Colorectal CancerNCT07535021
The Effect of Mandala Art Therapy, Psychological Resilience, Coping With Cancer, Colorectal Cancer Surgery
A study testing Mandala art therapy and rutine service operation in people with Colorectal Cancer and Coping, Cognitive, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Coping, Cognitive, Psychological Well-Being
- What is being tested?
- Mandala art therapy and rutine service operation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To communicate,
- Aged 18 or older,
- Agreed to participate
- Scheduled for colorectal cancer surgery.
- No physical disability of the upper extremities,
- no visual problems,
Show all 9Show fewer
- 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,
Who cannot join
- Over 74 years old,
- has not completed mandala art therapy application,
- is not compliant with the application,
- has a history of previous psychiatric diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas
PINAR YILMAZ EKER, Asst. Prof. Dr., +90 530 946 89 19, yilmazpinar20@gmail.com
About this study
Official title: The Effect of Mandala Art Therapy on Psychological Resilience and Coping With Cancer in Patients Undergoing Colorectal Cancer Surgery: a Prospective Randomized Controlled Study.
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.
Read more
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.
- Being tested
- Mandala art therapy, rutine service operation
- Keywords
- colorectal cancer, cope with cancer, psychological resilience, mandala art therapy, nursing care
- Medical subject headings
- Colorectal Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala art therapyOther
Mandala art therapy was applied to the experimental group in the postoperative period.
rutine service operationOther
No additional intervention will be made to the control group; only data collection forms will be applied.
| Study group | Role | What they receive |
|---|---|---|
| The application of mandala art therapy to patients undergoing colorectal cancer surgery | Experimental | Colorectal cancer patients Receives: Other: Mandala art therapy |
| rutine service operation | Other | Colorectal cancer patients Receives: Other: rutine service operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised conrtolled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar YILMAZ EKER, Cumhuriyet University
- Investigators
- Melis BOZOGLU, Study director, İstanbul Atlas UniversityPınar YILMAZ EKER, Principal investigator, Cumhuriyet UniversityAyşegül KAYA İMREK, Study director, Cumhuriyet UniversityÇağla TOPRAK, Study director, İstanbul Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535021
- Sponsor's protocol ID
- 2025-10/45
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish the study in an international journal.
Publications
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).
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
Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy on Psychological Resilience and Coping With Cancer in Patients Undergoing Colorectal Cancer Surgery: a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07535021
- Acronym / sponsor ID
- 2025-10/45
- Keywords
- colorectal cancer, cope with cancer, psychological resilience, mandala art therapy, nursing care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised conrtolled trial
| Arm | Type | Receives |
|---|---|---|
| The application of mandala art therapy to patients undergoing colorectal cancer surgery | Experimental | Other: Mandala art therapyColorectal cancer patients |
| rutine service operation | Other | Other: rutine service operationColorectal cancer patients |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To communicate,
- Aged 18 or older,
- Agreed to participate
- Scheduled for colorectal cancer surgery.
- No physical disability of the upper extremities,
Key exclusion criteria (4 listed)
- Over 74 years old,
- has not completed mandala art therapy application,
- is not compliant with the application,
- has a history of previous psychiatric diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala art therapyMandala art therapy was applied to the experimental group in the postoperative period. | Other | The application of mandala art therapy to patients undergoing colorectal cancer surgery |
| rutine service operationNo additional intervention will be made to the control group; only data collection forms will be applied. | Other | rutine service operation |
Primary outcome
Patient Information Form on experimental group
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.
Cognitive Emotional Coping Scale with Cancer pre-test post-test on experimental group
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.
Short Psychological Resilience Scale pre-test post-test on experimental group
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.
Patient Information Form on control group
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.
Cognitive Emotional Coping Scale with Cancer pre-test post-test on control group
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.
Short Psychological Resilience Scale pre-test post-test on control group
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- BackgroundDoğan, 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).
- BackgroundCwik, 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: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Individual participant dataSharing planned: Yes. We plan to publish the study in an international journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melis BOZOGLU study director
İstanbul Atlas University
Pınar YILMAZ EKER principal investigator
Cumhuriyet University
Ayşegül KAYA İMREK study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala art therapy and rutine service operation in people with Colorectal Cancer and Coping, Cognitive, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pınar YILMAZ EKER (+90 530 946 89 19, yilmazpinar20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form on experimental group (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535021, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.