Sivas Cumhuriyet University
Sivas, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07535021
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.
Interested in participating?
Request Info18 year–74 year
All sexes
Interventional
Not applicable
Sivas, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mandala art therapy was applied to the experimental group in the postoperative period.
No additional intervention will be made to the control group; only data collection forms will be applied.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ayşegül KAYA İMREK
CONTACT
Pınar YILMAZ EKER
CONTACT
Cumhuriyet University
Other
The Effect of Mandala Art Therapy on Psychological Resilience and Coping With Cancer in Patients Undergoing Colorectal Cancer Surgery: a Prospective Randomized Controlled Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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