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

NCT06883786 | Not Yet Recruiting DMC

• 1 other identifier: VRH-PAC
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Anxiety trait

  From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

• Dissociation trait

  From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

• Dissociation state

  From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

• Absorption trait

  From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

• Absorption state

  From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

Study Arms (2)

Virtual reality hypnosis

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care. Local anesthesia only.

Interventions

Virtual reality hypnosis DEVICE

Virtual reality hypnosis

Virtual reality hypnosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead
• HypnoVR: collaborator
• Centre Hospitalier Regional de Huy: collaborator
• University hospital of Liège: collaborator

Study Sites (2)

CHR de Huy

Huy, Liège, 4500, Belgium

Location

CHU of Liège

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Audrey Vanhaudenhuyse, PhD

CONTACT

+ 32 43 23 80 33; avanhaudenhuyse@chuliege.be

Aminata Bicego, PhD

CONTACT

+32 43 66 34 99; abicego@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 19, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

BE (2)