NCT07581119

Brief 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. The outcomes will be assessed using standardized scales measuring symptom severity and psychological well-being before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 17, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Mandala coloring,chemotherapy, cancer patients, nausea, vomiting, fatigue, psychological well-being

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    24 hours after intervention

Study Arms (2)

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.

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.

Interventions

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.

The effect of mandala practice on nausea, vomiting, and fatigue

Eligibility Criteria

Age18 Months - 80 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University Vocational School of Health Services

Gaziantep, Şehitkamil, 27000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 41308533BACKGROUND
  • Dadashi 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.

    PMID: 40729075BACKGROUND

MeSH Terms

Conditions

VomitingNauseaFatiguePsychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Adile Neşe

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
experimental and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc prof.

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 12, 2026

Study Start

December 1, 2025

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

May 12, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations