NCT07535021

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
7mo left

Started Jan 2026

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

colorectal cancercope with cancerpsychological resiliencemandala art therapynursing care

Outcome Measures

Primary Outcomes (6)

  • Patient Information Form on experimental group

    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.

    1 day

  • Cognitive Emotional Coping Scale with Cancer pre-test post-test on experimental group

    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.

    1 day

  • Short Psychological Resilience Scale pre-test post-test on experimental group

    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.

    1 day

  • Patient Information Form on control group

    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.

    1 day

  • Cognitive Emotional Coping Scale with Cancer pre-test post-test on control group

    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.

    1 day

  • Short Psychological Resilience Scale pre-test post-test on control group

    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.

    1 day

Study Arms (2)

The application of mandala art therapy to patients undergoing colorectal cancer surgery

EXPERIMENTAL

Colorectal cancer patients

Other: Mandala art therapy

rutine service operation

OTHER

Colorectal cancer patients

Other: rutine service operation

Interventions

Mandala art therapy was applied to the experimental group in the postoperative period.

The application of mandala art therapy to patients undergoing colorectal cancer surgery

No additional intervention will be made to the control group; only data collection forms will be applied.

rutine service operation

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • Over 74 years old,
  • has not completed mandala art therapy application,
  • is not compliant with the application,
  • has a history of previous psychiatric diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Doğan, T. (2015). Kısa Psikolojik Sağlamlık Ölçeği'nin Türkçe uyarlaması: Geçerlik ve güvenirlik çalışması Adaptation of the Brief Resilience Scale into Turkish: A validity and reliability study. Içinde The Journal of Happiness & Well-Being (C. 3, Sayı 1).

    BACKGROUND
  • Cwik, J. C., Vaganian, L., Bussmann, S., Labouvie, H., Houwaart, S., Gerlach, A. L., & Kusch, M. (2021). Assessment of coping with cancer-related burdens: psychometric properties of the Cognitive-Emotional Coping with Cancer scale and the German Mini-mental Adjustment to Cancer scale. Journal of Psychosocial Oncology Research & Practice, 3(1). https://doi.org/10.1097/or9.0000000000000046

    BACKGROUND
  • Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., & Bernard, J. (2008). The brief resilience scale: Assessing the ability to bounce back. International Journal of Behavioral Medicine, 15(3). https://doi.org/10.1080/10705500802222972

    BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsPsychological Well-Being

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPersonal SatisfactionBehavior

Study Officials

  • Melis BOZOGLU

    İstanbul Atlas University

    STUDY DIRECTOR
  • Pınar YILMAZ EKER

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR
  • Ayşegül KAYA İMREK

    Cumhuriyet University

    STUDY DIRECTOR
  • Çağla TOPRAK

    İstanbul Atlas University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised conrtolled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

We plan to publish the study in an international journal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be collected for six months.

Locations