NCT07464626

Brief Summary

This randomized controlled trial aims to evaluate the effects of virtual reality-based art therapy and physical art therapy on anxiety, psychological well-being, and sleep quality in patients with colorectal cancer receiving outpatient chemotherapy. A total of 78 patients will be randomly assigned to three groups: a virtual reality art therapy group, a physical art therapy group, and a control group. Participants in the intervention groups will receive art therapy sessions every two weeks for eight weeks (four sessions in total). Anxiety, psychological well-being, and sleep quality will be assessed using validated scales before the intervention and after the fourth session. The findings are expected to contribute to the development of non-pharmacological supportive care interventions for oncology patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Mar 2026

Typical duration 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

Study Progress23%
Mar 2026Dec 2027

Study Start

First participant enrolled

March 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 7, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

Art TherapyVirtual Reality Art TherapyPsychological Well-beingSleep QualityCancer Supportive CareNon-pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Anxiety Level

    Anxiety levels will be assessed using the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale consists of 7 items with scores ranging from 0 to 21. Higher scores indicate higher levels of anxiety.

    Baseline and after completion of the fourth intervention session (8 weeks)

Secondary Outcomes (2)

  • Change in Psychological Well-being

    Baseline and after completion of the fourth intervention session (8 weeks)

  • Change in Sleep Quality

    Baseline and after completion of the fourth intervention session (8 weeks)

Study Arms (3)

Virtual Reality Art Therapy

EXPERIMENTAL

Participants in this group will receive virtual reality-based art therapy using a virtual reality headset and motion controllers. Patients will create drawings in a virtual painting environment using the Vermillion VR painting application. Sessions will be conducted every two weeks for eight weeks, for a total of four sessions.

Behavioral: Virtual Reality Art Therapy

Physical Art Therapy

EXPERIMENTAL

Participants in this group will receive traditional art therapy sessions using colored pencils and paper. Sessions will be conducted every two weeks for eight weeks, for a total of four sessions.

Behavioral: Physical Art Therapy

Control Group

NO INTERVENTION

Participants in this group will receive routine care without art therapy interventions. Outcome measurements will be collected at baseline and at the end of the study period.

Interventions

Participants will engage in art-making activities using a virtual reality headset and motion controllers. The Vermillion VR painting application will be used to allow participants to create drawings in an immersive virtual environment. Each session will last approximately 30 minutes and will be conducted every two weeks for a total of four sessions.

Virtual Reality Art Therapy

Participants will engage in structured art-making activities using colored pencils and paper. Each participant will receive standard drawing materials and will be guided through therapeutic drawing exercises aimed at promoting emotional expression and stress reduction. Each session will last approximately 30 minutes and will be conducted every two weeks for a total of four sessions.

Physical Art Therapy

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, Balçova, 35330, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Kaimal G, Ray K, Muniz J. Reduction of cortisol levels and participants' responses following art making. Art Therapy. 2016;33(2):74-80.

    BACKGROUND
  • Hacmun I, Regev D, Solomon V. Art therapy in virtual reality: A qualitative study of art therapists' perspectives. Frontiers in Psychology. 2021.

    BACKGROUND
  • Jiang XH, Chen XJ, Xie QQ, et al. Effects of art therapy in cancer care: A systematic review and meta-analysis. European Journal of Cancer Care. 2020;29:e13277.

    BACKGROUND
  • Bosman JT, Bood ZM, Scherer-Rath M, et al. The effects of art therapy on anxiety, depression, and quality of life in adults with cancer: A systematic literature review. Supportive Care in Cancer. 2021;29:2289-2298.

    BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsDiseaseAnxiety DisordersParasomniasPsychological Well-BeingSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersSleep Wake DisordersNervous System DiseasesPersonal SatisfactionBehaviorSleep Disorders, IntrinsicDyssomnias

Central Study Contacts

Esra Uslu Tanis, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, participants and researchers cannot be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to three parallel groups: a virtual reality art therapy group, a physical art therapy group, and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 11, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations