Clinical trial NCT04997434: Impact of Modern Art Therapy on Patients' Anxiety and Pain During the Waiting Time in an Emergency Department
Official title: Impact of Modern Art Therapy on Patients' Anxiety and Pain During the Waiting Time in an Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Acute
Pain, Acute
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to investigate whether, during a waiting period in an emergency department, the patient's participation in a modern art therapy session decreases the patient's level of anxiety and pain.

As a secondary objective, this study aims to explore whether participation in a modern art therapy session is perceived positively by the patient. This objective will be assessed by both patient self-report and art therapist heteroreport.

In this work, the investigators will therefore seek to demonstrate the potential positive impact of modern art therapy conducted during times of waiting for examination or results.

Detailed description: After reviewing the patients' medical records in the emergency department, and verifying the inclusion and exclusion criteria with the caregivers in charge of the case, the investigators will introduce themselves to the patients and offer them to participate in the study. The investigators will explain to the patients that their emergency department experience involves waiting time and that they are eligible for this study aimed at improving the well-being of emergency department patients during waiting time. Patients will be informed that the study aims to investigate the distracting effect of a modern art therapy session. If the patients ask about the modalities of the session, the investigators will answer that it will consist of an artistic production in accordance with their tastes and abilities, defined with the art therapist or a discussion with the research nurse about art therapy and its place in an emergency department and that they will be randomly assigned to one of the two groups.

At this stage, only oral consent will be obtained. After verifying that all inclusion criteria are met, that none of the exclusion criteria are applicable, and obtaining oral consent, each patient will be randomized 1:1 between the two study arms using the randomization module in the RedCap® software. The investigator in charge of data collection will collect some additional data in a standardized way by following the case report form.

The art therapist will then be able to intervene with the patient if the latter is part of the group participating in an art therapy session. A five- to ten-minute interview with the patient will allow the art therapist to get to know the patient and to learn more about his or her tastes and any contraindications the patient may have to certain techniques. This interview will begin with a discussion of the patient's general condition, both physical (pain, injury) and mental (mood), with the goal of assessing preserved and mobilizable abilities as well as affected and non-mobilizable mechanisms. The patient's tastes (artistic or other) will also be briefly questioned. Since the art-therapeutic intervention that will be proposed seeks to generate pleasant feelings, it will be important to rely on the patient's tastes. It is the patient's tastes and choices that will guide the decision of the dominant artistic elements, in order to maximize the pleasure taken in the activity and the distracting effect of the proposal. At the end of the interview, modern art therapy will be presented to the patient and several artistic activities will be proposed:

* Origami: paper folding activity requiring good fine motor skills, possible if the patient can fully use his/her hands. Requires a flat surface to put the paper on.
* Drawing: with dry techniques that will be disinfected after each use. It could be a drawing of invention, a comic strip to complete, an extension of a photo by a drawing...
* Writing: with markers or pens to allow for quick drying and avoid smearing. Creative writing games working on the imagination can be proposed.

All paper elements intended to be contemplated (models or works of art) will be wrapped in plastic to allow disinfection between each use.

Once the activity has been chosen, the patient will have 15 to 20 minutes to carry it out, accompanied by the art therapist according to his/her needs (explanations, gestural and technical support, partial or total realization by the art therapist under the patient's orders...). During the activity, verbal exchanges will continue. After the 15 to 20 minutes of the session, 5 minutes will be devoted to the patient's self-evaluation of the past moment, of his level of anxiety, of the intensity of his pain and of his feelings in relation to his passage in the Emergency Department and the art therapy session. The question will then be raised as to what will happen to the production, which will either be discarded or given to the patient to take with him/her.

The materials used for this study are common plastic arts materials (pencils, markers, paper) that are non-toxic and non-dirty. Reproductions of artworks in the form of postcards may also be shown to the patients.

For the control group without art therapy, the patient will be left in the usual waiting conditions for 20 to 30 minutes. After this waiting time, the patient will be asked to self-assess his or her level of anxiety, pain intensity and feelings about his or her visit to the emergency department.

Once all the data has been collected, a complete information sheet and a consent form will be given to the patient. Additional explanations can be given upon request. Patients will have a minimum of 15 minutes to sign the consent form.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patient whose management requires waiting for a procedure, an examination or results
* Patient whose pain is evaluated at least 3/10 by a VAS on arrival in the emergency room.

Exclusion Criteria:

* Clinically unstable patients (i.e., admitted to the intensive care unit or deemed unstable by the physician or nurse responsible for the patient)
* Patient incapable of judgement or with whom it is difficult to communicate
* Altered mental status (e.g. cognitive impairment, mental retardation, acute confusional state, acute psychosis)
* Intoxication
* Alcohol abuse
* Patient unable to communicate in French at a level sufficient to give informed consent and answer questions related to their anxiety and pain
* Patient unable to understand the use of VAS scales
* Patient incarcerated
* Patient transferred from another hospital
* Patient who has participated in this study at a previous visit
* Patient with chronic pain

Primary outcomes:
measure: Anxiety self-assessment
timeFrame: Up to 4 hours (from admission in the departement to end of session)
measure: Anxiety self-assessment
timeFrame: Up to 4 hours (from admission in the departement to end of session)
measure: Pain self- assessment
timeFrame: Up to 4 hours (from admission in the departement to end of session)
measure: Anxiety assessment
timeFrame: 20 minutes (during the session)
measure: Pain assessment
timeFrame: 20 minutes (during the session)
Secondary outcomes:
measure: Pleasure self-assessment
timeFrame: 1 minute (end of session)
measure: Feeling towards the passage in the emergency department
timeFrame: 1 minute (end of session)
measure: Quality of realization self-assessment
timeFrame: 1 minute (end of session)
measure: Aesthetic pleasure self-assessment
timeFrame: 1 min (end of session)
measure: Pleasure towards the activity self-self assessment
timeFrame: 1 min (end of session)
measure: Engagement of the patient in the activity assessment
timeFrame: 20 minutes (during the session)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
References: