Clinical trial NCT04478253: Virtual Reality Hypnosis for Thoracic Drain Insertion
Official title: Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumopathy
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Pain intensity progression
timeFrame: 24 hours
Secondary outcomes:
measure: Evolution of pain measured on a simple numerical scale over 24 hours
timeFrame: 24 hours
measure: Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
timeFrame: 24 hours
measure: 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
timeFrame: 24 hours
measure: 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.
timeFrame: 24 hours
measure: Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
affiliation: Hôpital Privé Claude Galien
name: Arnaud GALBOIS, MD
role: PRINCIPAL_INVESTIGATOR
References: