TonsillectomyNCT03239743
Effects of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in Children and Adolescents
A study testing Virtual Reality and Midazolam in people with Tonsillectomy, run by Valley Anesthesiology Consultants at 1 site in United States.
Trial summary
Pain and anxiety have a direct correlation. Patients who experience anxiety are more susceptible to feeling pain, and patients who experience pain are more likely to have a component of anxiety associated with their pain. A common technique used by pain psychologists to help minimize pain is distraction. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Virtual Reality and Midazolam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to May 2019
- 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any patient undergoing tonsillectomy or tonsillectomy and adenoidectomy procedure
- Must be between the ages of 5 and 11 years
- Anxious/moderate anxiety patients (mYPAS greater than or equal to 30)
Who cannot join
- Any patient with preoperative peripherally placed IV
- Any patient who is cognitively impaired
- Any patient with a previous surgery
- ASA Physical Status higher than II
- Body Mass Index >30
- A history of affective disorder, attention disorder, or psychotropic medication use
- Calm/low anxiety patients (mYPAS less than 30)
- Deaf or blind
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Raj Singhal, M.D., 602-933-4482, rsinghal@valley.md
Vanessa Pohl, B.S., 6029334482, vpohl@phoenixchildrens.com
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital
Pain and anxiety have a direct correlation. Patients who experience anxiety are more susceptible to feeling pain, and patients who experience pain are more likely to have a component of anxiety associated with their pain. A common technique used by pain psychologists to help minimize pain is distraction. Different forms of distraction include video games, movies, music, etc. Recently, doctors and researchers around the world have begun experimenting with Virtual Reality as a distraction technique.
A review of the use of virtual reality compared to the current standard of care may help uncover important trends regarding anxiety, postoperative pain and analgesic use in patients who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.
Read the detailed description
There are approximately five million pediatric surgeries performed in the United States every year, and approximately 50% of pediatric patients experience significant stress and anxiety before their surgery. High anxiety can result in increased postoperative pain, increased analgesic consumption, and delayed recovery. The perception of pain can have a strong psychological component and can increase if the patient gives the area of injury constant attention. Thus, different distraction techniques have been utilized by pain psychologists to take the patient's attention away from the area of injury.
Pharmacological intervention to treat preoperative anxiety in children has its own side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to alleviate preoperative anxiety. However, there are many side-effects that are not always preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been documented, and delayed emergence is possible in surgeries of short duration. In addition, midazolam can also result in critical events perioperatively, such as airway obstruction and worsened nausea and vomiting. Non-pharmacological interventions could help avoid these complications, however, current studies do not show a viable alternative to a pharmacological interventions.
Virtual Reality (VR) is a technology that allows individuals to experience a virtual world. VR initially began as a form of entertainment, but it has expanded its application into several other areas. Within the past 10 years, this type of technology has been applied clinically as a method of distraction for medical procedures such as chemotherapy, physical therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an interactive world stimulating sights, sounds, and motion to help enhance the distraction from pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual Reality Medical Center to test the usability and safety in patients with chronic pain. Patients were presented with pleasant relaxing scenes including natural areas like forests, beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing. Researchers in this study found that the pain distraction virtual environment (VE) was easy to use, had good stereo sound effects, and was immersive and interactive. They also found that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using the VR device. No studies have involved VR in setting of anesthesia induction period and a non-pharmacological intervention for preoperative anxiety.
A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a head-mounted VR device. All six study participants reported a significant drop in pain while using the natural VE. Similarly, a study from the University of Washington found that children playing VR video games or navigating through a virtual environment while receiving wound care for their burns had lower pain scores than patients who just played video games. Another study conducted by Wiederhold et al., looked at fear and pain before and after dental treatment and found a significant decrease in pain perception and stated anxiety scores in patients using the VR eyeglasses compared to the nonuse group.
Based on success in other medical procedures, we propose a study to examine the efficacy and feasibility of using VR during induction of anesthesia to help minimize anxiety, postoperative pain and analgesic use in patients undergoing a tonsillectomy or a tonsillectomy and adenoidectomy procedure.
- Conditions
- Tonsillectomy
- Being tested
- Virtual Reality, Midazolam
- Keywords
- virtual reality, adenoidectomy, induction of anesthesia, pre-operative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called KindVR
Child will wear and interact with virtual reality headset while waiting for surgery.
MidazolamDrug
Also called Versed
Child will receive Midazolam to help with pre-operative anxiety prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication. Receives: Device: Virtual Reality |
| Midazolam Group | Active comparator | Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Operative Anxiety measured by mYPAS anxiety scores
Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period
Measured: Baseline
Secondary outcomes (4)
Induction Compliance of Anesthesia measured by the induction compliance checklist
Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist.
Measured: Baseline
Post-Operative Emergence Delirium measured by the PAED scale
Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale.
Measured: up to 3 hours post operative
Post-Operative Pain
Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care.
Measured: up to 3 hours post operative
Post-Operative Opioid Use
Measure VR use will reduce opioid use compared to patients receiving standard of care
Measured: up to 3 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start20 Jul 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valley Anesthesiology Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- KindVR, Phoenix Children's Hospital
- Responsible party
- Principal investigator, Neil Raj Singhal, Valley Anesthesiology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239743
- Sponsor's protocol ID
- 17-025
- Status last verified
- Oct 2018
- First submitted
- 21 Apr 2017
- Last updated
- 19 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275Wiederhold 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 24892196Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PubMed 8953995Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
PubMed 24892198Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.
PubMed 24892200Wiederhold BK, Soomro A, Riva G, Wiederhold MD. Future directions: advances and implications of virtual environments designed for pain management. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):414-22. doi: 10.1089/cyber.2014.0197.
PubMed 24892206Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
PubMed 21264690
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital
- ClinicalTrials.gov ID
- NCT03239743
- Acronym / sponsor ID
- 17-025
- Conditions
- Tonsillectomy
- Keywords
- virtual reality, adenoidectomy, induction of anesthesia, pre-operative anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Valley Anesthesiology ConsultantsUniversity, hospital or other
- Collaborators
- KindVR, Phoenix Children's Hospital
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 4 Aug 2017 (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.
Pain and anxiety have a direct correlation. Patients who experience anxiety are more susceptible to feeling pain, and patients who experience pain are more likely to have a component of anxiety associated with their pain. A common technique used by pain psychologists to help minimize pain is distraction. Different forms of distraction include video games, movies, music, etc. Recently, doctors and researchers around the world have begun experimenting with Virtual Reality as a distraction technique.
A review of the use of virtual reality compared to the current standard of care may help uncover important trends regarding anxiety, postoperative pain and analgesic use in patients who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.
Detailed description
There are approximately five million pediatric surgeries performed in the United States every year, and approximately 50% of pediatric patients experience significant stress and anxiety before their surgery. High anxiety can result in increased postoperative pain, increased analgesic consumption, and delayed recovery. The perception of pain can have a strong psychological component and can increase if the patient gives the area of injury constant attention. Thus, different distraction techniques have been utilized by pain psychologists to take the patient's attention away from the area of injury.
Pharmacological intervention to treat preoperative anxiety in children has its own side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to alleviate preoperative anxiety. However, there are many side-effects that are not always preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been documented, and delayed emergence is possible in surgeries of short duration. In addition, midazolam can also result in critical events perioperatively, such as airway obstruction and worsened nausea and vomiting. Non-pharmacological interventions could help avoid these complications, however, current studies do not show a viable alternative to a pharmacological interventions.
Virtual Reality (VR) is a technology that allows individuals to experience a virtual world. VR initially began as a form of entertainment, but it has expanded its application into several other areas. Within the past 10 years, this type of technology has been applied clinically as a method of distraction for medical procedures such as chemotherapy, physical therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an interactive world stimulating sights, sounds, and motion to help enhance the distraction from pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual Reality Medical Center to test the usability and safety in patients with chronic pain. Patients were presented with pleasant relaxing scenes including natural areas like forests, beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing. Researchers in this study found that the pain distraction virtual environment (VE) was easy to use, had good stereo sound effects, and was immersive and interactive. They also found that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using the VR device. No studies have involved VR in setting of anesthesia induction period and a non-pharmacological intervention for preoperative anxiety.
A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a head-mounted VR device. All six study participants reported a significant drop in pain while using the natural VE. Similarly, a study from the University of Washington found that children playing VR video games or navigating through a virtual environment while receiving wound care for their burns had lower pain scores than patients who just played video games. Another study conducted by Wiederhold et al., looked at fear and pain before and after dental treatment and found a significant decrease in pain perception and stated anxiety scores in patients using the VR eyeglasses compared to the nonuse group.
Based on success in other medical procedures, we propose a study to examine the efficacy and feasibility of using VR during induction of anesthesia to help minimize anxiety, postoperative pain and analgesic use in patients undergoing a tonsillectomy or a tonsillectomy and adenoidectomy procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual RealitySubjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication. |
| Midazolam Group | Active comparator | Drug: MidazolamSubjects will be given the drug Midazolam to help alleviate the pre-operative anxiety. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any patient undergoing tonsillectomy or tonsillectomy and adenoidectomy procedure
- Must be between the ages of 5 and 11 years
- Anxious/moderate anxiety patients (mYPAS greater than or equal to 30)
Key exclusion criteria (8 listed)
- Any patient with preoperative peripherally placed IV
- Any patient who is cognitively impaired
- Any patient with a previous surgery
- ASA Physical Status higher than II
- Body Mass Index >30
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 RealityAlso: KindVRChild will wear and interact with virtual reality headset while waiting for surgery. | Device | Virtual Reality Group |
| MidazolamAlso: VersedChild will receive Midazolam to help with pre-operative anxiety prior to surgery | Drug | Midazolam Group |
Primary outcome
Pre-Operative Anxiety measured by mYPAS anxiety scores
Time frame: Baseline
Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period
4 secondary outcomes
Induction Compliance of Anesthesia measured by the induction compliance checklist
Time frame: Baseline
Post-Operative Emergence Delirium measured by the PAED scale
Time frame: up to 3 hours post operative
Post-Operative Pain
Time frame: up to 3 hours post operative
Post-Operative Opioid Use
Time frame: up to 3 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- 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 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Background: PubMed 8953995Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
- Background: PubMed 24892198Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
- Background: PubMed 24892200Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.
- Background: PubMed 24892206Wiederhold BK, Soomro A, Riva G, Wiederhold MD. Future directions: advances and implications of virtual environments designed for pain management. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):414-22. doi: 10.1089/cyber.2014.0197.
- Background: PubMed 21264690Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
- 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. This study is not recruiting at the moment.
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 and Midazolam in people with Tonsillectomy, run by Valley Anesthesiology Consultants at 1 site in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2018. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Pohl, B.S. (602-933-4482, vpohl@phoenixchildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Operative Anxiety measured by mYPAS anxiety scores (time frame: Baseline). 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 NCT03239743, which also lists 8 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 19 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.