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The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) in Cancer Patients Undergoing Chemotherapy

NCT05756465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-06-24

No results posted yet for this study

Summary

The aim of this trial study is to identify the effect of S-VR on comfort on cancer patients undergoing chemotherapy. Additional objectives of this study include: (a) identifying the effect of S-VR on anxiety in chemotherapy patients; (b) identifying the effect of S-VR on pain intensity of chemotherapy patients; (c) identifying the effect of S-VR on vital signs (pulse and blood pressure) of chemotherapy patients. Participants is randomly assigned into two group: SVR intervention group and control group. In the SVR group, participants will use a VR device (head-mounted display/HMD) with 360-degree natural panoramic and music relaxation contents. Control group will receive standard care in the form of guided imagery leaflet.

The research will adhere to the ethical standards outlined in the Declaration of Helsinki and its subsequent amendments, as well as the protocol under reviewed by Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada - Dr. Sardjito General Hospital Yogyakarta (Approval Number: KE/FK/0301/EC/2023). A formal informed consent will be obtained from all study participants. Validation number: 63f81182672f3 (http://komisietik.fk.ugm.ac.id/validasi)

Conditions

Interventions

DEVICE

Smartphone-based virtual reality relaxation (SVR)

SVR is virtual relaxation and distraction therapy through a smartphone-based VR device (head-mounted display) that is attached to the head of a cancer patient undergoing chemotherapy, displaying a virtual environment of natural panoramas in 360-degree video and combined with traditional and classic musical instruments. SVR device is paired with smartphone using operating system either Android (minimum generation 11, Android 4.4 KitKat) or OS version 12, minimum screen size of 5.5-inch and maximum of 6.0-inch, screen resolution of at least 1080 x 1920 pixels, can connect to WIFI/ internet and provides a YouTube app to access 360-degree videos. SVR content uses original 360o videos produced by researchers using a video editor software for ± 10 minutes duration.

Sponsors & Collaborators

  • Taipei Medical University

    collaborator OTHER

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • Made Satya Nugraha N Gautama, Master · Gadjah Mada University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2023-05-30
Completion
2023-07-30

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756465 on ClinicalTrials.gov