Clinical trial NCT04358094: Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)
Official title: Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Site Pain
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.

Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.

The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.

The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.

The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.


Eligibility criteria: Inclusion Criteria:

* Digestive endoscopy procedure under general anesthesia in one of the participating centers
* Patient speaking and understanding French
* Patient affiliated or entitled to a social security scheme
* Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection

Exclusion Criteria:

* Patient with deafness
* Patient with cognitive impairment
* Pregnant and / or breastfeeding patient
* Patient with dissociative disorders (contraindication to hypnosis)
* Patient suffering from a pathology which can cause chronic pain
* Patient receiving analgesia or anxiety drug
* Patient under justice, curatorship or tutorship
* Patient deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Analgesia assessment by digital pain scale
timeFrame: immediately after applying the peripherical veinous catheter dressing
Secondary outcomes:
measure: Level of anxiety by numerical scale
timeFrame: before randomization and immediately after peripherical veinous catheter set up
measure: patient satisfaction within the perioperative period (EVAN G questionnaire)
timeFrame: between 4 and 48 hours after the procedure
measure: Heart rate
timeFrame: during the procedure
measure: Nurse anesthetist feeling about using the script after each use by digital scale
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
affiliation: Central Hospital, Nancy, France
name: Hervé Bouaziz, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.
citation: Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.
citation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
citation: Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.