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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
102
Virtual reality hypnosis
CHR de Huy
Huy, Liège, Belgium
CHU of Liège
Liège, Liège, Belgium
Anxiety state
Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Time frame: Before PAC intervention, immediately after PAC intervention
Pain intensity
Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Before PAC intervention, immediately after PAC intervention
Pain unpleasantness
Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Before PAC intervention, immediately after PAC intervention
Comfort
Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).
Time frame: Before PAC intervention, immediately after PAC intervention
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.
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
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.
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Dissociation state
Dissociation will be assessed using a numerical rating scale (NRS) ranging from 0 (no dissociation) to 10 (maximum dissociation).
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
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.
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Absorption state
Absorption will be assessed using a numerical rating scale (NRS) ranging from 0 (no Absorption) to 10 (maximum Absorption).
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Time perception
Time perception will be assessed with an open-ended question.
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Immersion tendencies
Immersion propensity is the amount of sensory input the virtual reality system creates. Will be assessed with the Immersion Propensity questionnaire. The higher the score, the more one is immersed in the virtual environments.
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Satisfaction of the participant
Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Satisfaction of the surgeon
Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Medication
The medication will be collected in the medical record of the surgery.
Time frame: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Surgery duration
The duration of the surgery will be collected in the medical record of the surgery.
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Fatigue
Fatigue will be assessed using a numerical rating scale (NRS) ranging from 0 (no fatigue) to 10 (worst fatigue ever).
Time frame: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
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