NCT04869293

Brief Summary

The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

March 19, 2021

Last Update Submit

April 14, 2023

Conditions

Renal CalculiPain

Keywords

therapeutic virtual realityhypnosis

Outcome Measures

Primary Outcomes (1)

  • Remifentanil use

    Remifentanil consumption (microgram) during shock wave lithotripsy

    Hour 1

Secondary Outcomes (1)

  • Maximal level of pain during shock wave lithotripsy

    Hour 1

Study Arms (2)

3D virtual reality

EXPERIMENTAL

Use of Hypnosis 3D virtual reality headset

Device: Hypnosis 3D virtual reality headset

Control

NO INTERVENTION

Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone

Interventions

Hypnosis 3D virtual reality headsetDEVICE

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.

3D virtual reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Shock wave lithotripsy and outpatient surgery

You may not qualify if:

  • Epilepsy
  • Deafness, Blindness
  • Schizophrenia, Hallucinations
  • No french-speaking
  • Autistic
  • Motion sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assistance Publique Hôpitaux de Paris, Necker

Paris, France

NOT YET RECRUITING

Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31136330BACKGROUND

  • 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.

    PMID: 29395400BACKGROUND

  • 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.

    PMID: 30052655BACKGROUND

MeSH Terms

Conditions

Kidney CalculiPain

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Darless Clausse, MD

    Hôpital européen Geroges-Pompidou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darless Clausse, MD

CONTACT

331 56 09 54 11darless.clausse@aphp.fr

Natacha Nohilé

CONTACT

331 56 09 59 82natacha.nohile@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

May 3, 2021

Study Start

April 15, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(2)