Augmented Virtual Reality for Reducing Pain, Stress, Anxiety and Improve Self Efficacy in Adult Cancer Patients Undergoing Chemotherapy in The West Bank
NCT ID: NCT07152938
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2023-06-01
2023-10-30
Brief Summary
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1. What is the effect of AVR therapy on pain levels score compared with routine care during chemotherapy session among cancer patients?
2. What is the effect of AVR therapy on the stress levels compared with routine care during chemotherapy session among cancer patients?
3. What is the effect of AVR therapy on the anxiety compared with routine care during chemotherapy session among cancer patients?
4. What is the effect of AVR therapy on the general SE compared with routine care during chemotherapy session among cancer patients?
The participants divided into two groups, the intervention group, which receives AVR, and the control group, which receives standard treatment. The study used a pretest and posttest design to assess the effect of AVR on the study variables (pain, stress, anxiety and self-efficacy).
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Detailed Description
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Participants were randomly assigned to either the intervention group, which received AR, or the control group, which received standard treatment. Random assignment was conducted using a computer-generated list of patients scheduled for chemotherapy, with patients alternately assigned to the intervention and control group (e.g., patient number 1 to the intervention group, number 2 to the control group). This process was managed by a nurse who was blinded to the study protocol. Due to the nature of the study, the researchers were not blinded.
The study was conducted in three large hospitals in northern Palestine that specialized in oncology care, particularly within their chemotherapy units.
The sample consisted of cancer patients undergoing chemotherapy in the aforementioned hospitals. Pretests, interventions, and posts were conducted .Inclusion criteria were cancer patients (over 18 years old) who required chemotherapy and could provide informed consent in Arabic. Exclusion criteria included a history of VR motion sickness, physical or cognitive limitations preventing VR headset use, visual, auditory, or vestibular impairments, uncontrolled severe medical conditions (e.g., vomiting, nausea, respiratory depression), pediatric patients, cognitive impairments, and any mental or psychological disorders.
Questionnaires were used to gather the data. It consists of three sections:
Sociodemographic data: composed of age gender, resident area, marital status, type of cancer, number of chemotherapy sessions, and medical data
the variables assessed used the below tool
1. Numeric Pain Rating Scale (NPRS):
This scale was developed for assessing the pain scale.
2. Perceived Stress Scale (PSS-10) The Perceived Stress Scale (PSS-10)
3. Generalized Anxiety disorder (GAD-7) The GAD-7 A brief measure for assessing generalized anxiety disorder: the GAD-7.
4. General Self-Efficacy Scale (GSE) The scale is designed to assess a person's optimistic self-beliefs used to cope with life's demands
Data Collection Process Data were collected from June to September 2023. Ethical approval was obtained from the Arab American University and the Palestinian Ministry of Health. The data collection process began with a meeting with the head of the chemotherapy unit to compile a list of eligible patients. Randomization ensured equal chance of participants for all eligible patients
The study was conducted in two phases to prevent contamination between groups:
Phase one (Control Group): Patients received routine chemotherapy sessions without VR. Before and after the sessions, they completed the pre and post-test questionnaires.
Phase two (Intervention Group): patients received VR during their chemotherapy sessions. Pre and post-test questionnaires were administered before and after the VR sessions.
Both groups completed the questionnaires during their regular visits to the chemotherapy units. The post-intervention assessment measured levels of stress and anxiety using the same questionnaires as the pretest.
Once participants prepared for chemotherapy infusion, investigator provided them with the VR headset with a brief overview of how the hardware worked. This includes details on how to navigate the interface, and which apps were available for use during the intervention. Participants completed a brief survey through a self-administered questionnaire to assess their levels of stress and anxiety. The participants chose to experience which video they would like to watch mountains, rivers, sea, and mountain falls.
Participants were provided with a Meta Quest 2 headset (KW49CM), equipped with high-resolution displays and paired with the Meta-Quest iOS app (version 192.0). Patients were given a brief overview of how to use the hardware and could choose from soothing virtual environments such as mountains, rivers, and waterfalls.
A pilot study was conducted on 15 patients meeting the study criteria. The pilot aimed to test the feasibility and reliability of the study design.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Group (Standard Chemotherapy Care)
the control group participated in routine sessions without AVR. Patients were admitted to the daycare unit, where a cannula was applied. The nurse then followed the doctor's order for the type of medication that would be given to the patient. Subsequently, the patients filled out the questionnaire at the posttest.
No interventions assigned to this group
AVR Group
Patients receive standard chemotherapy care plus Augmented Virtual Reality (AVR) distraction sessions during chemotherapy infusion.
AVR Group (Chemotherapy + AVR)
the intervention group received AVR before they started treatment and during the session. The researcher administered the posttest questionnaire The questionnaire assessed immediately after finishing AVR. Participants informed not to discuss AVR with each other's, as the researcher explained to the participants the purpose of the study and their participation will not affect their care or treatment
Interventions
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AVR Group (Chemotherapy + AVR)
the intervention group received AVR before they started treatment and during the session. The researcher administered the posttest questionnaire The questionnaire assessed immediately after finishing AVR. Participants informed not to discuss AVR with each other's, as the researcher explained to the participants the purpose of the study and their participation will not affect their care or treatment
Eligibility Criteria
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Inclusion Criteria
2. Stage I or II cancer, as defined by the study protocol.
3. Manageable levels of pain, anxiety, and stress, appropriate for participation in the intervention.
\-
Exclusion Criteria
2. Cancer types other than breast or colon cancer.
3. Severe pain, anxiety, or stress that could interfere with participation or require intensive care beyond the study scope.
18 Years
60 Years
ALL
No
Sponsors
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Arab American University (Palestine)
OTHER
Responsible Party
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Farid Salih Abu lie
academic lecturer
Locations
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Jenin governmental hospital
Jenin, , Palestinian Territories
AL-Watni governmental hospital
Nablus, , Palestinian Territories
Thabet Thabet governmental hospital
Tulkarm, , Palestinian Territories
Countries
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Other Identifiers
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AAUP-AVR-ONCO-2025
Identifier Type: -
Identifier Source: org_study_id
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