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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820700
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Audrey Vanhaudenhuyse, 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 .


Condition or disease Intervention/treatment Phase
Thoracic Surgery Pain, Postoperative Anxiety Fatigue Behavioral: Hypnosis (Hypn) Behavioral: Virtual reality (VR) Behavioral: Virtual reality hypnosis (VRH) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : October 6, 2018
Estimated Primary Completion Date : December 28, 2020
Estimated Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control group
[Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
Experimental: Hypnosis (Hypn)
[Randomized] Patients will receive a hypnosis recorded audiotape.
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.

Experimental: Virtual reality (VR)
[Randomized] Patients will see a 3D movie with a beautiful landscape.
Behavioral: 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.

Experimental: Virtual reality hypnosis (VRH)
[Randomized] Patients will see the same 3D film combined with a hypnotic voice.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Physiological parameters [ Time Frame: 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

  2. Fatigue [ 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 fatigue = 0, maximum fatigue = 10.

  3. Relaxation [ 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 relaxation = 0, maximum relaxation = 10.


Other Outcome Measures:
  1. Participant's tendency to be absorbed and dissociated [ Time Frame: Day-1 before surgery (T0 before the intervention) ]
    Dissociative Experience Scale (DES) 28-items (Beirnstein, 1986). This scale measures the dissociative experiences someone can experiment in everyday life.

  2. Participant's opinion about the tool [ Time Frame: Day-1 before surgery (T1 after the intervention) ]
    Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not.

  3. Level of absorption at the moment [ Time Frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention) ]
    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.

  4. Level of dissociation at the moment [ Time Frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention) ]
    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.

  5. Time perception [ Time Frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention) ]
    We will ask to the patient his perception of time during the session.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820700


Contacts
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Contact: Floriane Rousseaux 003243663462 floriane.rousseaux@uliege.be

Locations
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Belgium
University of Liège Recruiting
Liège, Province De Liège, Belgium, 4000
Contact: Floriane Rousseaux    003243663462    floriane.rousseaux@uliege.be   
Sponsors and Collaborators
University of Liege
Investigators
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Study Director: Audrey Vanhaudenhuyse, PhD CHU of Liège
Study Director: Anne-Sophie Nyssen, Professor University of Liege
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Responsible Party: Audrey Vanhaudenhuyse, PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department, University of Liege
ClinicalTrials.gov Identifier: NCT03820700    
Other Study ID Numbers: VRHICUliège
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Audrey Vanhaudenhuyse, University of Liege:
Virtual Reality
Hypnosis
Intensive care units
Cardiac surgery
Anxiety
Pain
Cognition and perception
Recovery
Additional relevant MeSH terms:
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Pain, Postoperative
Anxiety Disorders
Mental Disorders
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations