NCT07088367

Brief Summary

The main questions this study aims to answer are: Does VR meditation, delivered through virtual reality glasses and the MediboothVR application, effectively reduce anxiety in cancer patients during chemotherapy? Is there a meaningful difference in anxiety reduction between the VR intervention groups and the control group? Researchers will compare two intervention groups using VR glasses-one with guided meditation and one with calming video content-to a control group receiving standard care, to see if there are differences in anxiety levels. Participants will: Be randomly assigned to one of three groups Attend their scheduled chemotherapy sessions Depending on group assignment, either: Use VR glasses with the MediboothVR meditation app for 10 minutes daily Use VR glasses to watch calming 360-degree nature videos for 10 minutes daily Receive standard care with no VR use All participants will complete anxiety questionnaires and have their vital signs recorded before and after each session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2024

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

April 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

June 12, 2025

Last Update Submit

July 20, 2025

Conditions

Keywords

canceranxiety

Outcome Measures

Primary Outcomes (1)

  • State Anxiety

    Change in State Anxiety Score Anxiety levels will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S), a validated self-report tool. The STAI-S consists of 20 items. Each item is rated on a 4-point Likert scale (1 = Not at all, 4 = Very much so). Total scores range from 20 to 80, with higher scores indicating greater anxiety. Participants will complete the STAI-S before and after each VR session (or standard care, in the control group) on three consecutive days. This outcome will evaluate daily changes in state anxiety levels, and whether the intervention (VR meditation or VR video) leads to a significant reduction in anxiety compared to control.

    Immediately Before and after each intervention session, on Day 1, Day 2, and Day 3 (total of 6 measurement points)

Secondary Outcomes (7)

  • Trait Anxiety

    Day 1 (baseline, before the first intervention),Day 3 (after the last intervention session), andDay 30 (follow-up assessment)

  • Virtual Reality Sickness

    Immediately after each VR session on Day 1, Day 2, and Day 3

  • Participant Satisfaction with VR Intervention

    Immediately after each VR session on Day 1, Day 2, and Day 3

  • Participant's Heart Rate

    Immediately before and after each VR session on Day 1, Day 2, and Day 3.

  • Participant's Respiratory Rate

    Immediately before and after each VR session on Day 1, Day 2, and Day 3.

  • +2 more secondary outcomes

Study Arms (3)

Virtual reality meditation group

EXPERIMENTAL

Participants in this group will use a virtual reality (VR) headset to complete a 10-minute meditation session on three consecutive days. A different meditation video will be used each day, and sessions will be held between 10:00 AM and 12:00 PM. The meditation sessions are provided through the "MediboothVR" application. This app is the first immersive virtual reality meditation tool developed in Türkiye and supports the Turkish language. In MediboothVR, participants experience a 360-degree guided meditation in a virtual environment. Each video starts with a short environmental scene, followed by a visual journey to a meditation space where a guiding silhouette appears and leads the participant through the session. Each session lasts approximately 10 minutes.

Behavioral: Virtual reality meditation

Virtual Reality Video Group

ACTIVE COMPARATOR

This group will use a VR headset on three consecutive days between 10:00 AM and 12:00 PM. Instead of meditation, participants will watch 360-degree nature videos. A different video (10 minute) will be shown each day. The purpose is to create a calming, immersive experience without guided meditation.

Behavioral: Virtual Reality Videos

Control Group

NO INTERVENTION

Participants in the control group will receive standard nursing care without any VR intervention.

Interventions

This intervention involves immersive virtual reality (VR)-based guided meditation sessions using MediboothVR, the first Turkish-language supported virtual reality meditation application developed in Türkiye. It is distinct from other VR interventions in the following ways: Cultural and language adaptation: MediboothVR is fully available in Turkish, providing culturally relevant audio-guided content. This makes it more accessible and emotionally resonant for Turkish-speaking participants, unlike many VR applications designed in other languages. Duration and consistency: The intervention is delivered over three consecutive days, with a different video used each day, each lasting approximately 10 minutes. Technical delivery: The application is used exclusively via VR headsets, creating a fully immersive experience that eliminates visual and auditory distractions from the hospital environment.

Virtual reality meditation group

This intervention involves the use of a virtual reality headset to present immersive 360-degree calming nature videos to participants. It is distinct from other video- or relaxation-based interventions in several key ways: Delivery via VR headset: Unlike standard video-based relaxation interventions presented on screens or tablets, this method delivers video content in a fully immersive virtual reality environment, which blocks out external visual and auditory stimuli from the unit. Non-guided and passive exposure: The video group receives no audio-guided instruction or meditation scripting, making it a purely visual and passive exposure intervention. Cultural relevance and visual neutrality: The nature videos are non-verbal, visually neutral, and free of religious, symbolic, or emotionally provocative imagery, allowing them to be suitable for a diverse patient population.

Virtual Reality Video Group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or older,
  • Sufficient communication ability to respond to study questions,
  • Receiving outpatient treatment for at least three consecutive days with a confirmed cancer diagnosis,
  • Scoring 40 or above on the State Anxiety Inventory (STAI-S), indicating moderate or higher anxiety levels,
  • Voluntarily agreeing to participate in the study.

You may not qualify if:

  • Inability to speak or understand Turkish,
  • Being under contact isolation precautions,
  • Presence of active eye discharge or visual impairment,
  • History of seizures, epilepsy, or hypersensitivity to flashing lights,
  • History of vertigo or motion sickness,
  • Experiencing active nausea or vomiting,
  • Having wounds or dressings on the head or face that interfere with the use of a VR headset,
  • Hearing impairment,
  • Hypersensitivity of the face or scalp to light pressure,
  • Diagnosis of psychiatric conditions that may affect participation (e.g., schizophrenia, severe psychosis),
  • Diagnosis of recurrent or relapsed cancer,
  • Scoring below 40 on the State Anxiety Inventory,
  • Previous use of virtual reality applications,
  • Prior experience with meditation practices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Uslu A, Arslan S. The Effect of Using Virtual Reality Glasses on Anxiety and Fatigue in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Pretest-Posttest Randomized Controlled Study. Semin Oncol Nurs. 2023 Oct;39(5):151503. doi: 10.1016/j.soncn.2023.151503. Epub 2023 Sep 22.

    PMID: 37741768BACKGROUND
  • Franklin, D. M., Silvestro, C., Carrillo, R. A., Yang, Y., Annadurai, D., Ganesan, S., Vasantham, D. S. J., Mettu, S., Patel, M., Patil, M. S., & Akurathi, N. D. (2023). The impact of meditation aided by VR technology as an emerging therapeutic to ease cancer related anxiety, stress, and fatigue. Frontiers in Virtual Reality, 4(July), 1-12. https://doi.org/10.3389/frvir.2023.1195196

    BACKGROUND
  • Wu Y, Wang N, Zhang H, Sun X, Wang Y, Zhang Y. Effectiveness of Virtual Reality in Symptom Management of Cancer Patients: A Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2023 May;65(5):e467-e482. doi: 10.1016/j.jpainsymman.2023.01.023. Epub 2023 Feb 8.

    PMID: 36758907BACKGROUND
  • Chow H, Hon J, Chua W, Chuan A. Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. J Pain Symptom Manage. 2021 Feb;61(2):384-394. doi: 10.1016/j.jpainsymman.2020.08.016. Epub 2020 Aug 19.

    PMID: 32822755BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersNeoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 12, 2025

First Posted

July 28, 2025

Study Start

April 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

July 28, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. Results will be reported at the group level in scientific publications.

Locations