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

Not Applicable

• Conditions: Thoracic Surgery; Pain, Postoperative; Anxiety; Fatigue
• Interventions: Behavioral: Hypnosis (Hypn); Behavioral: Virtual reality (VR); Behavioral: Virtual reality hypnosis (VRH)

• Registration Number: NCT03820700
• Lead Sponsor: University of Liege

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).

Study Timeline

• Study Start: 2018-10-06
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-12-28
• Study Completion: 2020-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis (Hypn)	Hypnosis (Hypn)	\[Randomized\] Patients will receive a hypnosis recorded audiotape.
Virtual reality (VR)	Virtual reality (VR)	\[Randomized\] Patients will see a 3D movie with a beautiful landscape.
Virtual reality hypnosis (VRH)	Virtual reality hypnosis (VRH)	\[Randomized\] Patients will see the same 3D film combined with a hypnotic voice.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Liège; 🇧🇪 Liège, Province De Liège, Belgium