reversed expressions statements with a value of 1 are converted to 4 and those with a value of 4 are converted to 1 Scores obtained from both scales range between a minimum of 20 and a maximum of 80 A high score indicates a high level of anxiety while a low score indicates a low level of anxiety To calculate the State Anxiety and Trait Anxiety scores the total score obtained for direct expressions is subtracted from the total score obtained for reversed expressions and predetermined constant values are added This value is 50 for the State Anxiety variable and 35 for the Trait Anxiety variable The final value obtained represents the participants anxiety score A score of 0-19 indicates no anxiety 20-39 indicates mild anxiety 40-59 indicates moderate anxiety and 60-79 indicates severe anxiety An average anxiety score of 60 and above suggests that individuals need professional help The Cronbachs alpha reliability coefficient will be calculated for the sample in this research The permission letter for the State-Trait Anxiety Inventory was obtained on June 19 2023 with the signature of Sibel Erenel President of YÖRET Foundation on behalf of Prof Dr Necla Öner
General Comfort Questionnaire GCQ
The General Comfort Questionnaire developed by Katharina Kolcaba underwent a Turkish validation and reliability study conducted by Kuğuoğlu and Karabacak Cronbachs Alpha 85 55-85 for subscales When testing the construct validity of the General Comfort Questionnaire and its sub-dimensions using the Satisfaction scale and its sub-dimensions a significant positive relationship was found between the level of comfort and satisfaction with relaxation procedures r225 p005 satisfaction with nurses r279 p001 satisfaction with physicians r199 p001 satisfaction with auxiliary personnel r198 p001 satisfaction with meals r206 p001 satisfaction with the room r214 p001 and overall satisfaction with the hospital r241 p001 The scale consists of a total of 48 items and is presented in a four-point Likert type The comfort levels of the scale are relief 16 items relaxation 17 items and overcoming problems 15 items The response orders of the scale composed of positive and negative items are given in a mixed manner Accordingly high scores 4 in positive items indicate high comfort and low scores indicate low comfort In the evaluation of the scale the obtained negative scores are reverse coded and summed with positive items The highest total score that can be obtained from the scale is 192 and the lowest total score is 48 A low comfort score is expressed with one point while a high comfort score is represented by four points In Kolcabas study she determined Cronbachs alpha value for internal consistency control as 88 overall and as 66 - 80 for sub-scales The Cronbach alpha reliability coefficient will be calculated for the sample of this study The permission letter for the General Comfort Questionnaire was obtained on June 19 2023 by Prof Dr Ükke Karabacak
Data Analysis For the evaluation of the data obtained in the study the IBM SPSS 230 software package will be utilized Descriptive statistics will be presented using frequencies n and meanstandard deviation Min-Max values Pearson chi-square test and Fishers Exact test will be employed for the analysis of relationships between categorical variables The Shapiro-Wilks test will be used for the analysis of the normality assumption
In cases where the assumption of the normal distribution is not met for the analysis of score differences between the two groups the Mann-Whitney U test will be used when non-parametric and the Students t-test will be applied when parametric For the non-parametric comparison of scores for three or more groups the Kruskal-Wallis test will be utilized and in cases where significance is found the Bonferroni-Dunn test will serve as a post-hoc test If the assumption of normal distribution is met the ANOVA test will be employed for the comparison of scores for three or more groups with the Tukey HSD test for pairwise comparisons
For the analysis of the relationship between the scores of state and trait anxiety subscales and other variables the Pearson correlation test will be conducted when the assumption of normal distribution is satisfied and the Spearman correlation test will be used when it is not met The Cronbachs alpha coefficient will be calculated for the reliability analysis of the scales
A significance level of p005 will be considered in the study
In the first stage the preparation and pre-application of the Mandala Art Therapy training program for kidney transplant recipients in the intervention group will take place
In the second stage for the intervention group the first measurement afternoon of the day before surgery will include State-Trait Anxiety Inventory STAI and General Comfort Questionaire GCQ the second measurement Postoperative Day 5 - discharge day will include State Anxiety Inventory and General Comfort Questionaire The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows Session 1 on Postoperative Day 5 - discharge day after the scales Session 2 on 1st Control 1 week after surgery Session 3 on 2nd Control 2 weeks after surgery and the third measurement at 3rd Control 1 month after surgery For the Control Group the third measurement 1 month after surgery will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire This stage aims to conduct a randomized controlled study
In the third stage semi-structured interviews will be conducted with the intervention group where the Mandala Art Therapy training program is implemented for kidney transplant recipients Qualitative research methods will be employed in this stage
The study population will consist of kidney transplant recipients admitted to the Organ Transplantation Clinic of Akdeniz University Hospital in Antalya and those who apply to the Polyclinic of Prof Dr Tuncer Karpuzoğlu Organ Transplant Institute In this center 196 living donor kidney transplants were performed in 2021 191 in 2022 and until June 19 2023 99 living donor kidney transplant surgeries have been carried out
First Measurement State-Trait Anxiety Inventory and General Comfort Questionaire will be collected from elective living donor kidney transplant recipients in their hospital rooms on the afternoon of the day before surgery
Second Measurement State Anxiety Inventory and General Comfort Questionaire will be collected from kidney transplant recipients on Postoperative Day 5 - discharge day before the intervention After data collection for the Intervention Group
Session 1 of the Mandala Art Therapy training program on Postoperative Day 5 - discharge day after the scales Session 2 on 1st Control 1 week after surgery Session 3 on 2nd Control 2 weeks after surgery Third measurement at 3rd Control 1 month after surgery includes State-Trait Anxiety Inventory and General Comfort Questionaire
For the Control Group a free-drawing activity will be conducted on Postoperative Day 5 - discharge day and the third measurement 1 month after surgery will be collected through self-reporting for State-Trait Anxiety Inventory and General Comfort Questionaire
To enhance the robustness of the research findings and increase reliability the study is planned to be conducted with a total of 72 participants comprising 36 in the experimental group and 36 in the control group representing a 40 increase during the course of the study
Variables
Independent Variable
Mandala Art Therapy Training
Dependent Variables
State Anxiety Trait Anxiety Comfort Level
Randomization
In this study random assignment and concealment of randomization are planned to control selection bias Block randomization will be employed as the randomization method to ensure balance between the intervention and control groups The block size will be determined during the implementation of block randomization Numbers will be generated using the website wwwrandomizerorg and the generated numbers will be placed in opaque sealed envelopes The randomization process will be conducted by a person not involved in the research team After the researcher determines that the participant meets the inclusion criteria does not have exclusion criteria and obtains their consent scales pre-test will be administered Subsequently a team member will open the envelope provided by an external source to determine the group allocation of the participant
Blinding
In this study blinding of participants and the statistician is planned Blinding of the researcher implementing the intervention will not be possible Since participants will not know to which group they are assigned participant blinding is considered feasible Data related to the scales post-test will be coded as A and B without indicating whether they belong to the intervention or control group The coded data will be analyzed by a statistician without knowledge of group allocation After the statistical analyses are completed the coding for the intervention and control groups will be revealed This blinding technique is intended to minimize statistical bias
State-Trait Anxiety Inventory STAI
The State-Trait Anxiety Inventory STAI was developed to assess state and trait anxiety in research and clinical applications This scale consists of two subscales State Anxiety and Trait Anxiety each comprising 20 questions Reliability and validity information for the STAI was reported in the psychometric information handbook by Spielberger According to this report Cronbachs Alpha Internal Consistency coefficient for the State Anxiety Scale is indicated as 073-086 and for the Trait Anxiety Scale it is 086-093 The scale was adapted to Turkish and validated by Öner and Le Compte The reliability of the scale was reported as Cronbachs Alpha coefficient of 083-092 for the State Anxiety Scale and 086-092 for the Trait Anxiety Scale
The State Anxiety Scale describes how the individual feels in specific environmental conditions during a specific time interval when the test is administered It is a Likert-type scale where a score between 1-4 can be given for each question Participants are expected to mark only one of the options 1 Not at all 2 Somewhat 3 Very much 4 Completely based on the intensity of their current feelings The Trait Anxiety Scale requires participants to indicate how they mostly feel marking one of the options 1 Almost never 2 Sometimes 3 Often 4 Almost always based on the intensity of their feelings
There are two types of expressions in the scales direct expressions representing positive emotions and reversed expressions representing negative emotions In the State Anxiety Scale 10 items are reversed and in the Trait Anxiety Scale 7 items are reversed When scoring reversed expressions statements with a value of 1 are converted to 4 and those with a value of 4 are converted to 1 Scores obtained from both scales range between a minimum of 20 and a maximum of 80 A high score indicates a high level of anxiety while a low score indicates a low level of anxiety To calculate the State Anxiety and Trait Anxiety scores the total score obtained for direct expressions is subtracted from the total score obtained for reversed expressions and predetermined constant values are added This value is 50 for the State Anxiety variable and 35 for the Trait Anxiety variable The final value obtained represents the participants anxiety score A score of 0-19 indicates no anxiety 20-39 indicates mild anxiety 40-59 indicates moderate anxiety and 60-79 indicates severe anxiety An average anxiety score of 60 and above suggests that individuals need professional help The Cronbachs alpha reliability coefficient will be calculated for the sample in this research The permission letter for the State-Trait Anxiety Inventory was obtained on June 19 2023 with the signature of Sibel Erenel President of YÖRET Foundation on behalf of Prof Dr Necla Öner
General Comfort Questionnaire GCQ
The General Comfort Questionnaire developed by Katharina Kolcaba underwent a Turkish validation and reliability study conducted by Kuğuoğlu and Karabacak Cronbachs Alpha 85 55-85 for subscales When testing the construct validity of the General Comfort Questionnaire and its sub-dimensions using the Satisfaction scale and its sub-dimensions a significant positive relationship was found between the level of comfort and satisfaction with relaxation procedures r225 p005 satisfaction with nurses r279 p001 satisfaction with physicians r199 p001 satisfaction with auxiliary personnel r198 p001 satisfaction with meals r206 p001 satisfaction with the room r214 p001 and overall satisfaction with the hospital r241 p001 The scale consists of a total of 48 items and is presented in a four-point Likert type The comfort levels of the scale are relief 16 items relaxation 17 items and overcoming problems 15 items The response orders of the scale composed of positive and negative items are given in a mixed manner Accordingly high scores 4 in positive items indicate high comfort and low scores indicate low comfort In the evaluation of the scale the obtained negative scores are reverse coded and summed with positive items The highest total score that can be obtained from the scale is 192 and the lowest total score is 48 A low comfort score is expressed with one point while a high comfort score is represented by four points In Kolcabas study she determined Cronbachs alpha value for internal consistency control as 88 overall and as 66 - 80 for sub-scales The Cronbach alpha reliability coefficient will be calculated for the sample of this study The permission letter for the General Comfort Questionnaire was obtained on June 19 2023 by Prof Dr Ükke Karabacak
Data Analysis For the evaluation of the data obtained in the study the IBM SPSS 230 software package will be utilized Descriptive statistics will be presented using frequencies n and meanstandard deviation Min-Max values Pearson chi-square test and Fishers Exact test will be employed for the analysis of relationships between categorical variables The Shapiro-Wilks test will be used for the analysis of the normality assumption
In cases where the assumption of the normal distribution is not met for the analysis of score differences between the two groups the Mann-Whitney U test will be used when non-parametric and the Students t-test will be applied when parametric For the non-parametric comparison of scores for three or more groups the Kruskal-Wallis test will be utilized and in cases where significance is found the Bonferroni-Dunn test will serve as a post-hoc test If the assumption of normal distribution is met the ANOVA test will be employed for the comparison of scores for three or more groups with the Tukey HSD test for pairwise comparisons
For the analysis of the relationship between the scores of state and trait anxiety subscales and other variables the Pearson correlation test will be conducted when the assumption of normal distribution is satisfied and the Spearman correlation test will be used when it is not met The Cronbachs alpha coefficient will be calculated for the reliability analysis of the scales
A significance level of p005 will be considered in the study
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None