Clinical trial NCT03820700: Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery
Pain, Postoperative
Anxiety
Fatigue
Keywords: Virtual Reality
Hypnosis
Intensive care units
Cardiac surgery
Anxiety
Pain
Cognition and perception
Recovery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: Anxiety
timeFrame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
measure: Pain perception
timeFrame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Secondary outcomes:
measure: Physiological parameters
timeFrame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
measure: Fatigue
timeFrame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
measure: Relaxation
timeFrame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Other outcomes:
measure: Participant's tendency to be absorbed and dissociated
timeFrame: Day-1 before surgery (T0 before the intervention)
measure: Participant's opinion about the tool
timeFrame: Day-1 before surgery (T1 after the intervention)
measure: Level of absorption at the moment
timeFrame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
measure: Level of dissociation at the moment
timeFrame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
measure: Time perception
timeFrame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
Locations:
city: Liège
country: Belgium
facility: University of Liège
state: Province De Liège
Study officials:
affiliation: CHU of Liège
name: Audrey Vanhaudenhuyse, PhD
role: STUDY_DIRECTOR
affiliation: University of Liege
name: Anne-Sophie Nyssen, Professor
role: STUDY_DIRECTOR
References:
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.
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.