Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2021-04-15
2024-02-29
Brief Summary
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Detailed Description
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It is proposed that using hypnosis with 3D virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients.
Remifentanil is an opioid commonly used for lithotripsy. Shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. Opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting
It is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.
The study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3D virtual reality headset (intervention) or no hypnosis and no 3D virtual reality headset (control group).
Patients will be followed up prior to hospital discharge to assess their remifentanil use and pain, anxiety, comfort and their satisfaction with 3D virtual reality headset.
This new device is a non-pharmacological adjunct and can reduce pain intensity during procedure, reduce opioid use and length of stay in hospital and improve the patient experience whilst potentially reducing complications of intravenous opioid.
This study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D virtual reality
Use of Hypnosis 3D virtual reality headset
Hypnosis 3D virtual reality headset
3D experience to journey through a natural and therapeutic environment. Immersion is amplified by the realism of 3D environment, a soothing sound atmosphere and specific medical hypnosis.
Control
Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone
No interventions assigned to this group
Interventions
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Hypnosis 3D virtual reality headset
3D experience to journey through a natural and therapeutic environment. Immersion is amplified by the realism of 3D environment, a soothing sound atmosphere and specific medical hypnosis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Deafness, Blindness
* Schizophrenia, Hallucinations
* No french-speaking
* Autistic
* Motion sickness
18 Years
ALL
No
Sponsors
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GAMIDA
UNKNOWN
Healthy Mind
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Darless Clausse, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital européen Geroges-Pompidou
Locations
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Assistance Publique Hôpitaux de Paris, Necker
Paris, , France
Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Darless Clausse, MD
Role: primary
References
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Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
Scapin S, Echevarria-Guanilo ME, Boeira Fuculo Junior PR, Goncalves N, Rocha PK, Coimbra R. Virtual Reality in the treatment of burn patients: A systematic review. Burns. 2018 Sep;44(6):1403-1416. doi: 10.1016/j.burns.2017.11.002. Epub 2018 Feb 1.
Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.
Other Identifiers
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IDRCB 2020-A02052-37
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200879
Identifier Type: -
Identifier Source: org_study_id
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