Virtual Reality Hypnosis for Thoracic Drain Insertion (VeRHiTY)

Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.

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.

Study Overview

• Status: Completed
• Conditions: Pneumopathy
• Intervention / Treatment: Device: HypnoVR

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HypnoVR; Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).	Device: HypnoVR; Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
No Intervention: Usual care; Insertion of the drain according to the usual management protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
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.	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.	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.	24 hours
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.	24 hours

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Arnaud GALBOIS, MD, Hôpital Privé Claude Galien

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 2019-A02677-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No