Clinical trial · Interventional
The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) in Cancer Patients Undergoing Chemotherapy
The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) On the Comfort on Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Blood Pressure | — | UNRESOLVED | — |
| Comfort | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Pulse Rate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smartphone-based virtual reality relaxation (SVR) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SVR group
- description
- Participant in the intervention arm will receive immersive virtual reality intervention in the form of VR box (Shinecon 6.0 VR Box Virtual Reality Glasses with headphones). SVR is virtual relaxation and distraction therapy through a smartphone-based VR device (head-mounted display) which attached to the head of cancer patient during chemotherapy, by displaying a virtual environment of natural panoramas in 360-degree video and combined with traditional and classic musical audio instruments (non-copyright).
- interventionNames
- Device: Smartphone-based virtual reality relaxation (SVR)
- type
- NO_INTERVENTION
- label
- Control group
- description
- In the control group, participants will be given standard care in the form of guided imagery leaflets. It is an information sheets in the form of leaflets about the meaning, benefits, and ways of doing guided imagery relaxation therapy for cancer patient during chemotherapy. RA will guide the participants to practice the guided imagery relaxation therapy listed on the leaflet for ± 10 minutes.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer patients are receiving chemotherapy in all cycles. * Age ≥ 18 years. * Performance status (ECOG Score) 0 - 2. * Ability to understand and sign the informed consent Exclusion Criteria: * Cancer patients with a history of skull structures or cervical spine abnormalities that complicate using VR devices. * Cancer patients with cognitive, visual and hearing impairment, wearing glasses, or having chemo - port. * Patients with a history of epilepsy, seizures, drug and/or drug addiction, vertigo, or visually induced motion sickness.
References
Publications (6)
- BACKGROUNDFabi A, Fotia L, Giuseppini F, Gaeta A, Falcicchio C, Giuliani G, Savarese A, Taraborelli E, Rossi V, Malaguti P, Giannarelli D, Pugliese P, Cognetti F. The immersive experience of virtual reality during chemotherapy in patients with early breast and ovarian cancers: The patient's dream study. Front Oncol. 2022 Sep 30;12:960387. doi: 10.3389/fonc.2022.960387. eCollection 2022. PMID 36249001
- BACKGROUNDBilgic S, Acaroglu R. Effects of Listening to Music on the Comfort of Chemotherapy Patients. West J Nurs Res. 2017 Jun;39(6):745-762. doi: 10.1177/0193945916660527. Epub 2016 Aug 11. PMID 27515501
- BACKGROUNDChan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. PMID 23303884
- BACKGROUNDFaul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. PMID 19897823
- DERIVEDGautama MSN, Haryani H, Huang TW, Chen JH, Chuang YH. Effectiveness of smartphone-based virtual reality relaxation (SVR) for enhancing comfort in cancer patients undergoing chemotherapy: a randomized controlled trial. Support Care Cancer. 2024 Nov 26;32(12):824. doi: 10.1007/s00520-024-09036-7. PMID 39589559
- DERIVEDGautama MSN, Haryani H, Huang TW. Efficacy of smartphone-based virtual reality relaxation in providing comfort to patients with cancer undergoing chemotherapy in oncology outpatient setting in Indonesia: protocol for a randomised controlled trial. BMJ Open. 2023 Jul 25;13(7):e074506. doi: 10.1136/bmjopen-2023-074506. PMID 37491084