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Completed

NCT Number: NCT04478253

Virtual Reality Hypnosis for Thoracic Drain Insertion

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.

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Key information

Conditions

Pneumopathy Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HypnoVR

Device

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

Primary outcomes

  1. Pain intensity progression

    Time frame: 24 hours

    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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 24 hours

    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.

  3. 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

    Time frame: 24 hours

    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.

  4. 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.

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: VeRHiTY

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2020
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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