- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435597
Comparing the Effects of Art Therapy and Mandala Application on State Anxiety Levels in Chemotherapy Patients
May 15, 2026 updated by: Dilek Baykal, Atlas University
Comparing the Effects of Art Therapy and Mandala Application on State Anxiety Levels in Chemotherapy Patients: A Randomized Controlled Study
The research is planned as a randomized controlled trial with a two-group (art-based flow drawing and mandala), pre-test, post-test design.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study aims to compare the effects of the "Dance of the Pen" (art-based flow drawing) and mandala activities on state anxiety in patients undergoing chemotherapy and to evaluate intervention satisfaction.
The research is planned as a randomized controlled trial with a two-group, pre-test, post-test design.
The study will be conducted in two hospitals in Istanbul with a total of 60 participants.
The intervention group will receive the "Dance of the Pen" and mandala activities.
Randomization will be based on the patients' chemotherapy session days, and the study will be conducted as a single-blind study.
Data will be collected using a Personal Information Form, the State Anxiety Scale (STAI-I), and a Distress Thermometer.
Interventions will be applied in structured sessions lasting approximately 30-60 minutes.
The population of the study will consist of patients receiving chemotherapy at hospital, and those patients meeting the inclusion criteria will constitute the sample of the study.
Participants will be informed about the study before the research begins.
Those who agree to participate will be assigned to a randomized group and will undergo either the "Dance of the Pen" or "Mandala activity," both conducted as single-session interviews.
Participants will complete a Personal Information Form and the STAI-I before the activity, and will also undergo the STAI-I and distress thermometer tests afterwards.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dilek Baykal, Associate Professor
- Phone Number: +902124443439
- Email: dilek.baykal@atlas.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34000
- Recruiting
- Basaksehir Cam Sakura Hospital
-
Contact:
- Sumeyye Tuncay
- Phone Number: 02124443439
- Email: dilek.baykal@atlas.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- -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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandala
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.
|
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.
|
|
Experimental: Art therapy
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.
|
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.
|
|
No Intervention: Control group
Participants will only receive the clinical procedure.
The clinical procedure will be an information session about the treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State anxiety scale
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2026
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Study Registration Dates
First Submitted
February 18, 2026
First Submitted That Met QC Criteria
February 23, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Atlas University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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