Virtual Reality Hypnosis Distraction Utility to Improve Tolerance to Regional Anaesthesia

NCT04024904 | Completed DMC

• 1 other identifier: B406201836302
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Regional anaesthesia has many advantages but it might be a stressful and painful experience. Usually, the anesthetist administers a pharmacologic intravenous sedation to achieve patient's comfort. Though, these medications are not benign, and disadvantages include unpredictable response, adverse effects, and interference with cooperation. The virtual reality hypnosis distraction (VRHD) could be a good non-pharmacological technique to improve patient's comfort, decrease anxiety and procedure related pain. This study is a prospective study where sixty patients scheduled for orthopedic surgery requiring regional anesthesia were randomized in three groups according to the use or not of VRHD during the regional procedure or before as a complementary premedication. The anesthetic management during the regional procedure and the surgery remained otherwise standard for each patient. The first endpoint is the proportion of patients receiving pharmacological sedation (in the VRHD groups compared to the pharmacological sedation group). . The second endpoint is to determine if the VRHD increases the patient's satisfaction of their anaesthetic management. The third endpoint is to study various parameters of use of this specific anaesthetic management: time required for the installation and operation time of the VRHD device; the variation of haemodynamic parameters between the separate groups; pain procedure-related and behavioural pain scale scores between the separate groups.

Conditions

Anesthesia

Keywords

regional anesthesia; virtual reality; hypnosis; distraction

Outcome Measures

Primary Outcomes (1)

• Proportion of patients receiving pharmacological sedation

  Collecting the proportion of patients (n) receiving pharmacological sedation as opioids (micrograms) and benzodiazepine (milligrams) from the beginning to the end of the regional procedure.

  immediately after the regional procedure

Secondary Outcomes (1)

• patient's satisfaction with visual analogue scale(VAS) (a range of scores from 0-10)

  immediately after regional procedure

Other Outcomes (6)

• placement of the VRHD (virtual Reality Hypnosis Distraction) device

  once, before the regional procedure

• heart rate before (bpm)

  once, before the regional procedure

• heart rate after (bpm)

  immediately after the regional procedure

Study Arms (3)

control group

NO INTERVENTION

In the control group, the patient received the standard pharmacologic intravenous sedation before the regional anaesthesia (2 mg midazolam + 5 µg de sufentanil) without VRHD (Virtual Reality Hypnosis Distraction).

VRHD1

EXPERIMENTAL

In the study group VRHD (Virtual Reality Hypnosis Distraction) 1, the patient received the VHRD technique during the peripheral nerve block and received a pharmacologic intravenous sedation only if the patient's asked for it or if the patient shows some discomfort (behavioural pain scale score \>3).

Device: OncomfortTM device

VRHD2

EXPERIMENTAL

In the study group VRHD (Virtual Reality Hypnosis Distraction) 2, the patient received the VHRD technique for the first time before the regional procedure and a second time during the peripheral nerve block. The patient received a pharmacologic intravenous sedation only if the patient's asked for it or if the patient shows some discomfort (behavioural pain scale score \>3).

Device: OncomfortTM device

Interventions

OncomfortTM device DEVICE

The VHRD (Virtual Reality Hypnosis Distraction) technique is the program of OncomfortTM (Oncomfort Inc, Houston, USA). The OncomfortTM device include the hyper vision 3D virtual reality glasses and disposable single-patient-use headphones. The program is an immersive experience focused on inducing relaxation environment and this program exist in 5,15 and 30 minutes

VRHD1; VRHD2

Eligibility Criteria

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

You may qualify if:

• undergoing elective orthopedic surgery with regional anaesthesia (peripheral nerve block), were aged ≥ 18 years

You may not qualify if:

• ASA (American Society of anesthesiologists) IV, spinal anesthesia, claustrophobia, blindness, deafness, unable to complete a satisfaction survey, previously documented history of neurologic disease, lack of written informed consent, urgent surgery, allergy to a drug used within the study, ongoing pregnancy, patient's infectious isolation

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

ULB-Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (17)

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  PMID: 17321932 RESULT

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  PMID: 17074626 RESULT

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  PMID: 26905874 RESULT

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  PMID: 17456675 RESULT

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  PMID: 27173407 RESULT

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  PMID: 20737029 RESULT

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  PMID: 20691523 RESULT

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  PMID: 28356241 RESULT

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  PMID: 19272275 RESULT

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  PMID: 16640481 RESULT

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  PMID: 11708732 RESULT

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  PMID: 20022431 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients were coached by a separate practitioner aside from the regional anaesthesiologist performing the regional block. The anesthetists in charge of the patient were not blinded, but data collection and statistical analysis were blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, attending physician

Model Details: The Virtual Hypnosis Reality Distraction (VHRD) technique is the program of OncomfortTM (Oncomfort Inc, Houston, USA). The OncomfortTM device include the hyper vision 3D virtual reality glasses and disposable single-patient-use headphones. The program is an immersive experience focused on inducing relaxation environment and this program exist in 5,15 and 30 minutes. In the group VHRD 1 and 2 we use the program throughout the regional block. The time choose for the VHRD program is 15 or 30 min depending of the time required for the regional procedure. In the group VHRD 2, we use the program of 5 min and we applied the device before the regional procedure.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: July 18, 2019
• Study Start: July 26, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)