Chemotherapy-Induced Nausea and Vomiting (CINV)MANDALACHEMONCT07581119
Effect of Mandala Coloring on Nausea, Fatigue, and Well-Being in Chemotherapy Patients
A study testing Mandala Coloring Intervention in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. The intervention involves guided mandala coloring sessions applied during chemotherapy cycles. Read more about this study
- Who is it for?
- Ages 18 to 80 months
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- What is being tested?
- Mandala Coloring Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adult patients diagnosed with cancer Patients receiving chemotherapy treatment Age 18 years and older Patients who are able to communicate verbally Patients who agree to participate in the study and sign informed consent form Patients without cognitive impairment
Who cannot join
- Patients with severe psychiatric disorders Patients with visual or cognitive impairments preventing participation in mandala coloring Patients in critical clinical condition or intensive care unit Patients who refuse to continue participation Patients receiving additional concurrent psychological interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Vocational School of Health Services
Gaziantep, Şehitkamil, 27000
About this study
Official title: The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
This study aims to evaluate the effect of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. The intervention involves guided mandala coloring sessions applied during chemotherapy cycles. The outcomes will be assessed using standardized scales measuring symptom severity and psychological well-being before and after the intervention.
Read the detailed description
This study is a clinical trial designed to investigate the effects of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. Chemotherapy is commonly associated with both physical and psychological side effects that negatively impact patients' quality of life.
The intervention consists of structured mandala coloring sessions conducted during chemotherapy cycles. Participants will perform the coloring activity in a calm and appropriate clinical environment. No pharmacological or additional psychological interventions will be applied during the study period.
Outcome measures include the severity of nausea, vomiting, and fatigue, as well as psychological well-being levels, assessed using validated scales at baseline and after the intervention. Differences in these outcomes will be analyzed to evaluate the effectiveness of the mandala coloring intervention.
The study is expected to provide evidence regarding low-cost, non-pharmacological supportive care methods that may improve symptom management and psychological health in chemotherapy patients.
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- Being tested
- Mandala Coloring Intervention
- Keywords
- Mandala coloring,chemotherapy, cancer patients, nausea, vomiting, fatigue, psychological well-being
- Medical subject headings
- Vomiting, Nausea, Fatigue, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Coloring InterventionOther
Participants in the intervention group performed a structured mandala coloring activity designed to promote relaxation and reduce chemotherapy-related symptoms. Pre-designed mandala patterns and colored pencils were provided. The session was conducted in a quiet environment and lasted approximately 20-30 minutes. The intervention was applied once. Outcomes including nausea, vomiting, fatigue, and psychological well-being were assessed within 24 hours after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| The effect of mandala practice on nausea, vomiting, and fatigue | Experimental | Cancer patients receiving chemotherapy in this group participated in a structured mandala painting intervention in addition to standard care. The intervention was applied during chemotherapy infusion and continued within the first 24 hours after treatment. Patients engaged in individual coloring activities using standardized mandala templates in a calm environment aimed at promoting relaxation and reducing symptom burden. Receives: Other: Mandala Coloring Intervention |
| Control: Standard Care | No intervention | Patients in this group received standard chemotherapy care only without any additional non-pharmacological intervention. Outcomes such as nausea, vomiting, fatigue, and psychological well-being were assessed for comparison with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Nausea and vomiting severity were assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). Fatigue levels were measured using a standardized fatigue scale, and psychological well-being was assessed using a validated psychological well-being scale. Outcome measures were compared between the mandala painting group and the control group before and within 24 hours after the intervention.
Measured: Within 24 hours after the intervention
The effects of mandala painting on nausea, vomiting, fatigue, and psychological well-being in cancer patients undergoing chemotherapy.
Fatigue Severity Questionnaire: The fatigue severity scale is a unidimensional questionnaire with a total score of 16 on a seven-point Likert scale, and higher total scores indicate greater fatigue.
Psychological Well-being Scale: The scale consists of 8 items and is a 7-point Likert type. The scale is single-dimensional, with a minimum score of 8 and a maximum score of 56. Higher scores on the scale indicate higher overall psychological well-being.
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Dec 2025
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as an interventional study using a parallel assignment design. The mandala coloring intervention was applied to participants during the chemotherapy treatment process and within a 24-hour period. Participants in the intervention group received mandala coloring activities in addition to routine care. In the control group, no intervention was applied, and only assessment tools were administered. Outcome measures were evaluated within a 24-hour period following the intervention, and comparisons were made between the groups.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adile Nese, University of Gaziantep
- Investigators
- Adile Neşe, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581119
- Sponsor's protocol ID
- Mandala Coloring Chemotherapy
- Acronym
- MANDALACHEMO
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuruk E, Todil T, Askan F, Kara M, Hacisalihoglu A. Effects of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children and youth receiving outpatient chemotherapy. J Pediatr Nurs. 2026 Jan-Feb;86:366-374. doi: 10.1016/j.pedn.2025.11.029. Epub 2025 Nov 26.
PubMed 41308533Dadashi N, Khanali Mojen L, Ilkhani M, Nasirie M, Mirzaee HR, Boozaripour M. Effect of Mandala Art Therapy on Quality of Life in Breast Cancer Patients. Asian Pac J Cancer Prev. 2025 Jul 1;26(7):2533-2540. doi: 10.31557/APJCP.2025.26.7.2533.
PubMed 40729075
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT07581119
- Acronym / sponsor ID
- MANDALACHEMO / Mandala Coloring Chemotherapy
- Keywords
- Mandala coloring,chemotherapy, cancer patients, nausea, vomiting, fatigue, psychological well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 12 May 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.
This study aims to evaluate the effect of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. The intervention involves guided mandala coloring sessions applied during chemotherapy cycles. The outcomes will be assessed using standardized scales measuring symptom severity and psychological well-being before and after the intervention.
Detailed description
This study is a clinical trial designed to investigate the effects of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. Chemotherapy is commonly associated with both physical and psychological side effects that negatively impact patients' quality of life.
The intervention consists of structured mandala coloring sessions conducted during chemotherapy cycles. Participants will perform the coloring activity in a calm and appropriate clinical environment. No pharmacological or additional psychological interventions will be applied during the study period.
Outcome measures include the severity of nausea, vomiting, and fatigue, as well as psychological well-being levels, assessed using validated scales at baseline and after the intervention. Differences in these outcomes will be analyzed to evaluate the effectiveness of the mandala coloring intervention.
The study is expected to provide evidence regarding low-cost, non-pharmacological supportive care methods that may improve symptom management and psychological health in chemotherapy patients.
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Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted as an interventional study using a parallel assignment design. The mandala coloring intervention was applied to participants during the chemotherapy treatment process and within a 24-hour period. Participants in the intervention group received mandala coloring activities in addition to routine care. In the control group, no intervention was applied, and only assessment tools were administered. Outcome measures were evaluated within a 24-hour period following the intervention, and comparisons were made between the groups.
| Arm | Type | Receives |
|---|---|---|
| The effect of mandala practice on nausea, vomiting, and fatigue | Experimental | Other: Mandala Coloring InterventionCancer patients receiving chemotherapy in this group participated in a structured mandala painting intervention in addition to standard care. The intervention was applied during chemotherapy infusion and continued within the first 24 hours after treatment. Patients engaged in individual coloring activities using standardized mandala templates in a calm environment aimed at promoting relaxation and reducing symptom burden. |
| Control: Standard Care | No intervention | –Patients in this group received standard chemotherapy care only without any additional non-pharmacological intervention. Outcomes such as nausea, vomiting, fatigue, and psychological well-being were assessed for comparison with the experimental group. |
Who may qualify
- Ages
- 18 to 80 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adult patients diagnosed with cancer Patients receiving chemotherapy treatment Age 18 years and older Patients who are able to communicate verbally Patients who agree to participate in the study and sign informed consent form Patients without cognitive impairment
Key exclusion criteria (1 listed)
- Patients with severe psychiatric disorders Patients with visual or cognitive impairments preventing participation in mandala coloring Patients in critical clinical condition or intensive care unit Patients who refuse to continue participation Patients receiving additional concurrent psychological interventions
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 Coloring InterventionParticipants in the intervention group performed a structured mandala coloring activity designed to promote relaxation and reduce chemotherapy-related symptoms. Pre-designed mandala patterns and colored pencils were provided. The session was conducted in a quiet environment and lasted approximately 20-30 minutes. The intervention was applied once. Outcomes including nausea, vomiting, fatigue, and psychological well-being were assessed within 24 hours after the intervention. | Other | The effect of mandala practice on nausea, vomiting, and fatigue |
Primary outcome
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Time frame: Within 24 hours after the intervention
Nausea and vomiting severity were assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). Fatigue levels were measured using a standardized fatigue scale, and psychological well-being was assessed using a validated psychological well-being scale. Outcome measures were compared between the mandala painting group and the control group before and within 24 hours after the intervention.
The effects of mandala painting on nausea, vomiting, fatigue, and psychological well-being in cancer patients undergoing chemotherapy.
Time frame: 24 hours after intervention
Fatigue Severity Questionnaire: The fatigue severity scale is a unidimensional questionnaire with a total score of 16 on a seven-point Likert scale, and higher total scores indicate greater fatigue. Psychological Well-being Scale: The scale consists of 8 items and is a 7-point Likert type. The scale is single-dimensional, with a minimum score of 8 and a maximum score of 56. Higher scores on the scale indicate higher overall psychological well-being.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 41308533Yuruk E, Todil T, Askan F, Kara M, Hacisalihoglu A. Effects of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children and youth receiving outpatient chemotherapy. J Pediatr Nurs. 2026 Jan-Feb;86:366-374. doi: 10.1016/j.pedn.2025.11.029. Epub 2025 Nov 26.
- Background: PubMed 40729075Dadashi N, Khanali Mojen L, Ilkhani M, Nasirie M, Mirzaee HR, Boozaripour M. Effect of Mandala Art Therapy on Quality of Life in Breast Cancer Patients. Asian Pac J Cancer Prev. 2025 Jul 1;26(7):2533-2540. doi: 10.31557/APJCP.2025.26.7.2533.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Adile Neşe principal investigator
University of Gaziantep
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 Coloring Intervention in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by University of Gaziantep 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy (time frame: Within 24 hours after the intervention). The study lists 2 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 NCT07581119, which also lists 2 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 8 Oct 2026.