Clinical trial NCT06263257: The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients
Official title: The Effect of Mandala Art Therapy on Anxiety and Comfort Levels in Living Kidney Transplant Recipients: A Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Transplant;Failure,Kidney
Transplant Complication
Keywords: kidney transplant
art therapy
anxiety
comfort
Randomized Controlled Trial
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, 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.
Primary purpose: SUPPORTIVE_CARE

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.

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 www.randomizer.org, 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, Cronbach's Alpha (Internal Consistency) coefficient for the State Anxiety Scale is indicated as 0.73-0.86, and for the Trait Anxiety Scale, it is 0.86-0.93. The scale was adapted to Turkish and validated by Öner and Le Compte. The reliability of the scale was reported as Cronbach's Alpha coefficient of 0.83-0.92 for the State Anxiety Scale and 0.86-0.92 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 participant's 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 Cronbach's 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. (Cronbach's 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 (r=.225, p\<0.05), satisfaction with nurses (r=.279, p\<0.01), satisfaction with physicians (r=.199, p\<0.01), satisfaction with auxiliary personnel (r=.198, p\<0.01), satisfaction with meals (r=.206, p\<0.01), satisfaction with the room (r=.214, p\<0.01), and overall satisfaction with the hospital (r=.241, p\<0.01). 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 Kolcaba's study, she determined Cronbach's 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 23.0 software package will be utilized. Descriptive statistics will be presented using frequencies (n%) and mean±standard deviation (Min-Max) values. Pearson chi-square test and Fisher's 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 Student's 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 Cronbach's alpha coefficient will be calculated for the reliability analysis of the scales.

A significance level of p\<0.05 will be considered in the study.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Being a kidney transplant recipient
* Willing to participate voluntarily in the study
* Having person, place, and time orientation
* Undergoing kidney transplant for the first time

Exclusion Criteria:

* Having a diagnosed psychiatric illness
* Having a physical disability that would hinder drawing

Primary outcomes:
measure: Reduction in anxiety levels
timeFrame: First Measurement (Day Before Surgery): Second Measurement (Postoperative Day 5 - Discharge Day): Third Measurement (1 Month after Surgery - 3rd Control): The data will be reported six months after the completion of the data collection process.
measure: Increasing comfort level
timeFrame: First Measurement (Day Before Surgery): Second Measurement (Postoperative Day 5 - Discharge Day): Third Measurement (1 Month after Surgery - 3rd Control): The data will be reported six months after the completion of the data collection process.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
Study officials:
affiliation: Akdeniz University
name: Büşra Nur Temür, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Nilgün Aksoy, PhD
role: STUDY_DIRECTOR
References:
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citation: Abbing A, Ponstein A, van Hooren S, de Sonneville L, Swaab H, Baars E. The effectiveness of art therapy for anxiety in adults: A systematic review of randomised and non-randomised controlled trials. PLoS One. 2018 Dec 17;13(12):e0208716. doi: 10.1371/journal.pone.0208716. eCollection 2018.
citation: Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.