Appendix RuptureNCT04357132
Virtual Reality for Appendectomy Pain
A study testing VR-Biofeedback and VR-Distraction in people with Appendix Rupture and Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Appendix Rupture, Pain, Pain, Postoperative
- What is being tested?
- VR-Biofeedback and VR-Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2020to 30 Aug 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8 - 18 years
- Able to read, understand, and speak English
- Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix
Who cannot join
- Outside of age range (<8 or >18 years)
- History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- History of vertigo, dizziness, and/or seizure disorders
- Conditions that would preclude the application of the VR headset, such as craniofacial deformities
- History of chronic pain, frequent opioid use and/or active cancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy
To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.
- Conditions
- Appendix Rupture, Pain, Pain, Postoperative
- Being tested
- VR-Biofeedback, VR-Distraction
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-BiofeedbackOther
Participants will be instructed to use the Mindful Aurora Application
VR-DistractionOther
Participants will be instructed to use one of four applications
| Study group | Role | What they receive |
|---|---|---|
| VR-Biofeedback | Other | Not described Receives: Other: VR-Biofeedback |
| VR-Distraction | Other | Not described Receives: Other: VR-Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: Before 10 minute VR session.
Effect on VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: Immediately after VR session.
Effect on VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: 15 minutes after VR session.
Effect on VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: 30 minutes after VR session.
Effect of VR-biofeedback on pain
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Measured: Postoperatively 24 - 90 hours.
Effect of VR-biofeedback on medication use
Amount of pain medications used will be collected
Measured: 24-90 hours
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: Before 10 minute VR session.
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: Immediately after 10 minute VR session.
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: 15 minutes after 10 minute VR session.
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: 30 minutes after 10 minute VR session.
Effect of VR-distraction on pain
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Measured: Postoperatively 24 - 90 hours.
Effect of VR-distraction on medication use
Pain medications used will be collected
Measured: 24-90 hours
Secondary outcomes (2)
Role of anxiety on changes in pain
Participants will complete a questionnaire regarding anxiety
Measured: One time prior to study visit
Role of pain catastrophizing
Participants will complete a questionnaire regarding pain
Measured: One time prior to study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start12 Jul 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendix RuptureStudies 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
- 60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Olbrecht, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357132
- Sponsor's protocol ID
- 2020-0258
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy
- ClinicalTrials.gov ID
- NCT04357132
- Acronym / sponsor ID
- 2020-0258
- Conditions
- Appendix Rupture, Pain, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Apr 2020 (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 determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
| Arm | Type | Receives |
|---|---|---|
| VR-Biofeedback | Other | Other: VR-Biofeedback |
| VR-Distraction | Other | Other: VR-Distraction |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 8 - 18 years
- Able to read, understand, and speak English
- Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix
Key exclusion criteria (5 listed)
- Outside of age range (<8 or >18 years)
- History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- History of vertigo, dizziness, and/or seizure disorders
- Conditions that would preclude the application of the VR headset, such as craniofacial deformities
- History of chronic pain, frequent opioid use and/or active cancer therapy
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 |
|---|---|---|
| VR-BiofeedbackParticipants will be instructed to use the Mindful Aurora Application | Other | VR-Biofeedback |
| VR-DistractionParticipants will be instructed to use one of four applications | Other | VR-Distraction |
Primary outcome
Effect on VR-biofeedback on anxiety
Time frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect on VR-biofeedback on anxiety
Time frame: Immediately after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect on VR-biofeedback on anxiety
Time frame: 15 minutes after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect on VR-biofeedback on anxiety
Time frame: 30 minutes after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-biofeedback on pain
Time frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of VR-biofeedback on medication use
Time frame: 24-90 hours
Amount of pain medications used will be collected
Effect of VR-distraction on anxiety
Time frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-distraction on anxiety
Time frame: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-distraction on anxiety
Time frame: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-distraction on anxiety
Time frame: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-distraction on pain
Time frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of VR-distraction on medication use
Time frame: 24-90 hours
Pain medications used will be collected
2 secondary outcomes
Role of anxiety on changes in pain
Time frame: One time prior to study visit
Role of pain catastrophizing
Time frame: One time prior to study visit
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 8 Feb 2023.
Related trials for Appendix Rupture
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Recruiting
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Appendicitis Acute, Appendicitis Perforated
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.
Vanessa Olbrecht, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Biofeedback and VR-Distraction in people with Appendix Rupture and Pain, run by Children's Hospital Medical Center, Cincinnati 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 5 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 8 Feb 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 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?
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?
Effect on VR-biofeedback on anxiety (time frame: Before 10 minute VR session.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.