CClinicalTrials.gg
Status unknownNCT04731792REVDOUUpdated Feb 1, 2021

Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

An interventional study of Virtual Reality in Anxiety, Stress and Pain, sponsored by Centre Chirurgical Marie Lannelongue. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Centre Chirurgical Marie Lannelongue · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.

The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.

Translated with www.DeepL.com/Translator (free version)

02

Conditions studied

  • Anxiety
  • Stress
  • Pain
  • Bronchial Fibroscopy
  • Pulmonary Transplantation

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03

In context

Anxiety Disorders

4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's planned enrollment of 152 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with a lung or cardio-pulmonary transplant
  • Adults (age > 18 years old)
  • Patient who give their informed consent for the protocol
  • Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality

Exclusion criteria

Exclusion Criteria:

  • children
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Virtual Reality group

    Other: Virtual Reality

  • No intervention
    control group

Interventions

  • OtherVirtual Reality

    a bronchial fibroscopy with a virtual reality helmet

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What researchers measure

Primary outcomes

  1. Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).

    Time frame: 1 day

Secondary outcomes

  1. Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Centre Chirurgical Marie Lannelongue
    Le Plessis Robinson, 92350, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04731792
Lead sponsor
Centre Chirurgical Marie Lannelongue
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Jan 14, 2021
Primary completion
Jan 14, 2024 (estimated)
Completion
Feb 14, 2024 (estimated)
Last update
Feb 1, 2021

Study contacts

Cécile DEGOULET
Contact
c.degoulet@ghpsj.fr
01 40 94 25 98

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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