Clinical trial NCT06883786: Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure
Official title: Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients With Cancer Having to Undergo an Invasive Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: HypnoVR
name: Centre Hospitalier Regional de Huy
name: University hospital of Liège
First posted: 2025-03-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: Inclusion Criteria:

* 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).
* Patient under 18 years old.
* Phobia of deep water.
* Dizziness.

Primary outcomes:
measure: Anxiety state
timeFrame: Before PAC intervention, immediately after PAC intervention
measure: Pain intensity
timeFrame: Before PAC intervention, immediately after PAC intervention
measure: Pain unpleasantness
timeFrame: Before PAC intervention, immediately after PAC intervention
measure: Comfort
timeFrame: Before PAC intervention, immediately after PAC intervention
Secondary outcomes:
measure: Anxiety trait
timeFrame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
measure: Dissociation trait
timeFrame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
measure: Dissociation state
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Absorption trait
timeFrame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
measure: Absorption state
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Time perception
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Immersion tendencies
timeFrame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
measure: Satisfaction of the participant
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Satisfaction of the surgeon
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Medication
timeFrame: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
measure: Surgery duration
timeFrame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
measure: Fatigue
timeFrame: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Other outcomes:
Locations:
city: Huy
country: Belgium
facility: CHR de Huy
state: Liège
city: Liège
country: Belgium
facility: CHU of Liège
Study officials:
References: