The Effect of Mandala Art Therapy on Psychological Resilience and Coping With Cancer in Patients Undergoing Colorectal Cancer Surgery: a Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patient Information Form on experimental group
研究概览
简要总结
The aim of this study is to evaluate the effects of mandala art therapy on psychological resilience and coping with cancer in patients undergoing colorectal cancer surgery.
This study was conducted as a randomized controlled trial with a pre-test-post-test design, including intervention and control groups. The study will be conducted between January 2026 and December 2026 with patients undergoing colorectal cancer surgery. The G.power 3.1.9.7 program was used for sample size calculation. The sample size was determined as 28 individuals in each group, considering equal sample sizes in the experimental and control groups, a 95% confidence interval (type I error 5%), and statistical power of 80% (type II error 20%) with an effect size of d=0.50. However, considering a possible 20% data loss, 35 individuals will be included in each group, resulting in a total sample size of 70 individuals.
Sample selection will be made using sequential sampling according to inclusion criteria. Patients will then be randomly assigned to the experimental group (A) and the control group (B) using block randomization (four-block). First, 15 blocks of four, such as AABB, ABAB, ABBA, BBAA, BABA, BAAB, etc., will be prepared by the researcher and statistician. Individuals will then be divided into two groups according to the prepared list; this process will be repeated continuously until the sample size is complete.
Three data collection forms were used. SPSS 22.00 software package was used for data analysis. Skewness and kurtosis analyses were performed to determine the normality of the data distribution. Frequency (n) and percentage (%) distributions were calculated to determine the sociodemographic and clinical characteristics of the participants. Independent samples t-test was used to determine the mean differences between two independent groups, dependent samples t-test was used to compare pre- and post-intervention measurements, and repeated measures one-way analysis of variance (ANOVA) was used. Cohen's d effect size was calculated to evaluate the significance of the difference between groups in terms of the intervention. The statistical significance level was accepted as p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
This study will utilize a sequential sampling method. Patients will then be randomly assigned to the experimental group (A) and the control group (B) using block randomization (four-block). First, 15 blocks of four, such as AABB, ABAB, ABBA, BBAA, BABA, BAAB, etc., will be prepared by the researcher and statistician. Individuals will then be divided into two groups according to the prepared list; this process will be repeated continuously until the sample size is complete.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To communicate,
- •Aged 18 or older,
- •Agreed to participate
- •Scheduled for colorectal cancer surgery.
- •No physical disability of the upper extremities,
- •no visual problems,
- •no history of psychotic drug use,
- •pain intensity and fatigue level ≤3 points according to VAS-10 before MST application,
- •will be hospitalized for 3 days postoperatively,
排除标准
- •Over 74 years old,
- •has not completed mandala art therapy application,
- •is not compliant with the application,
- •has a history of previous psychiatric diagnosis.
研究组 & 干预措施
The application of mandala art therapy to patients undergoing colorectal cancer surgery
Colorectal cancer patients
干预措施: Mandala art therapy (Other)
rutine service operation
Colorectal cancer patients
干预措施: rutine service operation (Other)
结局指标
主要结局
Patient Information Form on experimental group
时间窗: 1 day
The form includes personal information such as age, gender, marital status, education level, employment status, smoking, and alcohol use; and clinical information such as family history of cancer, loss of life due to cancer, stage of cancer diagnosis, stoma placement, and metastasis status.
Cognitive Emotional Coping Scale with Cancer pre-test post-test on experimental group
时间窗: 1 day
The scale consists of 21 items and 5 sub-dimensions (cognitive avoidance, cognitive re-evaluation, distraction and suppression, optimism and hope, uncontrollable thoughts) and is a 6-point Likert scale. The scale is answered as follows: "Strongly Disagree" (0), "Disagree" (1), "Partially Disagree" (2), "Partially Agree" (3), "Agree" (4), "Strongly Agree" (5) (Appendix-2). The minimum score on the scale is 0 and the maximum score is 105. It is known that as the score on the scale increases, the coping abilities of individuals also increase.
Short Psychological Resilience Scale pre-test post-test on experimental group
时间窗: 1 day
The scale measures psychological resilience. The scale is prepared in a 5-point Likert type and contains 6 items. The scale is answered as follows: "Not suitable at all" (1), "Not suitable" (2), "Somewhat suitable" (3), "Suitable" (4), The answer is "Completely Appropriate" (5). Items 2, 4 and 6 on the scale are reverse coded. A high score on the scale indicates high psychological resilience.
Patient Information Form on control group
时间窗: 1 day
The form includes personal information such as age, gender, marital status, education level, employment status, smoking, and alcohol use; and clinical information such as family history of cancer, loss of life due to cancer, stage of cancer diagnosis, stoma placement, and metastasis status.
Cognitive Emotional Coping Scale with Cancer pre-test post-test on control group
时间窗: 1 day
The scale consists of 21 items and 5 sub-dimensions (cognitive avoidance, cognitive re-evaluation, distraction and suppression, optimism and hope, uncontrollable thoughts) and is a 6-point Likert scale. The scale is answered as follows: "Strongly Disagree" (0), "Disagree" (1), "Partially Disagree" (2), "Partially Agree" (3), "Agree" (4), "Strongly Agree" (5) (Appendix-2). The minimum score on the scale is 0 and the maximum score is 105. It is known that as the score on the scale increases, the coping abilities of individuals also increase.
Short Psychological Resilience Scale pre-test post-test on control group
时间窗: 1 day
The scale measures psychological resilience. The scale is prepared in a 5-point Likert type and contains 6 items. The scale is answered as follows: "Not suitable at all" (1), "Not suitable" (2), "Somewhat suitable" (3), "Suitable" (4), The answer is "Completely Appropriate" (5). Items 2, 4 and 6 on the scale are reverse coded. A high score on the scale indicates high psychological resilience.
次要结局
未报告次要终点
研究者
Pınar YILMAZ EKER
Asst. Prof. Dr.
Cumhuriyet University