Anxiety, Blood Disorder, Pain, Thalassemia, Thalassemia, Beta
Conditions
Keywords
thalassemia, Beta thalassemia, Virtual Reality, UAE, Pain, Anxiety, Intravenous cannulation, virtual reality therapy, medical hypnosis, digital health
Brief 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 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.
Interventions
DEVICEHeadset-based Virtual Reality Simulation
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.
Sponsors
Mohammed Bin Rashid University of Medicine and Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain using the Visual Analogue Scale | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Patient Satisfaction | 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 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'. |
| Assessment of Fatigue using the Visual Analogue Scale | 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 fatigue and 10 indicates the worst possible fatigue. |
| Heart Rate (BPM) | 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. | Patient's vital signs were taken after the cannulation procedure |
| Blood Pressure (mmHg) | 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. | Patient's vital signs were taken after the cannulation procedure |
| Assessment of Boredom using the Visual Analogue Scale | 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 boredom and 10 indicates the worst possible boredom. |
Countries
United Arab Emirates
Outcome results
None listed