Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05437796
Other study ID # 2020-A00005-34
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date October 2, 2023

Study information

Verified date July 2023
Source Centre Hospitalier de Montauban
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 2, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hypnotic virtual reality support using hypnosis software Hypno-VR®
Hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)
No Hypnotic virtual reality
Group without Hypnotic virtual reality

Locations

Country Name City State
France Edmundo Pereira de Souza Neto Montauban Tarn Et Garonne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Montauban

Country where clinical trial is conducted

France, 

References & Publications (17)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093. — View Citation

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. — View Citation

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. — View Citation

Negrillo-Cardenas J, Jimenez-Perez JR, Feito FR. The role of virtual and augmented reality in orthopedic trauma surgery: From diagnosis to rehabilitation. Comput Methods Programs Biomed. 2020 Jul;191:105407. doi: 10.1016/j.cmpb.2020.105407. Epub 2020 Feb 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
60 minutes
Primary 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.
60 minutes
Secondary 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
48 hours
See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Recruiting NCT05528497 - Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Completed NCT04091659 - Use of Virtual Reality for Overdose Management Educational Trainings N/A
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Not yet recruiting NCT05982457 - The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching N/A
Completed NCT06112600 - The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination N/A
Active, not recruiting NCT04532866 - Brain Changes in Response to Long-Duration Isolation and Confinement N/A
Completed NCT05604924 - Virtual Reality Training Simulator for Cesarean Section N/A
Recruiting NCT04736888 - Effectiveness of Extended Reality CPR Training Methods N/A
Not yet recruiting NCT05941390 - Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures N/A
Completed NCT05961033 - The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Recruiting NCT04630184 - A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity N/A
Terminated NCT03665233 - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty N/A
Recruiting NCT03698526 - Virtual Reality for Symptoms Control in Palliative Care N/A
Suspended NCT03715400 - Mobile Virtual Positive Experiences for Anhedonia N/A
Completed NCT03208400 - Virtual Reality Exposure in Spider Phobia N/A
Completed NCT05078762 - Immersive Virtual Reality in Simulation-based Bronchoscopy Training N/A