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

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06883786
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-15
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-04
• Primary Completion: 2026-08
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety state	Before PAC intervention, immediately after PAC intervention	Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Pain intensity	Before PAC intervention, immediately after PAC intervention	Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Pain unpleasantness	Before PAC intervention, immediately after PAC intervention	Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Comfort	Before PAC intervention, immediately after PAC intervention	Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).

Secondary Outcome Measures

Name	Time	Method
Anxiety trait	From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks	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	From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks	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	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	Dissociation will be assessed using a numerical rating scale (NRS) ranging from 0 (no dissociation) to 10 (maximum dissociation).
Absorption trait	From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks	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.
Absorption state	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	Absorption will be assessed using a numerical rating scale (NRS) ranging from 0 (no Absorption) to 10 (maximum Absorption).
Time perception	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	Time perception will be assessed with an open-ended question.
Immersion tendencies	From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks	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.
Satisfaction of the participant	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Satisfaction of the surgeon	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Medication	During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC	The medication will be collected in the medical record of the surgery.
Surgery duration	From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks	The duration of the surgery will be collected in the medical record of the surgery.
Fatigue	24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC	Fatigue will be assessed using a numerical rating scale (NRS) ranging from 0 (no fatigue) to 10 (worst fatigue ever).

Trial Locations

Locations (2)

CHR de Huy; 🇧🇪 Huy, Liège, Belgium

CHU of Liège; 🇧🇪 Liège, Belgium