Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

Analgesia Clinical Trial

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Official title:

Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238572
• Other study ID #: 2019-A01243-54
• Status: Completed
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Early recovery for patients undergoing surgery is the key factor for an outpatient procedure.

The technique of adding remifentanil to a local anesthesia is used in 22% of the procedures realized in The CHU de Caen Outpatient unit. Decreasing opioid dose, whose side effects are numerous and widely described, as well as reducing anxiety are daily challenges to ensure comfort and successful care.

We propose a prospective, randomized, monocentric, open label study to evaluate the impact of the use of an audiovisual distraction device on the intraoperative consumption of opioids, on the patient's pain and peroperative anxiety.

ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement. We will analyze if audiovisual distraction can integrate existing techniques such as hypnosis.

Finally, we will also assess the medico-economic impact of this technique in order to establish a benefit / cost ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient

• Signed consent

• Outpatient surgery eligibility

• Patient covered by social security

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Analgesia
• Outpatient
• Surgical Procedure, Unspecified

Intervention

Device:
• Audiovisual distraction device
Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption
• Analgesia nociception index
ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (18)

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. — View Citation

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. — View Citation

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

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

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. — View Citation

Issa R, Julien M, Décary E, Verdonck O, Fortier LP, Drolet P, Richebé 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. — View Citation

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. — View Citation

Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloë 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Remifentanil dose	µg/kg/min	1 hour
Secondary	Preoperative pain measured with a numeric pain rating scale (NRS)	Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)	1 hour
Secondary	Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)	APAIS measures the need-for-information with 6 items. Each one is rated from 1 = Not at all to 5 = Extremely. There is positive and significant correlation between the ned-for-information and anxiety.	1 hour
Secondary	Preoperative anxiety measured by a visual analogue scale (VAS)	Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement "not anxious at all" and at the right hand (100mm) the statement "most anxious I can imagine"	1 hour
Secondary	Per operative Analgesia nociception index (ANI) value	From 0 = Predominant sympathetic tone, pain and anxiety to 100 = Predominant parasympathetic tone, good analgesia.; Negative linear Relationship between analgesia nociception index and pain scores	1 hour
Secondary	Post operative anxiety measured by a visual analogue scale (VAS)	Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement "not anxious at all" and at the right hand (100mm) the statement "most anxious I can imagine"	1 hour
Secondary	Postoperative pain measured with a numeric pain rating scale (NRS)	Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)	1 hour