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Not yet recruiting NCT06883786

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

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality hypnosis.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Virtual reality hypnosis
    Virtual reality hypnosis

Primary outcome measures

  • Anxiety state [Time frame: Before PAC intervention, immediately after PAC intervention]
  • Pain intensity [Time frame: Before PAC intervention, immediately after PAC intervention]
  • Pain unpleasantness [Time frame: Before PAC intervention, immediately after PAC intervention]
  • Comfort [Time frame: Before PAC intervention, immediately after PAC intervention]
Secondary outcome measures (12)
  • Anxiety trait [Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
  • Dissociation trait [Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
  • Dissociation state [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Absorption trait [Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
  • Absorption state [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Time perception [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Immersion tendencies [Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
  • Satisfaction of the participant [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Satisfaction of the surgeon [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Medication [Time frame: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC]
  • Surgery duration [Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
  • Fatigue [Time frame: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Belgium · 2 centers
  • CHR de Huy — Huy
  • CHU of Liège — Liège

Identifiers

NCT: NCT06883786 · VRH-PAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗