Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety (STRESSCOM) (STRESSCOM)

Evaluation of the Impact of the Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety in the Operating Room (STRESSCOM)

Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. However, its effect is now controversial and non-drug techniques have been also studied.

The therapeutic communication aims to provide analgesia or anxiolysis to enhance the patient's well-being and to separate the patient from the surrounding reality through the suggestion of positive images with a chosen verbal and nonverbal approach. This prospective, monocentric, comparative, double-blind study aims to evaluate the impact of the training of stretcher-bearers in therapeutic communication on the anxiety of patients who go to the operating room for an endoscopic examination under general anaesthesia.Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Therapeutic communication

Detailed Description

Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a normal reaction of adaptation and defense face to a situation lived as hostile. It is a frequent perioperative manifestation. Patients who need an intervention are indeed 20% more anxious than the general population. The occurrence of this anxiety can have consequences for perioperative medical care influencing morbidity and mortality.

Pharmacological premedication initially prescribed in the 19th century to limit the adverse effects of general anesthesia is currently used to fight perioperative anxiety. However, its effects are now considered as controversial.

and non-drug techniques have been studied. They have the advantage of being inexpensive and causing little or no adverse effects.

Therapeutic communication can be defined as a relational technique that seeks to separate the patient from the surrounding reality to provide analgesia or anxiolysis through the suggestion of positive images with a chosen verbal and nonverbal approach.

The knowledge of communication techniques resulting from hypnosis by the healthcare team could therefore optimize patient medical care in terms of analgesia and the management of perioperative anxiety. Therapeutic communication training in the operating room is short and accessible to all members of the team regardless of their rank. This is a training provided internally by a certified practitioner in therapeutic hypnosis, aiming to give to the professionals knowledge to optimize the patient support. At the hospital (Groupement des Hôpitaux de l'Institut Catholique de Lille), several stretcher bearers have been trained in therapeutic communication and are already applying it routinely.

No study has yet investigated the impact of the use of therapeutic communication in the operating room to control the level of anxiety of patients.

This study is prospective, monocentric, comparative, double blind. Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• France
  • Nord
    • Lomme, Nord, France, 59462
      • Lille Catholic Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients in ambulatory sector for endoscopic examination under general anesthesia.

Description

Inclusion Criteria:

• Major patients
• Hospitalized in the ambulatory sector for endoscopic examination under general anesthesia (fibroscopy/colonoscopy/others)
• Able to answer anxiety questionnaires
• Able to walk to the operating room according to the usual practice (no motor disorder)
• Not presenting a psychiatric or cognitive disorder, or a non-paired hearing disorder that may interfere with therapeutic communication
• Being informed and not being opposed

Exclusion Criteria:

• Refusal to participate in the study
• Patients under guardianship
• Patient who received premedication before going down to the operating room (benzodiazepines, gabapentin, antihistamines)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Patients accompanied to the operating room by a stretcher bearer trained in therapeutic communication	Behavioral: Therapeutic communication; Patients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication
Control group; Patients accompanied to the operating room by a stretcher bearer not trained in therapeutic communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A	This scale is composed of 20 propositions to know how the subject feels. Each item has a score from 1 to 4 (4 being the highest degree of anxiety). The score therefore varies from 20 to 80.	Day one (before intervention)
Amsterdam Preoperative Anxiety and Information Scale (APAIS)	The APAIS questionnaire includes 6 questions, 2 of which evaluate the patient's anxiety about anesthesia, 2 questions estimate the anxiety about the procedure, the last 2 questions evaluate the patient's need for information about anesthesia and the procedure. Each question is rated from 1 to 5, the scale allows to calculate 4 scores (anesthetic anxiety/intervention anxiety/global and information request score). Subjects are considered anxious when they have a score higher than 11 for these 4 items.	Day one (before intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the experience of general anesthesia (EVAN-G) scale	EVAN-G questionnaire includes 26 questions. Results are grouped together to define 6 "dimensions": Focus of attention, Information, Privacy, Pain, Discomfort and Waiting Times. From these scores, an overall satisfaction score is calculated (average of all scores). For each of the scores: the higher the score, the higher the satisfaction.	In average one day (at hospital discharge)
Likert scale	Patient cooperation: evaluated by the nurse anesthesiologist with a Likert scale rated from 1 (no cooperation) to 5 (excellent cooperation).	Day one (at the end of the intervention)

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: University Hospital, Lille
• Investigators: Principal Investigator: Christophe Canevet, Lille Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): December 17, 2019
• Study Completion (ACTUAL): December 17, 2019

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Operating room; Therapeutic communication; Endoscopic examination under general anesthesia; Stretcher bearer
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RC-P0075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No