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

NCT05756465 | Completed

• 1 other identifier: 12117
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief 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

Comfort; Pain; Anxiety; Blood Pressure; Pulse Rate

Keywords

Immersive virtual reality; Comfort; Cancer patient; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• the Shortened General Comfort Questionnaire

  Subjective responses of cancer patients during one session of chemotherapy administration (regardless of how many chemotherapy cycles, for instance in the first cycle, second cycle and so on) in four dimensions of comfort including physical, social, psychospiritual, and environmental are measured using a questionnaire. It measure using the Shortened General Comfort Questionnaire in Indonesian version. The questionnaire consists of 28 statement items with a Likert scale and an assessment score from 1 (strongly disagree) to 6 (strongly agree). The highest total score from the comfort instrument is 168 and the lowest is 28. The higher scores indicate higher level of comfort.

  Change from baseline the Shortened General Comfort Questionnaire at immediately after one session of chemotherapy (regardless of drug administration duration)

Secondary Outcomes (4)

• Evaluation of Anxiety

  T0: Baseline data collection T1: 10 minutes before chemotherapy premedication; T2: 10 minutes before start the intervention; T3: immediately after received intervention; T4: 60 minutes after drugs administration is completed.

• Evaluation of Pain

  T0: Baseline data collection T1: 10 minutes before chemotherapy premedication; T2: 10 minutes before start the intervention; T3: immediately after received intervention; T4: 60 minutes after drugs administration is completed.

• Evaluation of Pulse rate

  T0: Baseline data collection T1: 10 minutes before chemotherapy premedication; T2: 10 minutes before start the intervention; T3: immediately after received intervention; T4: 60 minutes after drugs administration is completed.

• Evaluation of Blood pressure (systolic blood pressure and diastolic blood pressure)

  T0: Baseline data collection T1: 10 minutes before chemotherapy premedication; T2: 10 minutes before start the intervention; T3: immediately after received intervention; T4: 60 minutes after drugs administration is completed.

Study Arms (2)

SVR group

EXPERIMENTAL

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).

Device: Smartphone-based virtual reality relaxation (SVR)

Control group

NO INTERVENTION

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.

Interventions

Smartphone-based virtual reality relaxation (SVR) DEVICE

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.

SVR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Taipei Medical University: collaborator

Study Sites (2)

Universitas Gadjah Mada

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

Dr Sardjito General Hospital

Yogyakarta, 55512, Indonesia

Location

Related Publications (6)

• Fabi 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 BACKGROUND

• Bilgic 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 BACKGROUND

• Chan 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 BACKGROUND

• Faul 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 BACKGROUND

• Gautama 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 DERIVED

• Gautama 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 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Made Satya Nugraha N Gautama, Master

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (Nurse who appointed by researcher to be responsible for collection of outcome data) and data analysts will be blinded from participant allocation. This blinding is carried out, due to the technical nature of VR interventions, making it difficult to blind study participant during the intervention, thus to minimize the potential for methodological bias, the study must blind the outcome assessor or data analysts.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master of Nursing Program, Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

Model Details: This study is a two-arm parallel randomised controlled trial with a 1:1 allocation. This study divided two groups, namely the intervention group in the form of SVR therapy with the installation of a VR device (head-mounted display/HMD) on the respondent's head during chemotherapy. The control group received standard care through leaflets containing instructions for relaxation techniques with image visualization as guided imagery therapy. The group's determination, apart from randomization, will also use envelope concealment and outcome assessor will be blinded during data collection. The protocol is composed according to Standard Protocol Items: Recommendations for Interventional Trials and its checklist

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: March 6, 2023
• Study Start: March 27, 2023
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)