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Not Yet Recruiting NCT05756465

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

Conditions: Comfort, Self Efficacy, Pain, Anxiety, Blood Pressure, Pulse Rate

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 80
Sponsor: Gadjah Mada University

Location: Indonesia

Summary

The aim of this trial study is to identify the effect of S-VR on comfort and self-efficacy of symptom management in 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)

Eligibility Criteria

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 consentExclusion 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05756465). StuddyBuddy aggregates publicly available trial information.