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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headset-based Virtual Reality Simulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or nursing women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dubai Thalassemia Center | Dubai | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30109720 | Background | 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. | |
| 33321461 | Background | Gerceker 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. |
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Individual participant data (IPD) will not be shared. The study results will be published in aggregate form only.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 12, 2025 | |
| Reset | Aug 29, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2024 |
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|
| 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. | 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'. | 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 | 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 | 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. |
| 28667088 | Background | Pandis 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. |
| 31221208 | Background | Wong 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. |
| 31160472 | Background | Walther-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. |
| 16466904 | Background | Deacon 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. |
| 15155061 | Background | Neugebauer V, Li W, Bird GC, Han JS. The amygdala and persistent pain. Neuroscientist. 2004 Jun;10(3):221-34. doi: 10.1177/1073858403261077. |
| 24892196 | Background | Wiederhold 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. |
| 16640481 | Background | Gold 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. |
| 30256662 | Background | Mosso 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. |
| 33036555 | Background | Chan 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. |
| 31047650 | Background | Chan 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. |
| 19231295 | Background | Rutter 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. |
| 31501078 | Background | Aykanat 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. |
| 16093522 | Background | Kazak 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. |
| 18507891 | Background | Scalone L, Mantovani LG, Krol M, Rofail D, Ravera S, Bisconte MG, Borgna-Pignatti C, Borsellino Z, Cianciulli P, Gallisai D, Prossomariti L, Stefano I, Cappellini MD. Costs, quality of life, treatment satisfaction and compliance in patients with beta-thalassemia major undergoing iron chelation therapy: the ITHACA study. Curr Med Res Opin. 2008 Jul;24(7):1905-17. doi: 10.1185/03007990802160834. Epub 2008 May 27. |
| 20437613 | Background | Al-Gazali L, Ali BR. Mutations of a country: a mutation review of single gene disorders in the United Arab Emirates (UAE). Hum Mutat. 2010 May;31(5):505-20. doi: 10.1002/humu.21232. |
| 22074124 | Background | Baysal E. Molecular basis of beta-thalassemia in the United Arab Emirates. Hemoglobin. 2011;35(5-6):581-8. doi: 10.3109/03630269.2011.634706. |
| 11480786 | Background | Baysal E. Hemoglobinopathies in the United Arab Emirates. Hemoglobin. 2001 May;25(2):247-53. doi: 10.1081/hem-100104033. |
| Jul 5, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form: For Adults (>18yr) - English | May 15, 2023 | Jul 24, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent Form: For Children (<18yr) - English | May 15, 2023 | Jul 24, 2025 | ICF_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 12, 2025 | Aug 29, 2025 |
| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| D013789 | Thalassemia |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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