AnxietyRV-CIPNCT05527379

Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter

A study testing Virtual reality in people with Anxiety and CIP, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety, CIP
What is being tested?: Virtual reality
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteFrance
Study dates: 5 Jan 2023to 20 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patient ≥18 years old
Patient operated on an outpatient basis and available for a phone call between D+1 and D+5
Patient operated for a 1st pose of CIP at the UAV
Patient whose anxiety measured by ENS Anxiety is at least 4/10 at entry
Patient having signed the Informed Consent
Patient affiliated to a social security

Who cannot join

Patient not sufficiently fluent in the French language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material;
Patient with motion sickness;
Patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol;
Patient deprived of liberty or placed under guardianship or curators;
Pregnant or breastfeeding women;
Patient with a history of epilepsy ;

Show all 10Show fewer

Patient with a pacemaker or pacemaker;
Patient with psychiatric disorders of a psychotic nature in the acute phase or visual hallucinations;
Patient under anxiolytic treatment;
Patient presenting wounds or infections on the level of the head not allowing the installation of the virtual reality helmet.

Trial locations and contacts

1 site in 1 country.

France1 site

Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS
Pierre-Bénite, 69495

Other trials in France

About this study

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..

Conditions: Anxiety, CIP
Being tested: Virtual reality
Keywords: virtual reality, anxiety, CIP
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual realityDevice
When the patient is ready to have the CIP procedure the tablet will be presented to him so that he can view and choose the immersive film that suits him best.
Before fitting the virtual reality helmet and the start of the film, the patient's anxiety will be evaluated by ENS on a scale of 0 to 10 . The patient's anxiety will also be evaluated at the end of the procedure.
The patient will be contacted by telephone by an investigator between D+1 and D+5 in order to reassess and remotely from the pose, his memorization of the gesture and to look for adverse events.

Study groups in NCT05527379
Study group	Role	What they receive
CIP procedure under virtual reality	Experimental	CIP procedure under virtual reality Receives: Device: Virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

Description of Patient's anxiety through his participation
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Measured: through study completion, an average of 5 days
Evolution of Patient's anxiety during the procedure
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Measured: Day 0

Secondary outcomes (9)

Effects of virtual reality on the pain perceived by the patient;
The patient's pain, over the entire procedure, measured by Simple Numerical Scale : Pain from 0 to 10
Measured: Day 0 (after placing the port)
Effects of virtual reality on Pulse
The Pulse of the patient
Measured: Day 0 (before, during and after placing the port)
Effects of virtual reality on Blood Pressure
The Blood Pressure of the patient (both systolic and diastolic)
Measured: Day 0 (before, during and after placing the port)
Effects of virtual reality on memorization of the gesture
Measured by a Likert scale (Likert scale = Very Uncomfortable- Uncomfortable- Comfortable- Very Comfortable)
Measured: Day 0 (after placing the port) and through study completion between D+1 and D+5
Effects of virtual reality on the perception of time
Perception of time in minutes estimated by the patient (In your opinion, how long did the gesture last? and difference with the actual duration of the gesture
Measured: Day 0 (after placing the port)
Effects of virtual reality on satisfaction and comfort during installation
Measured by a Simple Numerical Scale from 0 to 10
Measured: Day 0 (after placing the port)
Effects of virtual reality on the caregiver's perception of the ease of the gesture
Measured by a Likert scale, (Likert scale = Easy-patient Immobile - appearing relaxed / Moderately Easy-Patient slightly mobile- Reactive / Difficult-Patient having difficulty in staying Still- Very reactive- Seeming tense)
Measured: Day 0 (after placing the port)
Effects of virtual reality on caregiver satisfaction
Measured by a Simple Numerical Scale from 0 to 10
Measured: Day 0 (after placing the port)
Effects of virtual reality on the duration of the intervention
Duration of the procedure in minutes between the patient entering and leaving the operating room
Measured: Day 0 (after placing the port)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 202320 Dec 2023

First posted2 Sep 2022
Study start5 Jan 2023
Primary completion20 Dec 2023
Study completion20 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05527379
Sponsor's protocol ID: 69HCL19_0824
Acronym: RV-CIP
Status last verified: Dec 2023
First submitted: 24 Aug 2022
Last updated: 22 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
ClinicalTrials.gov ID: NCT05527379
Acronym / sponsor ID: RV-CIP / 69HCL19_0824
Conditions: Anxiety, CIP
Keywords: virtual reality, anxiety, CIP
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: 5 Jan 2023 (actual)
Primary completion: 20 Dec 2023 (actual)
Study completion: 20 Dec 2023 (actual)
First posted: 2 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CIP procedure under virtual reality	Experimental	Device: Virtual realityCIP procedure under virtual reality

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult patient ≥18 years old
Patient operated on an outpatient basis and available for a phone call between D+1 and D+5
Patient operated for a 1st pose of CIP at the UAV
Patient whose anxiety measured by ENS Anxiety is at least 4/10 at entry
Patient having signed the Informed Consent

Key exclusion criteria (10 listed)

Patient not sufficiently fluent in the French language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material;
Patient with motion sickness;
Patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol;
Patient deprived of liberty or placed under guardianship or curators;
Pregnant or breastfeeding women;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual realityWhen the patient is ready to have the CIP procedure the tablet will be presented to him so that he can view and choose the immersive film that suits him best. Before fitting the virtual reality helmet and the start of the film, the patient's anxiety will be evaluated by ENS on a scale of 0 to 10 . The patient's anxiety will also be evaluated at the end of the procedure. The patient will be contacted by telephone by an investigator between D+1 and D+5 in order to reassess and remotely from the pose, his memorization of the gesture and to look for adverse events.	Device	CIP procedure under virtual reality

Primary outcome

Description of Patient's anxiety through his participation
Time frame: through study completion, an average of 5 days
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Evolution of Patient's anxiety during the procedure
Time frame: Day 0
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10

9 secondary outcomes

Effects of virtual reality on the pain perceived by the patient;
Time frame: Day 0 (after placing the port)
Effects of virtual reality on Pulse
Time frame: Day 0 (before, during and after placing the port)
Effects of virtual reality on Blood Pressure
Time frame: Day 0 (before, during and after placing the port)
Effects of virtual reality on memorization of the gesture
Time frame: Day 0 (after placing the port) and through study completion between D+1 and D+5
Effects of virtual reality on the perception of time
Time frame: Day 0 (after placing the port)
Effects of virtual reality on satisfaction and comfort during installation
Time frame: Day 0 (after placing the port)
Effects of virtual reality on the caregiver's perception of the ease of the gesture
Time frame: Day 0 (after placing the port)
Effects of virtual reality on caregiver satisfaction
Time frame: Day 0 (after placing the port)
Effects of virtual reality on the duration of the intervention
Time frame: Day 0 (after placing the port)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annie de FILIPPIS principal investigator

HCL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Anxiety and CIP, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of Patient's anxiety through his participation (time frame: through study completion, an average of 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05527379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.