Pain ManagementNCT07085065
Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies
A study testing VR session in people with Pain Management and Anxiety, run by Yesmine Amara at 1 site in Tunisia.
Trial summary
The goal of this clinical trial] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question[s] it aims to answer are: Does VR effectively reduce pain during painful procedures for patients with… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pain Management, Anxiety, Procedures
- What is being tested?
- VR session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- being ≥ 6 years old
- having a confirmed diagnosis of a hematological malignancy
- undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.
Who cannot join
- unstable or photosensitive epilepsy
- hearing, visual, or inner ear impairments
- severe psychiatric, cognitive, or mental disorders
- Contagious diseases
- Communication difficulties
- Patients who withdraw consent
- Patient who remove the VR headset during the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia
Tunis, Sfax Governorate, 3002
Yesmine Amara (principal investigator), PhD student, 00 216 50 260 564, yesmine.amara8@gmail.com
About this study
Official title: Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial
The goal of this clinical trial] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question[s] it aims to answer are:
Does VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session).
External control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.
Read the detailed description
This study is a prospective interventional crossover trial designed to evaluate the efficacy of Virtual Reality during painful procedures, including Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous studies have suggested that virtual reality (VR) can distract patients from painful stimuli, enhance the quality of healthcare, and improve overall patient well-being.
- Conditions
- Pain Management, Anxiety, Procedures, Hematological Neoplasms
- Being tested
- VR session
- Keywords
- Virtual Reality, Pain, Anxiety, Hematological Malignancies, Invasive procedures, Chemotherapy
- Medical subject headings
- Agnosia, Anxiety Disorders, Hematologic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR sessionDevice
Also called Standard care
Standard care: Standard care. In both the external control group and the intervention group during Period 1, painful procedures will be performed ccording to usual clinical practice by trained healthcare professionals.
VR session: The device includes a VR headset connected to a smartphone, which displays immersive visual content, along with headphones that deliver audio content. Scenarios are culturally and demographically adapted to the study population. The duration of each VR session will correspond to the time required for each painful procedure.
| Study group | Role | What they receive |
|---|---|---|
| internal control design | Experimental | The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session during the same procedure). Receives: Device: VR session |
| external control group | Active comparator | This arm consists of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups. Receives: Device: VR session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels using the Numeric Rating Scale (0-10)
The Numeric rating scale (NRS) of pain is a scale from 0 to 10, where scores from 0 to 3 indicate mild pain, 4 to 6 indicate moderate pain, and 7 to 10 indicate severe pain. The NRS has been proven valid and reliable for measuring cancer-related pain. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care, VR session)
Measured: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
Secondary outcomes (1)
Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2)
The Spielberger Trait Anxiety Inventory measures an individual's general tendency to experience anxiety across various situations. This inventory reflects a stable personality trait, meaning some individuals are more prone to anxiety than others. It will be measured at Baseline The Spielberger State Anxiety Inventory assesses anxiety as a temporary emotional state or condition triggered by a specific situation or stimulus. This scale measures "here and now" anxiety, which can fluctuate in intensity. The STAI-Y1 consists of 20 items, with scores ranging from 20 to 80, evaluated on a 4-point Likert scale (ranging from "Not at all" to "Completely"). Higher scores on both subscales indicate higher levels of anxiety. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care and VR session)
Measured: Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Feb 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session). In addition to this internal control design, the study will also include an external control group consisting of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yesmine Amara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sfax
- Responsible party
- Sponsor-investigator, Yesmine Amara, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085065
- Sponsor's protocol ID
- FMS-2025-VR1024
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amara Y, Ben Mahmoud L, Ammar M, Zghal K, Hakim A, Elloumi M, Mdhaffar M, Frikha I. Evaluation of the impact of virtual reality as a non-pharmacological intervention for pain and anxiety during hematology procedures and chemotherapy: a controlled trial. Future Sci OA. 2026 Dec;12(1):2746758. doi: 10.1080/20565623.2026.2746758. Epub 2026 Oct 16.
PubMed 42885483
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07085065
- Acronym / sponsor ID
- FMS-2025-VR1024
- Conditions
- Pain Management, Anxiety, Procedures, Hematological Neoplasms
- Keywords
- Virtual Reality, Pain, Anxiety, Hematological Malignancies, Invasive procedures, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Yesmine AmaraUniversity, hospital or other
- Collaborators
- University of Sfax
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Jul 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 goal of this clinical trial] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question[s] it aims to answer are:
Does VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session).
External control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.
Detailed description
This study is a prospective interventional crossover trial designed to evaluate the efficacy of Virtual Reality during painful procedures, including Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous studies have suggested that virtual reality (VR) can distract patients from painful stimuli, enhance the quality of healthcare, and improve overall patient well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session). In addition to this internal control design, the study will also include an external control group consisting of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.
| Arm | Type | Receives |
|---|---|---|
| internal control design | Experimental | Device: VR sessionThe intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session during the same procedure). |
| external control group | Active comparator | Device: VR sessionThis arm consists of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- being ≥ 6 years old
- having a confirmed diagnosis of a hematological malignancy
- undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.
Key exclusion criteria (7 listed)
- unstable or photosensitive epilepsy
- hearing, visual, or inner ear impairments
- severe psychiatric, cognitive, or mental disorders
- Contagious diseases
- Communication difficulties
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 |
|---|---|---|
| VR sessionAlso: Standard careStandard care: Standard care. In both the external control group and the intervention group during Period 1, painful procedures will be performed ccording to usual clinical practice by trained healthcare professionals. VR session: The device includes a VR headset connected to a smartphone, which displays immersive visual content, along with headphones that deliver audio content. Scenarios are culturally and demographically adapted to the study population. The duration of each VR session will correspond to the time required for each painful procedure. | Device | external control group, internal control design |
Primary outcome
Change in pain levels using the Numeric Rating Scale (0-10)
Time frame: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
The Numeric rating scale (NRS) of pain is a scale from 0 to 10, where scores from 0 to 3 indicate mild pain, 4 to 6 indicate moderate pain, and 7 to 10 indicate severe pain. The NRS has been proven valid and reliable for measuring cancer-related pain. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care, VR session)
1 secondary outcome
Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2)
Time frame: Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 42885483Amara Y, Ben Mahmoud L, Ammar M, Zghal K, Hakim A, Elloumi M, Mdhaffar M, Frikha I. Evaluation of the impact of virtual reality as a non-pharmacological intervention for pain and anxiety during hematology procedures and chemotherapy: a controlled trial. Future Sci OA. 2026 Dec;12(1):2746758. doi: 10.1080/20565623.2026.2746758. Epub 2026 Oct 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR session in people with Pain Management and Anxiety, run by Yesmine Amara at 1 site in Tunisia.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yesmine Amara, PhD student (00 216 50 260 564, benmahmoud_lobna@medecinesfax.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain levels using the Numeric Rating Scale (0-10) (time frame: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085065, which also lists 1 linked publication.
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 25 Jul 2025.