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

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.

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 .

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Fatigue; Anxiety; Thoracic Surgery
• Intervention / Treatment: Behavioral: Hypnosis (Hypn); Behavioral: Virtual reality (VR); Behavioral: Virtual reality hypnosis (VRH)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Floriane Rousseaux; Phone Number: 003243663462; Email: floriane.rousseaux@uliege.be

Study Locations

• Belgium
  • Province De Liège
    • Liège, Province De Liège, Belgium, 4000
      • Recruiting
      • University of Liege
      • Contact: Floriane Rousseaux; Phone Number: 003243663462; Email: floriane.rousseaux@uliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; [Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
Experimental: Hypnosis (Hypn); [Randomized] Patients will receive a hypnosis recorded audiotape.	Behavioral: Hypnosis (Hypn); 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.
Experimental: Virtual reality (VR); [Randomized] Patients will see a 3D movie with a beautiful landscape.	Behavioral: Virtual reality (VR); 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.
Experimental: Virtual reality hypnosis (VRH); [Randomized] Patients will see the same 3D film combined with a hypnotic voice.	Behavioral: Virtual reality hypnosis (VRH); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.	Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Pain perception	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.	Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters	Arterial pressure, heartbeat, pupil size, oxygen saturation, respiratory rates	Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Fatigue	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.	Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Relaxation	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.	Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's tendency to be absorbed and dissociated	Dissociative Experience Scale (DES) 28-items (Beirnstein, 1986). This scale measures the dissociative experiences someone can experiment in everyday life.	Day-1 before surgery (T0 before the intervention)
Participant's opinion about the tool	Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not.	Day-1 before surgery (T1 after the intervention)
Level of absorption at the moment	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.	Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
Level of dissociation at the moment	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.	Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
Time perception	We will ask to the patient his perception of time during the session.	Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Audrey Vanhaudenhuyse, PhD, CHU of Liège; Study Director: Anne-Sophie Nyssen, Professor, University of Liege

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2018
• Primary Completion (Anticipated): December 28, 2020
• Study Completion (Anticipated): December 28, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Recovery; Hypnosis; Virtual Reality; Cardiac surgery; Intensive care units; Cognition and perception
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: VRHICUliège

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No