NCT06844695

Brief Summary

Symptom management is the most important aspect of clinical cancer care. Virtual reality-based interventions can be used to improve cancer patients' experiences with medical treatment, with their distraction-based effects. The aim of this study was to determine the effects of virtual museum visits with virtual reality glasses on pain, fatigue, and anxiety in patients receiving chemotherapy. The study included a museum visit with virtual reality glasses during the procedure in addition to routine treatments for patients in the intervention group. Patients in the control group were given only their routine treatments. Data will be collected using the Personal Information Form (PIF), Hirai Cancer Fatigue Scale, Visual Analog Scale (VAS) and Beck Anxiety Scale (BAÖ). In the first interview, the patient was also presented with virtual museum options and the museums he/she wanted to visit were listed. In addition, the patients in the Intervention Group were shown virtual museums with 53 different themes on the website prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, which is located on the website ''https://sanalmuze.gov.tr'' belonging to the Ministry of Culture and Tourism, and the museums they wanted to visit in each session according to their preferences were listed. In the meantime, the Intervention Group was explained how to use the virtual glasses and they will be tested. One week after the first test, the patients in the Intervention Group will visit a virtual museum on the theme preferred by the patients using virtual glasses for an average of 20 minutes for a total of five consecutive weeks. In the fifth virtual tour session, which is the third and last application session, measurements (Visual Analog Scale, Hirai Cancer Fatigue Scale and Beck Anxiety Scale) will be administered. The control group will not receive any intervention other than routine treatment.The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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 12, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

January 21, 2026

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 14, 2025

Last Update Submit

January 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Hirai Cancer Fatigue Scale

    The scale, originally named "Hirai Cancer Fatigue Scale", was developed by Kazue Hirai et al. in 2015 and consisted of 15 items . The scale is used to measure fatigue in cancer patients and has a 5-point Likert design. Each item on the scale is evaluated as 1 "not at all", 2 "very little", 3 "a little", 4 "a lot", and 5 "very much". It has 3 sub-dimensions (Physical-Mental, Activity-Related Sensitivity, and Cognitive Sensitivity). Items 1-6 on the scale constitute the Physical-Mental Sub-Dimension, items 7-12 constitute the Activity-Related Sensitivity Sub-Dimension, and items 12-15 constitute the Cognitive Sensitivity Sub-Dimension. The scale has no cut-off point. The minimum value of the scale is 15 and the maximum value is 75, with high scores indicating increased fatigue, while low scores indicating less fatigue. The validity and reliability study in our country was conducted by Mencel.

    It will take 5 weeks to collect data three times after randomization is done. The first measurement of fatigue scale will be done in the first week, the second measurement in the third week and the third measurement in the fifth week of virtual muse

  • Visual Analog Scale (VAS)

    VAS, which evaluates the intensity of pain, is widely used in adults. The scale was developed by Price et al. as a scale consisting of a single 10 mm line that evaluates the intensity of pain. The two end definitions of the parameter to be evaluated are written at both ends of the line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line, putting a dot, or pointing. For example, for pain, no pain is written at one end and very severe pain is written at the other end and the patient marks his/her current condition on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain. It has been shown that the line on which the test is applied is not affected by whether it is horizontal or vertical or by its length. The average of the values obtained for the patients is taken.

    It will take 5 weeks to collect data three times after randomization is done. The first measurement of VAS will be done in the first week, the second measurement in the third week and the third measurement in the fifth week of virtual museum visit.

  • Beck Anxiety Inventory (BAI)

    The inventory was developed by Beck et al. to determine the level and frequency of anxiety symptoms experienced by individuals. The scale has a Likert design with self-assessment consisting of 21 items and is scored between 0-3. The high total score indicates the high level of anxiety experienced by the individual. The score range varies between 0-63. The scale is evaluated as 0-7 points, no anxiety symptoms, 8-15 points, mild anxiety, 16-25 points, moderate anxiety, 26-63 points, and severe anxiety symptoms. The validity and reliability study in our country was conducted by Ulusoy et al.

    It will take 5 weeks to collect data three times after randomization is done. The first measurement of BAI will be done in the first week, the second measurement in the third week and the third measurement in the fifth week of virtual museum visit.

Study Arms (2)

Experimental: Art Therapy Intervention Group

EXPERIMENTAL

The Intervention Group is informed about how to use the virtual glasses and is tested. One week after the first test, the patients in the Intervention Group visit a virtual museum on the theme of the patients' choice for an average of 20 minutes using virtual glasses for a total of five consecutive weeks. In the fifth virtual tour session, which is the third and final application session, measurements (Visual Analog Scale, Hirai Cancer Fatigue Scale and Beck Anxiety Scale) are made in both groups.

Other: Art Therapy (Virtual Museum Visit)

No Intervention: Control Group

NO INTERVENTION

No virtual museum visit was applied to the control group. Scales were applied to individuals. For the control group, evaluations were made with scales three times in total.

Interventions

Virtual Reality (VR) is a technology that creates simulated settings in which users can interact and experience as if they were physically there.Virtual Reality typically involves the use of a headset or glasses that display the virtual environment, as well as other input devices such as controllers or gloves that allow users to interact with the virtual world

Experimental: Art Therapy Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having not visited a virtual museum with VR glasses before,
  • Having no difficulty in communicating,
  • Having no mental problems, being 18 years of age or older,
  • Agreeing to participate in the study

You may not qualify if:

  • Having Stage IV cancer
  • Having difficulty seeing and communicating.
  • Being under the age of 18
  • The desire to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mukadder

Mollaoğlu, Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (3)

  • Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

    PMID: 3204199BACKGROUND
  • Hirai K, Kanda K, Takagai J, Hosokawa M. Development of the Hirai Cancer Fatigue Scale: Testing its reliability and validity. Eur J Oncol Nurs. 2015 Aug;19(4):427-32. doi: 10.1016/j.ejon.2014.12.004. Epub 2015 Feb 2.

    PMID: 25656217BACKGROUND
  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PMID: 6226917BACKGROUND

MeSH Terms

Conditions

Cancer PainFatigueAnxiety Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 25, 2025

Study Start

December 12, 2023

Primary Completion

March 12, 2025

Study Completion

May 30, 2025

Last Updated

January 21, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
25 May 2025

Locations