Clinical trial NCT03849976: Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety (STRESSCOM)
Official title: Evaluation of the Impact of the Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety in the Operating Room (STRESSCOM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Therapeutic communication
Anxiety
Endoscopic examination under general anesthesia
Operating room
Stretcher bearer
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2019-02-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients in ambulatory sector for endoscopic examination under general anesthesia.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A
timeFrame: Day one (before intervention)
measure: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: Day one (before intervention)
Secondary outcomes:
measure: Evaluation of the experience of general anesthesia (EVAN-G) scale
timeFrame: In average one day (at hospital discharge)
measure: Likert scale
timeFrame: Day one (at the end of the intervention)
Other outcomes:
Locations:
city: Lomme
country: France
facility: Lille Catholic Hospitals
state: Nord
Study officials:
affiliation: Lille Catholic University
name: Christophe Canevet
role: PRINCIPAL_INVESTIGATOR
References: