Last reviewed · How we verify
NCT05527379: RV-CIP
Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
NA trial testing Virtual reality in Anxiety in 120 participants. Completed in 20 December 2023.
20 December 2023
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 5 January 2023 |
| Primary completion | 20 December 2023 |
| Estimated completion | 20 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Virtual reality
Conditions studied
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Anxiety or CIP. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses. The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology). Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication. The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05527379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Virtual reality
Trials testing the same drug.
- NCT06955338 — Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children · NA · not yet recruiting
- NCT07408622 — Virtual Reality Therapy for Wrist and Hand Injury Recovery · NA · not yet recruiting
- NCT07483866 — The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiologica · NA · not yet recruiting
- NCT07371260 — Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acqui · NA · not yet recruiting
- NCT07343843 — Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes Duri · NA · recruiting
Other recruiting trials for Anxiety
Currently open trials in the same condition.
- NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
- NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT07425951 — Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years · NA · recruiting
- NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05527379 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 22 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05527379.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing