Pain Clinical Trial
Official title:
The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) On the Comfort and Self-Efficacy of Symptom Management Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
NCT number | NCT05756465 |
Other study ID # | 12117 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 27, 2023 |
Est. completion date | July 30, 2023 |
Verified date | September 2023 |
Source | Gadjah Mada University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 99 |
Est. completion date | July 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Universitas Gadjah Mada | Sleman | Yogyakarta |
Indonesia | Dr Sardjito General Hospital | Yogyakarta |
Lead Sponsor | Collaborator |
---|---|
Gadjah Mada University | Taipei Medical University |
Indonesia,
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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The questionnaire of Self-Efficacy of Cancer Symptom Self-Management Scale | The ability and confidence of cancer patients in implementing symptom management behavior after one session of chemotherapy administration (regardless of how many chemotherapy cycles, for instance in the first cycle, second cycle and so on) are measured using a questionnaire. It is measured using the Self-Efficacy of Cancer Symptom Self-Management Scale (SE-CSSMS) in Indonesian version. The instrument consists of 6 question items with a score range of 1-10. The higher scores indicate higher level of self-efficacy of symptom management. | Change from baseline the questionnaire of Self-Efficacy of Cancer Symptom Self-Management Scale at immediately after one session of chemotherapy (regardless of drug administration duration) | |
Secondary | Evaluation of Anxiety | Transitory emotional reactions of cancer patients that arise in situations during one session of chemotherapy administration (regardless of how many chemotherapy cycles, for instance in the first cycle, second cycle and so on) which is perceived as threatening, were measured using a questionnaire. It is measured using the Visual Analog Scale for Anxiety (VAS - A). The scale consisted of a 100-mm horizontal line, embedded on the left by the words ''not at all anxious'' and on the right by ''extremely anxious.'' A higher score indicated greater 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. | |
Secondary | Evaluation of Pain | Cancer patients' unpleasant sensory and emotional sensations occur during one session of chemotherapy administration (regardless of how many chemotherapy cycles, for instance in the first cycle, second cycle and so on) due to cancer diagnosis, invasive procedures, and acute side effects of cytotoxic agents. It is measured using the Numerical Rating Pain Scale (NPS). Pain intensity items are scored using an 11-point numeric rating scale. A higher score indicated greater 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. | |
Secondary | Evaluation of Pulse rate | Pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute in cancer patients before intravenous access, before receiving the intervention, immediately after the intervention, and after one session of chemotherapy administration is completed. Adults' regular resting heart rate ranges from 60 to 100 beats per minute. It is measured by using automatic digital sphygmomanometer. | 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. | |
Secondary | Evaluation of Blood pressure (systolic blood pressure and diastolic blood pressure) | Blood pressure is as objective measurement are measured by using automatic digital sphygmomanometer. BP is the force exerted by circulating blood against the walls of the body's arteries, the main blood vessels in the body in cancer patients who will be given intravenous access, before receiving the intervention, immediately after the intervention, and after one session of chemotherapy administration is completed. A systolic pressure above 90 mm Hg and less than 120 mm Hg, and a diastolic pressure between 60 mm Hg and less than 80 mm Hg. | 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. |
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