NCT07269340

Brief Summary

In addition to managing drug side effects that arise during cancer treatment, maintaining the patient's psychosocial well-being is also very important. Therefore, the aim of this project is to examine the effect of mandala painting during chemotherapy on anxiety, nausea, and comfort levels. This project aims to reduce the negative effects of chemotherapy, such as nausea, anxiety, and decreased comfort, by distracting the patient's attention through the non-invasive and non-pharmacological practice of mandala coloring in patients undergoing chemotherapy. Mandala painting is a distraction and positive focus practice. A limited number of studies conducted on cancer patients have shown that it reduces distress and improves psychological well-being. However, no study in the literature has comprehensively addressed the symptoms experienced by patients during chemotherapy, such as anxiety, nausea, intense stress, and impaired comfort. The research will be conducted on patients undergoing chemotherapy for the first time, and patients in the experimental group will engage in mandala coloring for at least 30 minutes. Data obtained from assessments conducted before and after chemotherapy will be compared with control group data. This project will provide a more comprehensive assessment of the effect of mandala painting, a non-pharmacological intervention, on the negative symptoms of patients undergoing chemotherapy for the first time. In addition to its scientific contribution, it is believed that effective symptom management can contribute to patients' well-being. Furthermore, if nausea can be controlled, the need for antiemetics during treatment can be reduced. This will also contribute to reducing unwanted drug effects and lowering costs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

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 Progress94%
Sep 2025May 2026

Study Start

First participant enrolled

September 9, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Expected
Last Updated

December 8, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

November 24, 2025

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Anxiety level

    Baseline and post-intervention anxiety level assessed by trained research nurse using Spielberg's State-Trait Anxiety Inventory (STAI). The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety.

    baseline, 60-120 minute

Secondary Outcomes (3)

  • Nausea level

    baseline, 60-120 minute

  • Satisfaction level

    60-120 minute

  • Comfort level

    baseline, 60-120 minute

Study Arms (2)

Mandala Painting

EXPERIMENTAL

Patients receiving chemotherapy for the first time will have mandala painting done during their chemotherapy treatment.

Other: mandala painting

Control Group

NO INTERVENTION

The patients in this group will not receive any intervention and will receive standard treatment and care during chemotherapy.

Interventions

art therapy: mandala painting

Mandala Painting

Eligibility Criteria

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

You may qualify if:

  • \> 18 years old,
  • Receiving chemotherapy for the first time

You may not qualify if:

  • Have a lower education level than secondary school (The STAI is appropriate for those who have at least a sixth-grade reading level),
  • Diagnosed with psychiatric and neurological diseases,
  • Diagnosed with dementia,
  • Received chemotherapy treatment more than once,
  • Planned to receive radiotherapy treatment together with chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ University

Bursa, 16059, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

VomitingAnxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 8, 2025

Study Start

September 9, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations