Anxiety Clinical Trial
Official title:
The Effect of Mandala Art Therapy on Anxiety and Comfort Levels in Living Kidney Transplant Recipients: A Mixed-Methods Study
NCT number | NCT06263257 |
Other study ID # | 2023-631 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 13, 2024 |
Est. completion date | April 2025 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | April 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University Hospital | Antalya |
Lead Sponsor | Collaborator |
---|---|
Busra Nur Temur |
Turkey,
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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. |
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