The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients

NCT06263257 | Completed DMC

• 1 other identifier: 2023-631
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Transplant;Failure,Kidney; Transplant Complication

Keywords

kidney transplant; art therapy; anxiety; comfort; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Reduction in anxiety levels

  The first outcome is the change of continuous and situational anxiety levels in live kidney transplant recipients. 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. 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. 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.

  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.

• Increasing comfort level

  The second outcome is a change in the comfort levels of live kidney transplant recipients. General Comfort Questionnaire (GCQ) The scale consists 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 (1) 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.

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

for the intervention group, the first measurement (afternoon of the day before surgery-T1) will include State-Trait Anxiety Inventory (STAI) and General Comfort Questionaire (GCQ), the second measurement (1 week after surgery-T2) 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 T2 (after the scales), Session 2 on 1st Control (2 week after surgery), Session 3 on 2nd Control (3 weeks after surgery-T3), and the third measurement at 3rd Control (3 weeks after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire.

Behavioral: Mandala Art Therapy

Control Group

NO INTERVENTION

After obtaining consent from eligible participants within the scope of the study, the first measurement (STAI and GCQ) will be conducted on the afternoon of the preoperative day. Participants in this group will not be aware of their group assignment. The second measurement will be taken on postoperative day 5, the day of discharge (SAI and GCQ). The third measurement will be carried out during the participant's 3rd check-up after discharge (one month after surgery) for both STAI and GCQ. The intervention group's program will be shared with the control group participants on a voluntary basis after their discharge.

Interventions

Mandala Art Therapy BEHAVIORAL

In art therapy, visual arts (such as drawing, painting, and sculpting) can be used as a tool to facilitate the expression of emotions and enhance coping skills. Naisin and colleagues (2006) reported that a one-hour art therapy session significantly reduced anxiety levels in hospitalized adult oncology patients. The word "mandala" is now typically associated with circular, geometric designs and often appears in adult coloring books aimed at promoting mindfulness and stress reduction. However, the methodology and theory of Jung related to mandalas are based not only on coloring pre-drawn templates but also on the activity of creating mandalas. The act of creating a mandala is claimed to provide immediate benefits in improving mood. The mandala is expressed as an instantaneous outward expression of the inner world of the person drawing it.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Busra Nur Temur: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (3)

• Mantzios M, Giannou K. When Did Coloring Books Become Mindful? Exploring the Effectiveness of a Novel Method of Mindfulness-Guided Instructions for Coloring Books to Increase Mindfulness and Decrease Anxiety. Front Psychol. 2018 Jan 30;9:56. doi: 10.3389/fpsyg.2018.00056. eCollection 2018.

  PMID: 29441038 BACKGROUND

• 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.

  PMID: 30557381 BACKGROUND

• 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.

  PMID: 16488349 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Büşra Nur Temür, M.Sc.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Nilgün Aksoy, PhD

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Intervention group, the first measurement (afternoon of the day before surgery-T1) will include State-Trait Anxiety Inventory (STAI) and General Comfort Questionaire (GCQ), the second measurement (1 week after surgery-T2) 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 T2 (after the scales), Session 2 on 1st Control (2 week after surgery), Session 3 on 2nd Control (3 weeks after surgery-T3), and the third measurement at 3rd Control (3 weeks after surgery) (State Anxiety Inventory (STAI) and General Comfort Questionaire (GCQ).

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 16, 2024
• Study Start: March 13, 2024
• Primary Completion: September 12, 2025
• Study Completion: September 19, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and any additional supporting information are planned to be shared in January 2025.
• Access Criteria: The IPD and any additional supporting information will be shared with qualified researchers and analysts for specific types of analyses. Requests for access will be reviewed by Büşra Nur Temür based on established criteria, ensuring compliance with ethical and research guidelines

Locations

TU (1)