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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Liege
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Anxiety
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Control group
[Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
Hypnosis (Hypn)
[Randomized] Patients will receive a hypnosis recorded audiotape.
Intervention: Hypnosis (Hypn) (Behavioral)
Virtual reality (VR)
[Randomized] Patients will see a 3D movie with a beautiful landscape.
Intervention: Virtual reality (VR) (Behavioral)
Virtual reality hypnosis (VRH)
[Randomized] Patients will see the same 3D film combined with a hypnotic voice.
Intervention: Virtual reality hypnosis (VRH) (Behavioral)
Outcomes
Primary Outcomes
Anxiety
Time Frame: 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
Time Frame: 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 Outcomes
- Physiological parameters(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
- Relaxation(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
- Fatigue(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
Investigators
Audrey Vanhaudenhuyse
PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department
University of Liege
