Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.
VRHypnICU
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.
1 other identifier
interventional
100
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2018
CompletedFirst Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2020
CompletedJanuary 3, 2020
January 1, 2020
2.2 years
December 20, 2018
January 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (3)
Physiological parameters
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)
Relaxation
Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Other Outcomes (5)
Participant's tendency to be absorbed and dissociated
Day-1 before surgery (T0 before the intervention)
Participant's opinion about the tool
Day-1 before surgery (T1 after the intervention)
Level of absorption at the moment
Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
- +2 more other outcomes
Study Arms (4)
Control group
NO INTERVENTION\[Randomized\] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
Hypnosis (Hypn)
EXPERIMENTAL\[Randomized\] Patients will receive a hypnosis recorded audiotape.
Virtual reality (VR)
EXPERIMENTAL\[Randomized\] Patients will see a 3D movie with a beautiful landscape.
Virtual reality hypnosis (VRH)
EXPERIMENTAL\[Randomized\] Patients will see the same 3D film combined with a hypnotic voice.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Adults undergoing cardiac surgery
- Who have given consent for their participation.
You may not qualify if:
- Psychiatric antecedents
- Claustrophobia
- Acrophobia,
- Heavy hearing
- Visual impairment
- Infectious cases (example: conjunctivitis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Liège
Liège, Province De Liège, 4000, Belgium
Related Publications (2)
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.
PMID: 34783683DERIVEDRousseaux 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.
PMID: 32293517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Audrey Vanhaudenhuyse, PhD
CHU of Liège
- STUDY DIRECTOR
Anne-Sophie Nyssen, Professor
University of Liege
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department
Study Record Dates
First Submitted
December 20, 2018
First Posted
January 29, 2019
Study Start
October 6, 2018
Primary Completion
December 28, 2020
Study Completion
December 28, 2020
Last Updated
January 3, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share