The Effect of Mandala Art Therapy on Anxiety and Comfort Levels in Living Kidney Transplant Recipients: A Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Increasing comfort level
研究概览
简要总结
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.
详细描述
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-T1) will include State Anxiety Inventory (SAI) 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). For the Control Group, the third measurement (3 weeks 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 (4 weeks after surgery).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Having a diagnosed psychiatric illness
- •Having a physical disability that would hinder drawing
研究组 & 干预措施
Intervention Group
for the intervention group, the first measurement (afternoon of the day before surgery-T1) will include State Anxiety Inventory (SAI) 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.
干预措施: Mandala Art Therapy (Behavioral)
Control Group
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.
结局指标
主要结局
Increasing comfort level
时间窗: 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.
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.
Reduction in anxiety levels
时间窗: 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.
The first outcome is the change of continuous and situational anxiety levels in live kidney transplant recipients. The State Anxiety Inventory (SAI) was developed to assess state anxiety in research and clinical applications. This scale consists of two subscales, State Anxiety 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. 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.
次要结局
未报告次要终点
研究者
Busra Nur Temur
Research Assistant
Akdeniz University