Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure (VRH-PAC)

Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients with Cancer Having to Undergo an Invasive Intervention

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Virtual reality hypnosis

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey Vanhaudenhuyse, PhD; Phone Number: + 32 43 23 80 33; Email: avanhaudenhuyse@chuliege.be
• Study Contact Backup: Name: Aminata Bicego, PhD; Phone Number: +32 43 66 34 99; Email: abicego@uliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Chu of Liège
    • Contact: Aminata Bicego, PhD; Phone Number: 003243663499; Email: abicego@uliege.be
    • Contact: Audrey Vanhaudenhuyse, PI; Phone Number: 003243668033; Email: avanhaudenhuyse@chuliege.be
    • Contact: Yanis Mouheb, M.Sc.
  • Liège
    • Huy, Liège, Belgium, 4500
      • CHR de Huy
      • Contact: Jean-François Dr. Maillart, M.D.; Phone Number: +3285277154; Email: jf.maillart@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality hypnosis; The VRH session, called Aqua+© (120 Version 1.1, HypnoVR SAS, Strasbourg, France) It is an immersive and contemplative virtual experience combining music, sounds, and/or a vocal audio recording relating a hypnotic scenario and a 3D virtual video. The Aqua© VRH session follows the standard phases of hypnosis, beginning with induction, followed by suggestions, and ending with the exit of hypnosis.	Device: Virtual reality hypnosis; Virtual reality hypnosis
No Intervention: Control; Usual care. Local anesthesia only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety state	Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).	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).	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).	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).	Before PAC intervention, immediately after PAC intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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).	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.	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.	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).	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).	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.	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.	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).	24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: HypnoVR; Centre Hospitalier Regional de Huy; University hospital of Liège

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VRH-PAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No