search
Back to results

Virtual Reality Hypnosis for Thoracic Drain Insertion (VeRHiTY)

Primary Purpose

Pneumopathy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HypnoVR
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient 18 years of age or older, having read and signed the consent form for participation in the study
  • Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.

Exclusion Criteria:

  • Patient under legal protection, guardianship or trusteeship
  • Pregnant or breastfeeding patient
  • Patient not affiliated to the French social security system
  • Hearing or visual disturbances contraindicating the use of virtual reality headphones
  • Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
  • Unbalanced epilepsy
  • Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol
  • Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion)
  • Concurrent participation in other research or during a period of exclusion from previous research

Sites / Locations

  • Hôpital Privé Claude GalienRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HypnoVR

Usual care

Arm Description

Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Insertion of the drain according to the usual management protocol

Outcomes

Primary Outcome Measures

Pain intensity progression
The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.

Secondary Outcome Measures

Evolution of pain measured on a simple numerical scale over 24 hours
Evolution of pain over 24 hours measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
Pain distress during the procedure and evolution from basal state. The patient will rate how much pain during the procedure was distressing or annoying on a simple numerical scale ranging from 0 (not at all) to 10 (very annoying or upsetting). It will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 24 hours.
Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status
Anxiety level measured on a simple numerical scale graduated from 0 (no anxiety) to 10 (worst imaginable anxiety) and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status. The simple numerical scale graded from 0 (no anxiety) to 10 (worst imaginable anxiety) will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h. The STAI-Y scale has 20 items evaluated from 1 to 4 according to its intensity (1= NO, 2 = rather NO, 3 = rather YES, 4 = YES) will be evaluated in the basal state 15 min before drainage then immediately after insertion and after 24 hours.
Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Evaluation of sleep quality measured on a simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.

Full Information

First Posted
July 2, 2020
Last Updated
August 16, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
search

1. Study Identification

Unique Protocol Identification Number
NCT04478253
Brief Title
Virtual Reality Hypnosis for Thoracic Drain Insertion
Acronym
VeRHiTY
Official Title
Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.
Detailed Description
This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted: Group 1: Insertion of the drain according to the usual management protocol. Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HypnoVR
Arm Type
Experimental
Arm Description
Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Insertion of the drain according to the usual management protocol
Intervention Type
Device
Intervention Name(s)
HypnoVR
Intervention Description
Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
Primary Outcome Measure Information:
Title
Pain intensity progression
Description
The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Evolution of pain measured on a simple numerical scale over 24 hours
Description
Evolution of pain over 24 hours measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
Time Frame
24 hours
Title
Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
Description
Pain distress during the procedure and evolution from basal state. The patient will rate how much pain during the procedure was distressing or annoying on a simple numerical scale ranging from 0 (not at all) to 10 (very annoying or upsetting). It will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 24 hours.
Time Frame
24 hours
Title
Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status
Description
Anxiety level measured on a simple numerical scale graduated from 0 (no anxiety) to 10 (worst imaginable anxiety) and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status. The simple numerical scale graded from 0 (no anxiety) to 10 (worst imaginable anxiety) will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h. The STAI-Y scale has 20 items evaluated from 1 to 4 according to its intensity (1= NO, 2 = rather NO, 3 = rather YES, 4 = YES) will be evaluated in the basal state 15 min before drainage then immediately after insertion and after 24 hours.
Time Frame
24 hours
Title
Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Description
Evaluation of sleep quality measured on a simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Time Frame
24 hours
Title
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Description
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient 18 years of age or older, having read and signed the consent form for participation in the study Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient. Exclusion Criteria: Patient under legal protection, guardianship or trusteeship Pregnant or breastfeeding patient Patient not affiliated to the French social security system Hearing or visual disturbances contraindicating the use of virtual reality headphones Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient Unbalanced epilepsy Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion) Concurrent participation in other research or during a period of exclusion from previous research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud GALBOIS, MD
Phone
01 69 39 15 53
Ext
33
Email
galbois@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michel MUSDAGI, MD
Email
musdagi.m@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud GALBOIS, MD
Organizational Affiliation
Hôpital Privé Claude Galien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Privé Claude Galien
City
Quincy-sous-Sénart
ZIP/Postal Code
91480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud GALBOIS, MD
First Name & Middle Initial & Last Name & Degree
Michel MUSDAGI, MD

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality Hypnosis for Thoracic Drain Insertion

We'll reach out to this number within 24 hrs