Impact of Modern Art Therapy on Patients' Anxiety and Pain During the Waiting Time in an Emergency Department

NCT04997434 | Completed DMC

• 1 other identifier: 2021-01344
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Acute; Pain, Acute

Outcome Measures

Primary Outcomes (5)

• Anxiety self-assessment

  The primary outcomes of this study will be patients' self-assessment of their anxiety status using a visual analog scale and a validated questionnaire This measurement will be taken before and after an art therapy session during their waiting time in the emergency department.

  Up to 4 hours (from admission in the departement to end of session)

• Anxiety self-assessment

  The primary outcomes of this study will be patients' self-assessment of their anxiety status using the State-Trait Anxiety Inventory. This measurement will be taken before and after an art therapy session during their waiting time in the emergency department.

  Up to 4 hours (from admission in the departement to end of session)

• Pain self- assessment

  The primary outcomes of this study will be patients' self-assessment of their pain intensity using a visual analog scale. This measurement will be taken before and after an art therapy session during their waiting time in the emergency department.

  Up to 4 hours (from admission in the departement to end of session)

• Anxiety assessment

  The art therapist will also assess the patient's anxiety during the session using items that allow the recording of observable phenomena on a scale from 1 to 5, 1 beeing the worse outcome, 5 the best.

  20 minutes (during the session)

• Pain assessment

  The art therapist will also assess the patient's pain during the session using items that allow the recording of observable phenomena on a scale from 1 to 5, 1 beeing the worse outcome, 5 the best.

  20 minutes (during the session)

Secondary Outcomes (6)

• Pleasure self-assessment

  1 minute (end of session)

• Feeling towards the passage in the emergency department

  1 minute (end of session)

• Quality of realization self-assessment

  1 minute (end of session)

• Aesthetic pleasure self-assessment

  1 min (end of session)

• Pleasure towards the activity self-self assessment

  1 min (end of session)

Study Arms (2)

Intervention

EXPERIMENTAL

After 5-10 minute interview with the patient to define his or her tastes and contraindications to certain techniques. The patient will have 15 to 20 minutes to carry out an artistic activity, accompanied by the art therapist according to his/her needs. During the activity, verbal exchanges will continue. After 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.

Behavioral: Art-therapy in the emergency department

Control

NO INTERVENTION

The questionnaires and VAS will be offered to the control group at the beginning of the wait, then after 30 minutes of waiting under usual conditions.

Interventions

Art-therapy in the emergency department BEHAVIORAL

The intervention will begin with a 5-10 minute interview with the patient to define his or her tastes and contraindications to certain techniques. 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. At the end of the interview, modern art therapy will be presented to the patient and several artistic activities will be proposed (origami, drawing, creative writing). 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. 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivier Hugli: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, promoter

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 9, 2021
• Study Start: August 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)