Thalassemia, BetaNCT07099196
Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in UAE.
A study testing Headset-based Virtual Reality Simulation in people with Thalassemia, Beta and Thalassemia, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
Trial summary
The goal of this trial is to evaluate the effects of therapeutic Virtual Reality (VR) on pain, anxiety, fatigue and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).The main question it aims to answer is whether VR can act as an adjuvant for the IV cannulation procedure and improve… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Thalassemia, Beta, Thalassemia, Pain
- What is being tested?
- Headset-based Virtual Reality Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 24 May 2024to 20 Aug 2024
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a diagnosis of thalassemia
- Thalassemia patients undergoing intravenous cannulation procedure
- Patients aged >7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center
Who cannot join
- Pregnant or nursing women
- Patients of legal age but subject to legal protection measures or unable to express their consent
- Patients suffering from uncontrolled epilepsy
- Patients with visual or auditory disorders
- Patients suffering from claustrophobia or motion sickness
- Patients with face infections
- Patients with dissociative psychiatric pathologies and/or autism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Potential of Virtual Reality in Alleviating Pain and Anxiety Among Thalassemia Patients During Intravenous Cannulation: A Crossover Clinical Trial
The goal of this trial is to evaluate the effects of therapeutic Virtual Reality (VR) on pain, anxiety, fatigue and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).The main question it aims to answer is whether VR can act as an adjuvant for the IV cannulation procedure and improve overall patient experience.
Questionnaires were completed after the intravenous cannulation procedure during visits 1, 2 and 3. The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives, collecting self-reported data during the three visits.
Read more
Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)) were measured after each procedure
- Participants will come for their routine cannulation and be recruited if willing
- Participants carry out the SOC procedure and are asked to fill out the questionnaires after
- The procedure is carried out with VR at the next appointment after 3-4 weeks
- This is repeated in the next visit
Read the detailed description
Patients were screened at the Dubai Thalassemia Center during routine consultations, where the investigator present explained the study's objectives to the patient.
After consulting the patients' medical records and ensuring that there were no exclusion criteria and that the inclusion criteria were met, the investigators introduced themselves to the patients and their families, offering them the chance to take part in the study.
The investigators then explained to patients that they were eligible for this study and described the study's aims. Written, signed consent was obtained from adult patients and guardians of minors with an informed consent form.
Additionally, patients aged <18 years were provided with an assent form with simplified information about the study. Investigators took the time to answer the patient's questions about the study's progress, expected results, and anticipated benefits.
No financial compensation was paid to participants in this study. Participation in this study had no financial consequences for the participant, nor on his/her health insurance, as this was part of the routine care and consultation for the patient.
Participants were free to withdraw from the study at any time during the procedure. In the event of withdrawal, the data collected up to that point was analyzed, so as not to compromise the value of the study. Regardless of withdrawal, the anonymity of all patient data was maintained.
Interventions Patients benefited from the standard of care during their first visit, then utilized the VR intervention during the cannulation in their second visit and finally, another VR session in the third.
We used therapeutic immersions curated by the France-based company Healthy Mind, with various environments, including elements of medical hypnosis and breathing exercises, tailored for use in invasive procedures.
For each patient, the overall duration of the study was 6-8 weeks to complete all three visits, considering the 3-4 week interval between their scheduled appointments at the thalassemia center.
It should be noted that appointments were postponed if the patient did not complete the routine cross-matching test prior to the intravenous cannulation procedure or did not show up for their appointments.
- Conditions
- Thalassemia, Beta, Thalassemia, Pain, Anxiety, Blood Disorder
- Being tested
- Headset-based Virtual Reality Simulation
- Keywords
- thalassemia, Beta thalassemia, Virtual Reality, UAE, Pain, Anxiety, Intravenous cannulation, virtual reality therapy, medical hypnosis, digital health
- Medical subject headings
- beta-Thalassemia, Thalassemia, Pain, Anxiety Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headset-based Virtual Reality SimulationDevice
Also called Medical Hypnosis, Relaxation Tool, virtual reality, therapeutic virtual reality
The device used was a HEALTHY-MIND© PICO G2 Virtual Reality headset, which is medically graded and suited for distraction and relaxation in clinical settings.
| Study group | Role | What they receive |
|---|---|---|
| Thalassemia patients | Experimental | This arm acts as its own control, with participants receiving SOC for their first visit, and then receiving VR for their next 2 visits during their cannulation procedure. Receives: Device: Headset-based Virtual Reality Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain using the Visual Analogue Scale
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no pain and 10 indicates the worst possible pain.
Measured: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Assessment of Anxiety using the Visual Analogue Scale
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, Zero is equivalent to no anxiety and 10 indicates the worst possible anxiety.
Measured: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Secondary outcomes (5)
Assessment of Fatigue using the Visual Analogue Scale
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no fatigue and 10 indicates the worst possible fatigue.
Measured: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Assessment of Boredom using the Visual Analogue Scale
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no boredom and 10 indicates the worst possible boredom.
Measured: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Assessment of Patient Satisfaction
Self-reported data using a questionnaire assessing their overall satisfaction, asking specific questions using the virtual reality headset during their second visit. (breathing exercises, chosen environment, feeling of relaxation etc..). Scale ranges from 'Very Dissatisfied' - 'Dissatisfied' - 'Neutral' - 'Satisfied' - 'Very Satisfied' - 'I don't know'.
Measured: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Blood Pressure (mmHg)
Patient's vital signs were taken after the cannulation procedure
Measured: After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Heart Rate (BPM)
Patient's vital signs were taken after the cannulation procedure
Measured: After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start24 May 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Thalassemia, BetaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameer Asim Khan, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099196
- Sponsor's protocol ID
- MBRU-IRB-2024-80
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study results will be published in aggregate form only.
Publications
McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
PubMed 30109720Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
PubMed 33321461Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017 Jun 30;357:j2835. doi: 10.1136/bmj.j2835.
PubMed 28667088Wong CL, Lui MMW, Choi KC. Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial. Trials. 2019 Jun 20;20(1):369. doi: 10.1186/s13063-019-3443-z.
PubMed 31221208Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.
PubMed 31160472Deacon B, Abramowitz J. Anxiety sensitivity and its dimensions across the anxiety disorders. J Anxiety Disord. 2006;20(7):837-57. doi: 10.1016/j.janxdis.2006.01.003. Epub 2006 Feb 8.
PubMed 16466904Neugebauer V, Li W, Bird GC, Han JS. The amygdala and persistent pain. Neuroscientist. 2004 Jun;10(3):221-34. doi: 10.1177/1073858403261077.
PubMed 15155061Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.
PubMed 24892196Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
PubMed 16640481Mosso Vazquez JL, Mosso Lara D, Mosso Lara JL, Miller I, Wiederhold MD, Wiederhold BK. Pain Distraction During Ambulatory Surgery: Virtual Reality and Mobile Devices. Cyberpsychol Behav Soc Netw. 2019 Jan;22(1):15-21. doi: 10.1089/cyber.2017.0714. Epub 2018 Sep 25.
PubMed 30256662Chan JJI, Yeam CT, Kee HM, Tan CW, Sultana R, Sia ATH, Sng BL. The use of pre-operative virtual reality to reduce anxiety in women undergoing gynecological surgeries: a prospective cohort study. BMC Anesthesiol. 2020 Oct 9;20(1):261. doi: 10.1186/s12871-020-01177-6.
PubMed 33036555Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
PubMed 31047650Rutter CE, Dahlquist LM, Weiss KE. Sustained efficacy of virtual reality distraction. J Pain. 2009 Apr;10(4):391-7. doi: 10.1016/j.jpain.2008.09.016. Epub 2009 Feb 23.
PubMed 19231295Aykanat Girgin B, Gol I. Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study. Pain Manag Nurs. 2020 Jun;21(3):276-282. doi: 10.1016/j.pmn.2019.07.006. Epub 2019 Sep 26.
PubMed 31501078Kazak AE, Kassam-Adams N, Schneider S, Zelikovsky N, Alderfer MA, Rourke M. An integrative model of pediatric medical traumatic stress. J Pediatr Psychol. 2006 May;31(4):343-55. doi: 10.1093/jpepsy/jsj054. Epub 2005 Aug 10.
PubMed 16093522
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Potential of Virtual Reality in Alleviating Pain and Anxiety Among Thalassemia Patients During Intravenous Cannulation: A Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07099196
- Acronym / sponsor ID
- MBRU-IRB-2024-80
- Conditions
- Thalassemia, Beta, Thalassemia, Pain, Anxiety, Blood Disorder
- Keywords
- thalassemia, Beta thalassemia, Virtual Reality, UAE, Pain, Anxiety, Intravenous cannulation, virtual reality therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 1 Aug 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 trial is to evaluate the effects of therapeutic Virtual Reality (VR) on pain, anxiety, fatigue and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).The main question it aims to answer is whether VR can act as an adjuvant for the IV cannulation procedure and improve overall patient experience.
Questionnaires were completed after the intravenous cannulation procedure during visits 1, 2 and 3. The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives, collecting self-reported data during the three visits.
Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)) were measured after each procedure
- Participants will come for their routine cannulation and be recruited if willing
- Participants carry out the SOC procedure and are asked to fill out the questionnaires after
- The procedure is carried out with VR at the next appointment after 3-4 weeks
- This is repeated in the next visit
Detailed description
Patients were screened at the Dubai Thalassemia Center during routine consultations, where the investigator present explained the study's objectives to the patient.
After consulting the patients' medical records and ensuring that there were no exclusion criteria and that the inclusion criteria were met, the investigators introduced themselves to the patients and their families, offering them the chance to take part in the study.
The investigators then explained to patients that they were eligible for this study and described the study's aims. Written, signed consent was obtained from adult patients and guardians of minors with an informed consent form.
Additionally, patients aged <18 years were provided with an assent form with simplified information about the study. Investigators took the time to answer the patient's questions about the study's progress, expected results, and anticipated benefits.
No financial compensation was paid to participants in this study. Participation in this study had no financial consequences for the participant, nor on his/her health insurance, as this was part of the routine care and consultation for the patient.
Participants were free to withdraw from the study at any time during the procedure. In the event of withdrawal, the data collected up to that point was analyzed, so as not to compromise the value of the study. Regardless of withdrawal, the anonymity of all patient data was maintained.
Interventions Patients benefited from the standard of care during their first visit, then utilized the VR intervention during the cannulation in their second visit and finally, another VR session in the third.
We used therapeutic immersions curated by the France-based company Healthy Mind, with various environments, including elements of medical hypnosis and breathing exercises, tailored for use in invasive procedures.
For each patient, the overall duration of the study was 6-8 weeks to complete all three visits, considering the 3-4 week interval between their scheduled appointments at the thalassemia center.
It should be noted that appointments were postponed if the patient did not complete the routine cross-matching test prior to the intravenous cannulation procedure or did not show up for their appointments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalassemia patients | Experimental | Device: Headset-based Virtual Reality SimulationThis arm acts as its own control, with participants receiving SOC for their first visit, and then receiving VR for their next 2 visits during their cannulation procedure. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of thalassemia
- Thalassemia patients undergoing intravenous cannulation procedure
- Patients aged >7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center
Key exclusion criteria (7 listed)
- Pregnant or nursing women
- Patients of legal age but subject to legal protection measures or unable to express their consent
- Patients suffering from uncontrolled epilepsy
- Patients with visual or auditory disorders
- Patients suffering from claustrophobia or motion sickness
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 |
|---|---|---|
| Headset-based Virtual Reality SimulationAlso: Medical Hypnosis, Relaxation Tool, virtual reality, therapeutic virtual realityThe device used was a HEALTHY-MIND© PICO G2 Virtual Reality headset, which is medically graded and suited for distraction and relaxation in clinical settings. | Device | Thalassemia patients |
Primary outcome
Assessment of Pain using the Visual Analogue Scale
Time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no pain and 10 indicates the worst possible pain.
Assessment of Anxiety using the Visual Analogue Scale
Time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, Zero is equivalent to no anxiety and 10 indicates the worst possible anxiety.
5 secondary outcomes
Assessment of Fatigue using the Visual Analogue Scale
Time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Assessment of Boredom using the Visual Analogue Scale
Time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Assessment of Patient Satisfaction
Time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Blood Pressure (mmHg)
Time frame: After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Heart Rate (BPM)
Time frame: After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
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 1 Aug 2025.
- Background: PubMed 30109720McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
- Background: PubMed 33321461Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
- Background: PubMed 28667088Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017 Jun 30;357:j2835. doi: 10.1136/bmj.j2835.
- Background: PubMed 31221208Wong CL, Lui MMW, Choi KC. Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial. Trials. 2019 Jun 20;20(1):369. doi: 10.1186/s13063-019-3443-z.
- Background: PubMed 31160472Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.
- Background: PubMed 16466904Deacon B, Abramowitz J. Anxiety sensitivity and its dimensions across the anxiety disorders. J Anxiety Disord. 2006;20(7):837-57. doi: 10.1016/j.janxdis.2006.01.003. Epub 2006 Feb 8.
- Background: PubMed 15155061Neugebauer V, Li W, Bird GC, Han JS. The amygdala and persistent pain. Neuroscientist. 2004 Jun;10(3):221-34. doi: 10.1177/1073858403261077.
- Background: PubMed 24892196Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.
- Background: PubMed 16640481Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
- Background: PubMed 30256662Mosso Vazquez JL, Mosso Lara D, Mosso Lara JL, Miller I, Wiederhold MD, Wiederhold BK. Pain Distraction During Ambulatory Surgery: Virtual Reality and Mobile Devices. Cyberpsychol Behav Soc Netw. 2019 Jan;22(1):15-21. doi: 10.1089/cyber.2017.0714. Epub 2018 Sep 25.
- Background: PubMed 33036555Chan JJI, Yeam CT, Kee HM, Tan CW, Sultana R, Sia ATH, Sng BL. The use of pre-operative virtual reality to reduce anxiety in women undergoing gynecological surgeries: a prospective cohort study. BMC Anesthesiol. 2020 Oct 9;20(1):261. doi: 10.1186/s12871-020-01177-6.
- Background: PubMed 31047650Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study results will be published in aggregate form only.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headset-based Virtual Reality Simulation in people with Thalassemia, Beta and Thalassemia, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
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: finished, as of the sponsor's last update on 1 Aug 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 United Arab Emirates. 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?
Assessment of Pain using the Visual Analogue Scale (time frame: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.). The study lists 2 primary outcomes in all. 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 NCT07099196, which also lists 19 linked publications.
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 1 Aug 2025.