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

Anxiety Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820700
• Other study ID #: VRHICUliège
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2018
• Est. completion date: December 28, 2020

Study information

• Verified date: January 2020
• Source: University of Liege
• Contact: Floriane Rousseaux
• Phone: 003243663462
• Email: floriane.rousseaux[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fatigue
• Pain, Postoperative
• Thoracic Surgery

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	University of Liège	Liège	Province De Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)