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Virtual RealityIVR-OrthoNCT05437796

Immersive Virtual Reality in Orthopedics

A study testing Hypnotic virtual reality support using hypnosis software Hypno-VR® and No Hypnotic virtual reality in people with Virtual Reality and Orthopedic, run by Centre Hospitalier de Montauban at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. The prosthetic knee surgeries are painful and anxiety-provoking acts. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Virtual Reality, Orthopedic
What is being tested?
Hypnotic virtual reality support using hypnosis software Hypno-VR® and No Hypnotic virtual reality
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteFrance
Study dates
1 Jan 2020to 2 Oct 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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eligible patients for prosthetic knee surgery under spinal anesthesia
  • Patient who has received appropriate information and has provided informed consent
  • Patient with French social security system

Who cannot join

  • Patient under general anaesthesia
  • Patients treated in conventional inpatient care or in the traditional ambulatory circuit
  • Patient under guardianship or trusteeship
  • Minor patient < 18 years of age
  • Patient who has not provided informed consent or who cannot submit to the study protocol
  • Patient suffering from cognitive disorders (ex: Alzheimer's disease)
  • Patients who are deaf or hearing-impaired or epilepsy
  • Infected patient or identified as carrier of an infectious agent

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Edmundo Pereira de Souza Neto

    Montauban, Tarn Et Garonne, 82000

    Edmundo P SOUZA NETO, PhD, 335.63.92.83.36, edmundo.pereira-de-souza@hotmail.fr

    Marlène P DUBOIS, 33 5 63 92 89 94, m.dubois@ch-montauban.fr

    Recruiting

Other trials in France

About this study

Official title: Using the Immersive Virtual Reality for the Management of Anxiety and Pain in Orthopedic Surgery

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Read the detailed description

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Despite a high level of approval of patients (according our satisfaction surveys) concerning hypnotic virtual reality, we want to evaluate our practice. Thus, in the future, we can invest in this type of material and make it available to a larger number of patients, but only if complementary care proves its effectiveness.

The purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.

Being tested
Hypnotic virtual reality support using hypnosis software Hypno-VR®, No Hypnotic virtual reality
Keywords
Anxiety, Immersive virtual reality, Orthopedics, Pain
Medical subject headings
Anxiety Disorders, Pain

What participants receive

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

  • Hypnotic virtual reality support using hypnosis software Hypno-VR®Device

    Also called Hypnotic virtual reality

    Hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)

  • No Hypnotic virtual realityDevice

    Group without Hypnotic virtual reality

Study groups in NCT05437796
Study groupRoleWhat they receive
Hypnotic virtual reality supportActive comparatorHypnotic virtual reality support using hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)
Receives: Device: Hypnotic virtual reality support using hypnosis software Hypno-VR®
Without hypnotic virtual reality supportSham comparatorNot described
Receives: Device: No Hypnotic virtual reality

What is being measured

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

  1. Measurement of state of anxiety Spielberger

    Questionnaire state of anxiety Spielberger: The Anxiety-State Scale assesses the feelings of apprehension, tension, nervousness and anxiety that the subject feels anxiety when the situation.

    The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores:

    Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety.

    Measured: 60 minutes

  2. Measurement of general anxiety Spielberger

    Questionnaire general anxiety Spielberger: This questionnaire assesses your anxiety in life in general, and refers to trait anxiety. It is a stable disposition of personality.

    The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores:

    Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety.

    Measured: 60 minutes

Secondary outcomes (1)
  1. Effectiveness of hypnotic virtual reality:

    The secondary objective of this research is to evaluate the effectiveness of hypnotic virtual reality:

    • On pain using evaluation visual analog scale (VAS) pain, graduated from 0 to 10, measured in the first 48 hours after surgery
    • On patient satisfaction using the Likert scale. The Likert scale is very popular and is often used in marketing research. It makes it possible to have nuances in the answers of respondents. Unlike scales dichotomous (yes / no), it makes it possible to have different degrees of judgment in analyzing the results. According to Likert, the most reliable measurement scales are those in seven ways:
    • Not at all satisfied
    • Unsatisfied
    • Somewhat dissatisfied
    • Neutral
    • Rather satisfied
    • Satisfied
    • Very satisfied

    Measured: 48 hours

Timeline

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

  1. First posted29 Jun 2022
  2. Study start1 Jan 2020
  3. Primary completion2 Oct 2023 (estimated)
  4. Study completion2 Oct 2023 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
The purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05437796
Sponsor's protocol ID
2020-A00005-34
Acronym
IVR-Ortho
Status last verified
Jul 2023
First submitted
19 Jun 2022
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Askay SW, Patterson DR, Sharar SR. VIRTUAL REALITY HYPNOSIS. Contemp Hypn. 2009 Mar;26(1):40-47. doi: 10.1002/ch.371.

    PubMed 20737029
  • Benhaiem JM, Attal N, Chauvin M, Brasseur L, Bouhassira D. Local and remote effects of hypnotic suggestions of analgesia. Pain. 2001 Jan;89(2-3):167-73. doi: 10.1016/s0304-3959(00)00359-6.

    PubMed 11166472
  • Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667.

    PubMed 18986237
  • Hoffman HG, Patterson DR, Soltani M, Teeley A, Miller W, Sharar SR. Virtual reality pain control during physical therapy range of motion exercises for a patient with multiple blunt force trauma injuries. Cyberpsychol Behav. 2009 Feb;12(1):47-9. doi: 10.1089/cpb.2008.0056.

    PubMed 19018695
  • Borteyrou X, Bruchon-Schweitzer M, Spielberger CD. [The French adaptation of the STAXI-2, C.D. Spielberger's State-trait anger expression inventory]. Encephale. 2008 Jun;34(3):249-55. doi: 10.1016/j.encep.2007.06.001. Epub 2007 Oct 10. French.

    PubMed 18558145
  • Spielberger CD, Auerbach SM, Wadsworth AP, Dunn TM, Taulbee ES. Emotional reactions to surgery. J Consult Clin Psychol. 1973 Feb;40(1):33-8. doi: 10.1037/h0033982. No abstract available.

    PubMed 4688678
  • Hodgues WF, Spielberger CD. An indicant of trait or state anxiety? J Consult Clin Psychol. 1969 Aug;33(4):430-4. doi: 10.1037/h0027813. No abstract available.

    PubMed 5810587
  • Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019. No abstract available.

    PubMed 30728719
  • Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.

    PubMed 31306747
  • Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.

    PubMed 31047650
  • Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.

    PubMed 31412029
  • Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, Asmundson GJG, Carlbring P, Powers MB. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019 Jan;61:27-36. doi: 10.1016/j.janxdis.2018.08.003. Epub 2018 Aug 10.

    PubMed 30287083
  • Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

    PubMed 30198451
  • Smith V, Warty RR, Sursas JA, Payne O, Nair A, Krishnan S, da Silva Costa F, Wallace EM, Vollenhoven B. The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review. J Med Internet Res. 2020 Nov 2;22(11):e17980. doi: 10.2196/17980.

    PubMed 33136055
  • Anderson PL, Molloy A. Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Curr Opin Psychol. 2020 Dec;36:153-157. doi: 10.1016/j.copsyc.2020.10.001. Epub 2020 Oct 15.

    PubMed 33176268

Questions about this trial

What is this clinical trial studying?

A study testing Hypnotic virtual reality support using hypnosis software Hypno-VR® and No Hypnotic virtual reality in people with Virtual Reality and Orthopedic, run by Centre Hospitalier de Montauban 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jul 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of state of anxiety Spielberger (time frame: 60 minutes). 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 NCT05437796, which also lists 17 linked publications.

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 25 Jul 2023.

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