Pediatric PopulationNCT06044753
Comparing the Effectiveness of Virtual Reality in Paediatric Patients
A study testing Virtual Reality Headset in people with Pediatric Population and Preoperative Anxiety, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To the best of our knowledge,the investigators found only a study using VR in reducing preoperative anxiety in paediatric population. Ryu et al found that children who received preoperative VR tour of the operation theatre had perfect score in induction compliance checklist (ICC). Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Population, Preoperative Anxiety
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2020to 1 Dec 2021
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) I or II patients.
- Patients between 4-12 years of age.
- Elective and emergency cases
Who cannot join
- Maxillofacial anomalies
- Skull anomalies that make fitting mask difficult
- Visual and hearing impairment
- Epilepsy
- Contraindication to nitrous oxide and sevoflurane inhalation induction. For example; malignant hyperthermia, ear surgery and pneumothorax.
- Autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Virtual Reality Versus Control Group in Reducing Preoperative Anxiety in Pediatric Patients
To the best of our knowledge,the investigators found only a study using VR in reducing preoperative anxiety in paediatric population. Ryu et al found that children who received preoperative VR tour of the operation theatre had perfect score in induction compliance checklist (ICC).
With these encouraging data,the investigators decide to conduct a study to determine whether the use of cartoon video VR headset during induction of anaesthesia is able to reduce preoperative anxiety and increase compliance during inhalation induction in children undergoing surgery.
Read the detailed description
Patients will be reviewed prior to surgery, where explanation will be given and consent from patient's parents will be obtained. Once the parents consented for the study, patient will be recruited. Randomization will be carried out using a computer-generated system randomizing patient to two groups, Group 1 which is standard care/control group (as per usual practice) whereas Group 2 is VR intervention group. No premedication prescribed to patients.
Non immersive VR experience basically means providing a near reality environment for viewers, however, viewers won't be able to make any changes to it as they can only watch.
This Non-immersive Virtual reality experience will be applied unto the child by using a headset that incorporates a computerized dimensional environment which will be simulated to make the child feel near reality .The VR headset consist of a cover for handphone slot, screen display, two lenses with adjustable eye pieces to focus, foam padding and adjustable elastic head mount.
Group 2 patients will be tested for the suitability of mask size and applied together with the VR headset, meanwhile the strap for VR headset is adjusted accordingly to patient's head circumference and fixed for later use. The patient will choose one of the three YouTube videos, either Frozen theme song, SpongeBob or Minions according to their preference. These VR cartoon videos are 3-Dimension cartoon which are available to view for free. Frozen is a famous Disney cartoon, SpongeBob is an American animated cartoon series whereas Minions is an animated comedy film. The selected video will be played on the doctor's handphone and slotted into the VR headset. The codes for the VR cartoon videos will be scanned by the anaesthesiology trainees' registrars and specialists and downloaded into their handphone. The VR cartoon will be shown to the patients for 30 seconds to accustom them to wear the VR.
On the operation day, patients will enter the operation room as routine, while the primary investigator observes the patient and score their anxiety level using modified Yale Preoperative Anxiety Scale (mYPAS) upon arrival to operation room. Modified Yale Preoperative anxiety scale has been proved to be a reliable assessment tool. The mYPAS is a 22-itemized score divided into 5 categories which are activities, vocalization, expressing emotions, state of arousal and interaction with family members. Each category was scored from 1 to 4, except for vocalization, which scored from 1 to 6. As each category is itemized differently, partial weights were calculated and then added to the total score. The total score will be calculated post-intubation. The scoring will be done by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), the produced values will be summed. Divide by 4 and multiply by 100. mYPAS scores of ≤30 is described as non-anxious, and mYPAS score > 30 is described as anxious with the minimum score of 23.3 to maximum score of 100.13 Subsequently, the patients will be placed either on the operation table or be sited on the parent's lap depending on the patient's cooperation. The position of patients during induction is documented. Oxygen saturation probe will be applied on them. Baseline heart rate (HR) and SpO2 will be documented. Group 1 patients will receive standard care of inhaling gaseous induction through mask. For Group 2, a handphone playing YouTube videos (either Frozen or SpongeBob or Minions VR cartoons) will be slotted into the VR headset prior to applying on the patient. They will have mask on first followed by the VR headset. Patients in both groups will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner. Non-invasive blood pressure (NIBP) cuff and electrocardiogram (ECG) leads will be applied to the patients. BP, HR, SpO2 during induction and post-intubation will be recorded.
Following intubation, the attending anaesthetist will score the induction compliance checklist (ICC) which is an observational scale on the patient compliance to inhalational induction and mask acceptance. The ICC is a validated checklist and contains 10 negative behavioural groupings. The ICC score represents the sum of the groupings checked as present during induction; high scores correlate with poor behavioural compliance. A perfect induction (no negative behaviours) is scored as 0; the highest possible score is 10. For purposes of analysis, ICC scores were stratified into three categories: perfect (ICC = 0), moderate (1-3) and poor (≥4).
Anaesthetist in Group 2 will fill up a System Usability Scale (SUS). This scale was created by John Brooke in 1986 and used extensively to test numerous products and services. The SUS consists of 10 questions with 5 responses for each question ranging from "strongly agree" to "strongly disagree". The calculation of the usability score for SUS is, for each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. The produced values will be summed and multiply by 2.5. Questions 1,3,5,7 and 9 are positive whereas questions 2,4,6,8 and 10 are negative. The score is graded to five grades, score >80.3 (Grade A/ excellent), 68-80.3 (Grade B/ good), 68 (Grade C/ okay), 51-68 (Grade D/ poor) and ˂51 (Grade F/ awful).
In a situation where patient is unable to wear VR headset, the patient will be considered dropped off from the study. However, if the patient removes the VR headset or pushes away the mask during inhalation, data will still be recruited and considered, hence not a drop out case.
Collected data will be used to measure the association of mYPAS anxiety score with the ICC, which will determine the compliancy of patient to mask acceptance during induction. If the VR group shows a high mYPAS score yet a perfect or low ICC score compared to standard care group, hence the investigators can prove that VR does effectively decrease anxiety in paediatrics during inhalational induction.
- Conditions
- Pediatric Population, Preoperative Anxiety
- Being tested
- Virtual Reality Headset
- Keywords
- Induction of anaesthesia, Preoperative anxiety, Virtual reality, Paediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Non immersive VR experience basically means providing a near reality environment for viewers, however, viewers won't be able to make any changes to it as they can only watch.
This Non-immersive Virtual reality experience will be applied unto the child by using a headset that incorporates a computerized dimensional environment which will be simulated to make the child feel near reality .The VR headset consist of a cover for handphone slot, screen display, two lenses with adjustable eye pieces to focus, foam padding and adjustable elastic head mount strap.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm( Arm1) | No intervention | Arm1 which is standard care/control group (as per usual practice). May use the distraction, Parental presence, or with musics, soft prep talks, distractions with toys, as per anaesthetist's usual practice. Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner |
| VR ( Virtual Reality) ( Arm2) | Experimental | Group 2 patients will choose one of the three YouTube videos, either Frozen theme song, SpongeBob or Minions according to their preference. The selected video will be played on the doctor's handphone and slotted into the VR headset.A handphone playing YouTube videos (either Frozen or SpongeBob or Minions VR cartoons) will be slotted into the VR headset prior to applying on the patient. They will have mask on first followed by the VR headset.
Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Effectiveness of Virtual reality intervention versus standard care in reducing anxiety in paediatric patients undergoing inhalation induction
Primary objective is to compare effectiveness of virtual reality ( VR) intervention versus standard care in reducing anxiety of paediatric patients undergoing inhalation induction of anaesthesia by using the induction compliance checklist and compare with their mYPAS score. If the mYPAS score is high in Virtual Reality arm, however, Induction Compliance checklist is perfect score, hence we can conclude that VR arm patient have benefitted from the use of VR in reducing preoperative anxiety.
Measured: 1 year
Secondary outcomes (1)
Secondary objective is to investigate system usability of using virtual reality in inducing paediatric patients.
By using the system usability scale scoring by operators in virtual reality arm, we can determine whether the use of virtual reality headset is helpful in our daily clinical practice
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric PopulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paediatric Patients age 4 to 12 .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Budiman, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Maryam Budiman, Principal investigator, Universiti Kebansaan Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044753
- Sponsor's protocol ID
- JEP-2020-363
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
PubMed 28975600Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
PubMed 23051880Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
PubMed 10320165Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
PubMed 24257388Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
PubMed 20691523
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Virtual Reality Versus Control Group in Reducing Preoperative Anxiety in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06044753
- Acronym / sponsor ID
- JEP-2020-363
- Conditions
- Pediatric Population, Preoperative Anxiety
- Keywords
- Induction of anaesthesia, Preoperative anxiety, Virtual reality, Paediatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Sep 2023 (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.
To the best of our knowledge,the investigators found only a study using VR in reducing preoperative anxiety in paediatric population. Ryu et al found that children who received preoperative VR tour of the operation theatre had perfect score in induction compliance checklist (ICC).
With these encouraging data,the investigators decide to conduct a study to determine whether the use of cartoon video VR headset during induction of anaesthesia is able to reduce preoperative anxiety and increase compliance during inhalation induction in children undergoing surgery.
Detailed description
Patients will be reviewed prior to surgery, where explanation will be given and consent from patient's parents will be obtained. Once the parents consented for the study, patient will be recruited. Randomization will be carried out using a computer-generated system randomizing patient to two groups, Group 1 which is standard care/control group (as per usual practice) whereas Group 2 is VR intervention group. No premedication prescribed to patients.
Non immersive VR experience basically means providing a near reality environment for viewers, however, viewers won't be able to make any changes to it as they can only watch.
This Non-immersive Virtual reality experience will be applied unto the child by using a headset that incorporates a computerized dimensional environment which will be simulated to make the child feel near reality .The VR headset consist of a cover for handphone slot, screen display, two lenses with adjustable eye pieces to focus, foam padding and adjustable elastic head mount.
Group 2 patients will be tested for the suitability of mask size and applied together with the VR headset, meanwhile the strap for VR headset is adjusted accordingly to patient's head circumference and fixed for later use. The patient will choose one of the three YouTube videos, either Frozen theme song, SpongeBob or Minions according to their preference. These VR cartoon videos are 3-Dimension cartoon which are available to view for free. Frozen is a famous Disney cartoon, SpongeBob is an American animated cartoon series whereas Minions is an animated comedy film. The selected video will be played on the doctor's handphone and slotted into the VR headset. The codes for the VR cartoon videos will be scanned by the anaesthesiology trainees' registrars and specialists and downloaded into their handphone. The VR cartoon will be shown to the patients for 30 seconds to accustom them to wear the VR.
On the operation day, patients will enter the operation room as routine, while the primary investigator observes the patient and score their anxiety level using modified Yale Preoperative Anxiety Scale (mYPAS) upon arrival to operation room. Modified Yale Preoperative anxiety scale has been proved to be a reliable assessment tool. The mYPAS is a 22-itemized score divided into 5 categories which are activities, vocalization, expressing emotions, state of arousal and interaction with family members. Each category was scored from 1 to 4, except for vocalization, which scored from 1 to 6. As each category is itemized differently, partial weights were calculated and then added to the total score. The total score will be calculated post-intubation. The scoring will be done by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), the produced values will be summed. Divide by 4 and multiply by 100. mYPAS scores of ≤30 is described as non-anxious, and mYPAS score > 30 is described as anxious with the minimum score of 23.3 to maximum score of 100.13 Subsequently, the patients will be placed either on the operation table or be sited on the parent's lap depending on the patient's cooperation. The position of patients during induction is documented. Oxygen saturation probe will be applied on them. Baseline heart rate (HR) and SpO2 will be documented. Group 1 patients will receive standard care of inhaling gaseous induction through mask. For Group 2, a handphone playing YouTube videos (either Frozen or SpongeBob or Minions VR cartoons) will be slotted into the VR headset prior to applying on the patient. They will have mask on first followed by the VR headset. Patients in both groups will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner. Non-invasive blood pressure (NIBP) cuff and electrocardiogram (ECG) leads will be applied to the patients. BP, HR, SpO2 during induction and post-intubation will be recorded.
Following intubation, the attending anaesthetist will score the induction compliance checklist (ICC) which is an observational scale on the patient compliance to inhalational induction and mask acceptance. The ICC is a validated checklist and contains 10 negative behavioural groupings. The ICC score represents the sum of the groupings checked as present during induction; high scores correlate with poor behavioural compliance. A perfect induction (no negative behaviours) is scored as 0; the highest possible score is 10. For purposes of analysis, ICC scores were stratified into three categories: perfect (ICC = 0), moderate (1-3) and poor (≥4).
Anaesthetist in Group 2 will fill up a System Usability Scale (SUS). This scale was created by John Brooke in 1986 and used extensively to test numerous products and services. The SUS consists of 10 questions with 5 responses for each question ranging from "strongly agree" to "strongly disagree". The calculation of the usability score for SUS is, for each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. The produced values will be summed and multiply by 2.5. Questions 1,3,5,7 and 9 are positive whereas questions 2,4,6,8 and 10 are negative. The score is graded to five grades, score >80.3 (Grade A/ excellent), 68-80.3 (Grade B/ good), 68 (Grade C/ okay), 51-68 (Grade D/ poor) and ˂51 (Grade F/ awful).
In a situation where patient is unable to wear VR headset, the patient will be considered dropped off from the study. However, if the patient removes the VR headset or pushes away the mask during inhalation, data will still be recruited and considered, hence not a drop out case.
Collected data will be used to measure the association of mYPAS anxiety score with the ICC, which will determine the compliancy of patient to mask acceptance during induction. If the VR group shows a high mYPAS score yet a perfect or low ICC score compared to standard care group, hence the investigators can prove that VR does effectively decrease anxiety in paediatrics during inhalational induction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Paediatric Patients age 4 to 12 .
| Arm | Type | Receives |
|---|---|---|
| Control Arm( Arm1) | No intervention | –Arm1 which is standard care/control group (as per usual practice). May use the distraction, Parental presence, or with musics, soft prep talks, distractions with toys, as per anaesthetist's usual practice. Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner |
| VR ( Virtual Reality) ( Arm2) | Experimental | Device: Virtual Reality HeadsetGroup 2 patients will choose one of the three YouTube videos, either Frozen theme song, SpongeBob or Minions according to their preference. The selected video will be played on the doctor's handphone and slotted into the VR headset.A handphone playing YouTube videos (either Frozen or SpongeBob or Minions VR cartoons) will be slotted into the VR headset prior to applying on the patient. They will have mask on first followed by the VR headset. Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) I or II patients.
- Patients between 4-12 years of age.
- Elective and emergency cases
Key exclusion criteria (6 listed)
- Maxillofacial anomalies
- Skull anomalies that make fitting mask difficult
- Visual and hearing impairment
- Epilepsy
- Contraindication to nitrous oxide and sevoflurane inhalation induction. For example; malignant hyperthermia, ear surgery and pneumothorax.
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 |
|---|---|---|
| Virtual Reality HeadsetNon immersive VR experience basically means providing a near reality environment for viewers, however, viewers won't be able to make any changes to it as they can only watch. This Non-immersive Virtual reality experience will be applied unto the child by using a headset that incorporates a computerized dimensional environment which will be simulated to make the child feel near reality .The VR headset consist of a cover for handphone slot, screen display, two lenses with adjustable eye pieces to focus, foam padding and adjustable elastic head mount strap. | Device | VR ( Virtual Reality) ( Arm2) |
Primary outcome
Compare Effectiveness of Virtual reality intervention versus standard care in reducing anxiety in paediatric patients undergoing inhalation induction
Time frame: 1 year
Primary objective is to compare effectiveness of virtual reality ( VR) intervention versus standard care in reducing anxiety of paediatric patients undergoing inhalation induction of anaesthesia by using the induction compliance checklist and compare with their mYPAS score. If the mYPAS score is high in Virtual Reality arm, however, Induction Compliance checklist is perfect score, hence we can conclude that VR arm patient have benefitted from the use of VR in reducing preoperative anxiety.
1 secondary outcome
Secondary objective is to investigate system usability of using virtual reality in inducing paediatric patients.
Time frame: 1 year
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 21 Sep 2023.
- Background: PubMed 28975600Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
- Background: PubMed 23051880Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
- Background: PubMed 10320165Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
- Background: PubMed 24257388Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
- Background: PubMed 20691523Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
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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.
Maryam Budiman principal investigator
Universiti Kebansaan Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with Pediatric Population and Preoperative Anxiety, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 6 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 21 Sep 2023. 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 Malaysia. 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?
Compare Effectiveness of Virtual reality intervention versus standard care in reducing anxiety in paediatric patients undergoing inhalation induction (time frame: 1 year). 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 NCT06044753, which also lists 5 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 21 Sep 2023.