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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04478253
Other study ID # 2019-A02677-50
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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