Cancer and Chemotherapy Related AnemiaAVR-CHEMONCT07152938
Augmented Virtual Reality for Reducing Pain, Stress, Anxiety and Improve Self Efficacy in Adult Cancer Patients Undergoing Chemotherapy in The West Bank
A study testing AVR Group (Chemotherapy + AVR) in people with Cancer and Chemotherapy Related Anemia and Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), run by Arab American University (Palestine) at 3 sites in Palestinian Territories.
Trial summary
The main purpose of this study is to examine the effect of using AVR on pain, stress, anxiety, and SE among adult cancer patients undergoing chemotherapy in the West Bank hospitals in Palestine. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer and Chemotherapy Related Anemia, Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
- What is being tested?
- AVR Group (Chemotherapy + AVR)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesPalestinian Territories
- Study dates
- 1 Jun 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-60 years undergoing chemotherapy for breast or colon cancer.
- Stage I or II cancer, as defined by the study protocol.
- Manageable levels of pain, anxiety, and stress, appropriate for participation in the intervention.
- -
Who cannot join
- Age over 60 years.
- Cancer types other than breast or colon cancer.
- Severe pain, anxiety, or stress that could interfere with participation or require intensive care beyond the study scope.
Trial locations and contacts
3 sites in 1 country.
Palestinian Territories3 sites
Jenin governmental hospital
Jenin, 00970
AL-Watni governmental hospital
Nablus, 00970
Thabet Thabet governmental hospital
Tulkarm, 00970
About this study
Official title: The Effect of Using Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy Among Adult Cancer Patients Undergoing Chemotherapy in the West Bank
The main purpose of this study is to examine the effect of using AVR on pain, stress, anxiety, and SE among adult cancer patients undergoing chemotherapy in the West Bank hospitals in Palestine. The main questions it aims to answer are:
- What is the effect of AVR therapy on pain levels score compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the stress levels compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the anxiety compared with routine care during chemotherapy session among cancer patients?
- 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).
Read the detailed description
This study was designed as a randomized control trial (RCT), including both pretest and posttest assessments.
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
- Numeric Pain Rating Scale (NPRS): This scale was developed for assessing the pain scale.
- Perceived Stress Scale (PSS-10) The Perceived Stress Scale (PSS-10)
- Generalized Anxiety disorder (GAD-7) The GAD-7 A brief measure for assessing generalized anxiety disorder: the GAD-7.
- 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
- Cancer and Chemotherapy Related Anemia, Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
- Being tested
- AVR Group (Chemotherapy + AVR)
- Keywords
- Augmented Virtual Reality, Pain Management, Stress, Anxiety, Self-Efficacy, Chemotherapy, Palestine
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lymphoma, Multiple Myeloma, Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVR Group (Chemotherapy + AVR)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Chemotherapy Care) | No intervention | 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. |
| AVR Group | Experimental | Patients receive standard chemotherapy care plus Augmented Virtual Reality (AVR) distraction sessions during chemotherapy infusion. Receives: Behavioral: AVR Group (Chemotherapy + AVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity during chemotherapy
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. The outcome will be the change in NPRS score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
Measured: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Secondary outcomes (3)
Change in self-efficacy during chemotherapy
Self-efficacy will be measured using the General Self-Efficacy Scale (GSE). The GSE consists of 10 items, each scored from 1 (not at all true) to 4 (exactly true), with total scores ranging from 10 to 40. Higher scores indicate greater self-efficacy. The outcome will be the change in GSE score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
Measured: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Change in perceived stress during chemotherapy
Stress will be measured using the Perceived Stress Scale (PSS-10). The PSS-10 consists of 10 items, each scored from 0 (never) to 4 (very often), with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress. The outcome will be the change in PSS-10 score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
Measured: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Change in anxiety symptoms during chemotherapy
Anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms. The outcome will be the change in GAD-7 score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
Measured: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer and Chemotherapy Related AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants randomly assigned to either the intervention group(augmented virtual reality sessions)or the other control group( standard care)
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Salih Abu lie, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152938
- Sponsor's protocol ID
- AAUP-AVR-ONCO-2025
- Acronym
- AVR-CHEMO
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data did not shared due to patient privacy concerns and the absence of a secure data repository. Only aggregated and anonymized study results made available in publications and presentations
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy Among Adult Cancer Patients Undergoing Chemotherapy in the West Bank
- ClinicalTrials.gov ID
- NCT07152938
- Acronym / sponsor ID
- AVR-CHEMO / AAUP-AVR-ONCO-2025
- Conditions
- Cancer and Chemotherapy Related Anemia, Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
- Keywords
- Augmented Virtual Reality, Pain Management, Stress, Anxiety, Self-Efficacy, Chemotherapy, Palestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to examine the effect of using AVR on pain, stress, anxiety, and SE among adult cancer patients undergoing chemotherapy in the West Bank hospitals in Palestine. The main questions it aims to answer are:
- What is the effect of AVR therapy on pain levels score compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the stress levels compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the anxiety compared with routine care during chemotherapy session among cancer patients?
- 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).
Detailed description
This study was designed as a randomized control trial (RCT), including both pretest and posttest assessments.
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
- Numeric Pain Rating Scale (NPRS): This scale was developed for assessing the pain scale.
- Perceived Stress Scale (PSS-10) The Perceived Stress Scale (PSS-10)
- Generalized Anxiety disorder (GAD-7) The GAD-7 A brief measure for assessing generalized anxiety disorder: the GAD-7.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants randomly assigned to either the intervention group(augmented virtual reality sessions)or the other control group( standard care)
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Chemotherapy Care) | No intervention | –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. |
| AVR Group | Experimental | Behavioral: AVR Group (Chemotherapy + AVR)Patients receive standard chemotherapy care plus Augmented Virtual Reality (AVR) distraction sessions during chemotherapy infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients aged 18-60 years undergoing chemotherapy for breast or colon cancer.
- Stage I or II cancer, as defined by the study protocol.
- Manageable levels of pain, anxiety, and stress, appropriate for participation in the intervention.
- -
Key exclusion criteria (3 listed)
- Age over 60 years.
- Cancer types other than breast or colon cancer.
- Severe pain, anxiety, or stress that could interfere with participation or require intensive care beyond the study scope.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | AVR Group |
Primary outcome
Change in pain intensity during chemotherapy
Time frame: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. The outcome will be the change in NPRS score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
3 secondary outcomes
Change in self-efficacy during chemotherapy
Time frame: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Change in perceived stress during chemotherapy
Time frame: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Change in anxiety symptoms during chemotherapy
Time frame: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data did not shared due to patient privacy concerns and the absence of a secure data repository. Only aggregated and anonymized study results made available in publications and presentations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVR Group (Chemotherapy + AVR) in people with Cancer and Chemotherapy Related Anemia and Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), run by Arab American University (Palestine) at 3 sites in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity during chemotherapy (time frame: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.