NCT07435597

Brief Summary

The research is planned as a randomized controlled trial with a two-group (art-based flow drawing and mandala), pre-test, post-test design.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

February 18, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

mandalaart therapyoncologychemotherapy

Outcome Measures

Primary Outcomes (1)

  • State anxiety scale

    The State Anxiety Scale will be administered prior to the intervention, followed by randomly assigned art therapy or mandala practice. The State Anxiety Scale and distress thermometer will be administered again after the intervention is completed. A high score on the State Anxiety Scale indicates high anxiety levels.

    6 months

Study Arms (3)

Mandala

EXPERIMENTAL

Patients will be given a file containing mandala designs, and they will be asked to color the design of their choice with their preferred colored pencils (pastel, crayon, marker) throughout the treatment.

Other: Mandala therapy

Art therapy

EXPERIMENTAL

During chemotherapy, the patient will be given a pen and will be played music. Following instructions, they will be asked to draw on the paper with their eyes closed and then interpret the drawing.

Other: Art therapy

Control group

NO INTERVENTION

Participants will only receive the clinical procedure. The clinical procedure will be an information session about the treatment.

Interventions

During chemotherapy, the patient will be given a pen to hold with their eyes closed and asked to draw on a blank piece of paper according to the instructions. Afterwards, their drawing will be analyzed and interpreted.

Art therapy

Patients will be given a file containing mandala designs, and they will be asked to color the design of their choice with their preferred colored pencils (pastel, crayon, marker) throughout the treatment.

Mandala

Eligibility Criteria

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

You may qualify if:

  • Must be 18 years of age or older
  • Must be receiving chemotherapy treatment
  • Must be willing to participate in the research
  • Must be literate
  • Must be able to speak and understand Turkish

You may not qualify if:

  • Having any speech or comprehension impairment
  • Being treated with other forms of treatment
  • Having any accompanying psychiatric diagnosis
  • Using any psychiatric medication
  • Being enrolled in another program using a similar method could affect the study's outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam Sakura Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Dilek Baykal, Associate Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 27, 2026

Study Start

February 18, 2026

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations