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Completed

NCT Number: NCT03849976

Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille Catholic Hospitals

Lomme, Nord, 59462, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Therapeutic communication

Behavioral

Patients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication

Primary outcomes

  1. Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A

    Time frame: Day one (before intervention)

    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.

  2. Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: Day one (before intervention)

    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.

Secondary outcomes

  1. Evaluation of the experience of general anesthesia (EVAN-G) scale

    Time frame: In average one day (at hospital discharge)

    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.

  2. Likert scale

    Time frame: Day one (at the end of the intervention)

    Patient cooperation: evaluated by the nurse anesthesiologist with a Likert scale rated from 1 (no cooperation) to 5 (excellent cooperation).

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • University Hospital, Lille

Registry information

Official study title

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

Acronym: STRESSCOM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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