Virtual Reality Hypnosis for Thoracic Drain Insertion

NCT04478253 | Completed

• 1 other identifier: 2019-A02677-50
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evolution of pain measured on a simple numerical scale over 24 hours

  24 hours

• Pain distress measured on a simple numerical scale during the procedure and evolution from basal state

  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

  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.

  24 hours

• Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.

  24 hours

Study Arms (2)

HypnoVR

EXPERIMENTAL

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

Device: HypnoVR

Usual care

NO INTERVENTION

Insertion of the drain according to the usual management protocol

Interventions

HypnoVR DEVICE

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

HypnoVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Arnaud GALBOIS, MD

  Hôpital Privé Claude Galien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 20, 2020
• Study Start: May 23, 2020
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

FR (1)