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

University of Liege

Status: Unknown

Conditions: Pain, Postoperative; Fatigue; Anxiety; Thoracic Surgery

Treatments: Behavioral: Virtual reality hypnosis (VRH); Behavioral: Virtual reality (VR); Behavioral: Hypnosis (Hypn)

Study type: Interventional

Funder types: Other

Identifiers

NCT03820700

VRHICUliège

Details and patient eligibility

About

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 .

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Control group

No Intervention group

Description:

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

Hypnosis (Hypn)

Experimental group

Description:

\[Randomized\] Patients will receive a hypnosis recorded audiotape.

Treatment:

Behavioral: Hypnosis (Hypn)

Virtual reality (VR)

Experimental group

Description:

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

Treatment:

Behavioral: Virtual reality (VR)

Virtual reality hypnosis (VRH)

Experimental group

Description:

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

Treatment:

Behavioral: Virtual reality hypnosis (VRH)