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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03820700
Acronym
VRHypnICU
Enrollment
100
Registered
2019-01-29
Start date
2018-10-06
Completion date
2020-12-28
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery, Pain, Postoperative, Anxiety, Fatigue

Keywords

Virtual Reality, Hypnosis, Intensive care units, Cardiac surgery, Anxiety, Pain, Cognition and perception, Recovery

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).

Interventions

BEHAVIORALHypnosis (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.

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.

BEHAVIORALVirtual 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.

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
AnxietyDay-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 perceptionDay-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

MeasureTime frameDescription
Physiological parametersDay-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
FatigueDay-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.
RelaxationDay-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

MeasureTime frameDescription
Participant's tendency to be absorbed and dissociatedDay-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.
Level of absorption at the momentDay-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.
Participant's opinion about the toolDay-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.
Level of dissociation at the momentDay-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.
Time perceptionDay-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.

Countries

Belgium

Contacts

Primary ContactFloriane Rousseaux
floriane.rousseaux@uliege.be003243663462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026