Virtual Reality Hypnosis for Thoracic Drain Insertion

Pneumopathy Clinical Trial

— VeRHiTY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478253
• Other study ID #: 2019-A02677-50
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: January 2022

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arnaud GALBOIS, MD
• Phone: 01 69 39 15 53
• Email: galbois[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pneumopathy

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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