NCT04238572

Brief Summary

This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia. Half of patients will receive an audiovisual distraction device while the other half not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 17, 2020

Last Update Submit

August 2, 2021

Conditions

Surgical Procedure, UnspecifiedAnalgesiaOutpatient

Keywords

Audiovisual distraction devicePeroperative opioid analgesiaAmbulatory careOutpatientAnalgesia nociception indexAnxietyRemifentanilRemifentanil added to local anesthesia

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Remifentanil dose

    μg/kg/min

    1 hour

Secondary Outcomes (6)

  • Preoperative pain measured with a numeric pain rating scale (NRS)

    1 hour

  • Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    1 hour

  • Preoperative anxiety measured by a visual analogue scale (VAS)

    1 hour

  • Per operative Analgesia nociception index (ANI) value

    1 hour

  • Post operative anxiety measured by a visual analogue scale (VAS)

    1 hour

  • +1 more secondary outcomes

Study Arms (2)

Audiovisual distraction device

EXPERIMENTAL

Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique

Device: Audiovisual distraction deviceDevice: Analgesia nociception index

Active comparator group

ACTIVE COMPARATOR

Analgesia nociception index monitoring, remifentanil added to local anesthesia technique

Device: Analgesia nociception index

Interventions

Audiovisual distraction deviceDEVICE

Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption

Audiovisual distraction device
Analgesia nociception indexDEVICE

ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement

Active comparator groupAudiovisual distraction device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient
  • Signed consent
  • Outpatient surgery eligibility
  • Patient covered by social security

You may not qualify if:

  • Unsigned consent
  • Study participation refusal
  • Deafness, blindness
  • Claustrophobia
  • ANI contraindication (atrial fibrillation, pace maker, severe autonomic system dysfunction)
  • Contraindication or impossibility to use the audiovisual distraction device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Calvados, 14000, France

Location

Related Publications (18)

  • Marsdin E, Noble JG, Reynard JM, Turney BW. Audiovisual distraction reduces pain perception during shockwave lithotripsy. J Endourol. 2012 May;26(5):531-4. doi: 10.1089/end.2011.0430. Epub 2012 Feb 8.

    PMID: 22098167BACKGROUND

  • Lee DW, Chan AC, Wong SK, Fung TM, Li AC, Chan SK, Mui LM, Ng EK, Chung SC. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial. Endoscopy. 2004 Mar;36(3):197-201. doi: 10.1055/s-2004-814247.

    PMID: 14986215BACKGROUND

  • Eccleston C, Crombez G. Pain demands attention: a cognitive-affective model of the interruptive function of pain. Psychol Bull. 1999 May;125(3):356-66. doi: 10.1037/0033-2909.125.3.356.

    PMID: 10349356BACKGROUND

  • Boselli E. Interest of Analgesia/Nociception Index (ANI) for monitoring the relative parasympathetic tone in anesthetized and awake patients. Douleurs (Paris) (2018)

    BACKGROUND

  • Boselli et al. Analgesia monitoring using Analgesia/Nociception Index: Results of clinical studies in awake and anesthetized patients. Le Praticien en anesthésie réanimation. 2015;19:78-86

    BACKGROUND

  • Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.

    PMID: 21095676BACKGROUND

  • Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8.

    PMID: 27170468BACKGROUND

  • Issa R, Julien M, Decary E, Verdonck O, Fortier LP, Drolet P, Richebe P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21.

    PMID: 28432612BACKGROUND

  • Boselli E, Musellec H, Martin L, Bernard F, Fusco N, Guillou N, Hugot P, Paqueron X, Yven T, Virot C. Effects of hypnosis on the relative parasympathetic tone assessed by ANI (Analgesia/Nociception Index) in healthy volunteers: a prospective observational study. J Clin Monit Comput. 2018 Jun;32(3):487-492. doi: 10.1007/s10877-017-0056-5. Epub 2017 Aug 20.

    PMID: 28825157BACKGROUND

  • Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.

    PMID: 22360936BACKGROUND

  • Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

    PMID: 24829420BACKGROUND

  • Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914.

    PMID: 26461074BACKGROUND

  • Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.

    PMID: 24099176BACKGROUND

  • Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.

    PMID: 23860442BACKGROUND

  • Abend R, Dan O, Maoz K, Raz S, Bar-Haim Y. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):447-53. doi: 10.1016/j.jbtep.2014.06.004. Epub 2014 Jun 18.

    PMID: 24978117BACKGROUND

  • Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.

    PMID: 1071419BACKGROUND

  • Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.

    PMID: 10702461BACKGROUND

  • Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. doi: 10.1207/s15324796abm3003_11.

    PMID: 16336078RESULT

MeSH Terms

Conditions

AgnosiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Clément Buléon, MD

    Caen UH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 200 patients will be randomized. 100 patients operated on in vitro fertilization (50 patients in intervention group, 50 patients in active comparator group) 100 patients operated on venous access port placement (50 patients in intervention group, 50 patients in active comparator group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

February 19, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)