About this trial
The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Low auditory and/or visual acuity precludes the use of the device.
Head or face wounds precluding the use of the device.
Schizophrenia, dissociative disorder or any other psychiatric disorder.
Non-proficiency in French (Research language).
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Virtual reality hypnosis
DeviceVirtual reality hypnosis
Treatment groups
Trial outcomes
Primary outcomes
Anxiety state
Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Pain intensity
Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Pain unpleasantness
Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Comfort
Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).
Secondary outcomes
Anxiety trait
The State-Trait Anxiety Inventory (STAI - Y) will be used to assess trait anxiety only. Originally this questionnaire has two parts one dedicated to assess state anxiety and another to assess the trait anxiety. Only the latter was used in this study. STAI - Y Trait contains 20 items with 4 response options (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). Total scores can range from 20 to 80, with higher scores indicating a higher level of anxiety.
Dissociation trait
The Dissociative Experience Scale is a self-reported questionnaire used to evaluate the presence, quantity, and type of dissociative experiences one might live in daily life. It consists of 28 items arranged on an analog scale (from 0 to 100% measuring the frequency of dissociative experiences), and the total score ranges from 0 to 100. There is a cutoff of 45 as a mean score to suggest a dissociative disorder. This questionnaire is not a diagnostic instrument; it is designed only for screening, but it can suggest that a specific clinical assessment is needed.
Dissociation state
Dissociation will be assessed using a numerical rating scale (NRS) ranging from 0 (no dissociation) to 10 (maximum dissociation).
Absorption trait
The Tellegen Absorption Scale consists of 34 true/false items , aiming to measure the absorption of a person, meaning the disposition for having episodes of a deep involvement that engage all the subject's resources (perceptual, imaginative, and cognitive). The total score range is from 0 to 34. The higher the score, the more one has a high propensity for absorption.
Sponsors and contacts
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University of Liege
Lead sponsor
HypnoVR
Collaborator
Centre Hospitalier Regional de Huy
Collaborator
University hospital of Liège
Collaborator
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