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Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery. (VRHypnICU)

Primary Purpose

Thoracic Surgery, Pain, Postoperative, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hypnosis (Hypn)
Virtual reality (VR)
Virtual reality hypnosis (VRH)
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thoracic Surgery focused on measuring Virtual Reality, Hypnosis, Intensive care units, Cardiac surgery, Anxiety, Pain, Cognition and perception, Recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults undergoing cardiac surgery
  • Who have given consent for their participation.

Exclusion Criteria:

  • Psychiatric antecedents
  • Claustrophobia
  • Acrophobia,
  • Heavy hearing
  • Visual impairment
  • Infectious cases (example: conjunctivitis)

Sites / Locations

  • University of LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Hypnosis (Hypn)

Virtual reality (VR)

Virtual reality hypnosis (VRH)

Arm Description

[Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.

[Randomized] Patients will receive a hypnosis recorded audiotape.

[Randomized] Patients will see a 3D movie with a beautiful landscape.

[Randomized] Patients will see the same 3D film combined with a hypnotic voice.

Outcomes

Primary Outcome Measures

Anxiety
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Pain perception
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.

Secondary Outcome Measures

Physiological parameters
Arterial pressure, heartbeat, pupil size, oxygen saturation, respiratory rates
Fatigue
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Relaxation
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.

Full Information

First Posted
December 20, 2018
Last Updated
January 2, 2020
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT03820700
Brief Title
Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.
Acronym
VRHypnICU
Official Title
The Influence of Non-pharmacological Medical Approaches Such as Hypnosis and Virtual Reality to Reduce Pain and Anxiety Before and After a Cardiovascular Surgery. A Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2018 (Actual)
Primary Completion Date
December 28, 2020 (Anticipated)
Study Completion Date
December 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Nowadays, the use of cognitive behavioral therapies has become quite common in the clinical care. Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of acute and chronic pain (Pourmand et al., 2017; Vanhaudenhuyse et al., 2009). A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are undergoing a cardiovascular surgery at the Liège University Hospital will be randomly assigned to four conditions (control, hypnosis, VR and VRH). Each participant will receive two sessions of one of the techniques: one the day before the surgery and one other session the day after, in intensive care units. Physiological parameters will be taken and participants will fill in a questionnaire which evaluates their level of perceived immersion, their level of anxiety, fatigue, pain and relaxation. A short interview will also be conducted to give participants the opportunity to openly describe their experience. This study will help to expand the knowledge regarding the influence of these techniques on patient's cognition, perception and sensation .
Detailed Description
Primary outcome (anxiety) and secondary outcomes (pain, fatigue, relaxation and physiological parameters) will be investigated at four measurement times: the day before the surgery (Day -1) before the intervention (T0: baseline) and after the intervention (T1); the day after the surgery (Day+1) before the intervention (T2) and after (T3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Pain, Postoperative, Anxiety, Fatigue
Keywords
Virtual Reality, Hypnosis, Intensive care units, Cardiac surgery, Anxiety, Pain, Cognition and perception, Recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
[Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
Arm Title
Hypnosis (Hypn)
Arm Type
Experimental
Arm Description
[Randomized] Patients will receive a hypnosis recorded audiotape.
Arm Title
Virtual reality (VR)
Arm Type
Experimental
Arm Description
[Randomized] Patients will see a 3D movie with a beautiful landscape.
Arm Title
Virtual reality hypnosis (VRH)
Arm Type
Experimental
Arm Description
[Randomized] Patients will see the same 3D film combined with a hypnotic voice.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis (Hypn)
Intervention Description
The hypnosis session will consist of a 20-minute hypnosis recording created by Marie-Elisabeth Faymonville and recorded by Anne-Sophie Nyssen, both professionals in hypnosis from University of Liège. The recording includes suggestions about relaxation, corporal sensations, respiratory techniques and visual imaginative stimuli about a beautiful landscape. With this tool, the hypnosis session is standardized for all patients and there is no need of a psychotherapist to deliver hypnosis.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality (VR)
Intervention Description
VR sessions. This session will consist in using a head-mounted 3D graphical display with goggles. With this tool, participants will be able to visualize a 3D immersive landscape for 20 minutes consisting of a shed near a lake at sunrise followed by a relaxing moment in the clouds. The session ends on the lake's edge.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality hypnosis (VRH)
Intervention Description
The combined tool sessions. Participants will be simultaneously subjected to the same hypnosis recording and 3D visual stimuli used in the Hypn and VR conditions.
Primary Outcome Measure Information:
Title
Anxiety
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Time Frame
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Title
Pain perception
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.
Time Frame
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Secondary Outcome Measure Information:
Title
Physiological parameters
Description
Arterial pressure, heartbeat, pupil size, oxygen saturation, respiratory rates
Time Frame
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Title
Fatigue
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Time Frame
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Title
Relaxation
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
Time Frame
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Other Pre-specified Outcome Measures:
Title
Participant's tendency to be absorbed and dissociated
Description
Dissociative Experience Scale (DES) 28-items (Beirnstein, 1986). This scale measures the dissociative experiences someone can experiment in everyday life.
Time Frame
Day-1 before surgery (T0 before the intervention)
Title
Participant's opinion about the tool
Description
Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not.
Time Frame
Day-1 before surgery (T1 after the intervention)
Title
Level of absorption at the moment
Description
Absorption will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). VAS is from 0 to 10. 0 is not absorbed and 10 is really absorbed. When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time Frame
Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
Title
Level of dissociation at the moment
Description
Dissociation will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time Frame
Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
Title
Time perception
Description
We will ask to the patient his perception of time during the session.
Time Frame
Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults undergoing cardiac surgery Who have given consent for their participation. Exclusion Criteria: Psychiatric antecedents Claustrophobia Acrophobia, Heavy hearing Visual impairment Infectious cases (example: conjunctivitis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Floriane Rousseaux
Phone
003243663462
Email
floriane.rousseaux@uliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Vanhaudenhuyse, PhD
Organizational Affiliation
CHU of Liège
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Nyssen, Professor
Organizational Affiliation
University of Liege
Official's Role
Study Director
Facility Information:
Facility Name
University of Liège
City
Liège
State/Province
Province De Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Floriane Rousseaux
Phone
003243663462
Email
floriane.rousseaux@uliege.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34783683
Citation
Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.
Results Reference
derived
PubMed Identifier
32293517
Citation
Rousseaux F, Faymonville ME, Nyssen AS, Dardenne N, Ledoux D, Massion PB, Vanhaudenhuyse A. Can hypnosis and virtual reality reduce anxiety, pain and fatigue among patients who undergo cardiac surgery: a randomised controlled trial. Trials. 2020 Apr 15;21(1):330. doi: 10.1186/s13063-020-4222-6.
Results Reference
derived

Learn more about this trial

Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.

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