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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation

NCT05815056

Oncology

COMPLETED NA

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in a Clinical Population

NCT05362708

Cancer

UNKNOWN NA

Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality

NCT04107558

Digital Sedation

COMPLETED NA

Utilization of Virtual Reality to Increase Comfort and Reduce Procedural Distress During Port Insertion Into the Body

NCT06927804

Oncology Patients

RECRUITING NA

Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation

NCT05140707

Pain Anxiety Blood Pressure +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Virtual reality hypnosis

Intervention Type DEVICE

Virtual reality hypnosis

Control

Usual care. Local anesthesia only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual reality hypnosis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No