Anxiety AcuteNCT04997434
Impact of Modern Art Therapy on Patients' Anxiety and Pain During the Waiting Time in an Emergency Department
A study testing Art-therapy in the emergency department in people with Anxiety Acute and Pain, Acute, run by Olivier Hugli at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Acute, Pain, Acute
- What is being tested?
- Art-therapy in the emergency department
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
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.
Read the 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.
- Conditions
- Anxiety Acute, Pain, Acute
- Being tested
- Art-therapy in the emergency department
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art-therapy in the emergency departmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes (during the session)
Secondary outcomes (6)
Pleasure self-assessment
The secondary results of this study will be the patient's self-evaluation by visual analog scale of the pleasure felt during the activity. 1 will be the worse outcome, 10 the best.
Measured: 1 minute (end of session)
Feeling towards the passage in the emergency department
Questions will be asked to the patient regarding how he feels about his passage in the emergency department. The possible answers will be "poor", "fair", "good", "excellent". They will be converted in numbers from 1 to 4, 4 (excellent) being the best outcome.
Measured: 1 minute (end of session)
Quality of realization self-assessment
The secondary results of this study will be the patient's self-evaluation by visual analog scale of the quality of its realization.1 will be the worse outcome, 10 the best.
Measured: 1 minute (end of session)
Aesthetic pleasure self-assessment
The secondary results of this study will be the patient's self-evaluation by visual analog scale of the aesthetic pleasure felt in front of their realization. 1 will be the worse outcome, 10 the best.
Measured: 1 min (end of session)
Pleasure towards the activity self-self assessment
The secondary results of this study will be the patient's self-evaluation by visual analog scale of the pleasure expressed towards the activity. 1 will be the worse outcome, 10 the best.
Measured: 1 min (end of session)
Engagement of the patient in the activity assessment
The engagement of the patient in the activity during the session will also be evaluated by the art-therapist using items that allow the recording of observable phenomena on a scale from 1 to 5, 1 beeing the worse outcome, 5 the best.
Measured: 20 minutes (during the session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Aug 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier Hugli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier Hugli, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997434
- Sponsor's protocol ID
- 2021-01344
- Status last verified
- Dec 2022
- First submitted
- 19 Jul 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espejo T, Galvani O, Vaz C, Gerhard-Donnet H, Brochu-Vez MJ, Hugli O, Ageron FX. Effect of a brief art therapy intervention on anxiety and pain in emergency department patients: a randomized open-label trial. Int J Emerg Med. 2026 Mar 12;19(1):60. doi: 10.1186/s12245-026-01185-2.
PubMed 41820835
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Modern Art Therapy on Patients' Anxiety and Pain During the Waiting Time in an Emergency Department
- ClinicalTrials.gov ID
- NCT04997434
- Acronym / sponsor ID
- 2021-01344
- Conditions
- Anxiety Acute, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Olivier HugliUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Art-therapy in the emergency departmentAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art-therapy in the emergency departmentThe 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. | Behavioural | Intervention |
Primary outcome
Anxiety self-assessment
Time frame: Up to 4 hours (from admission in the departement to end of session)
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.
Anxiety self-assessment
Time frame: Up to 4 hours (from admission in the departement to end of session)
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.
Pain self- assessment
Time frame: Up to 4 hours (from admission in the departement to end of session)
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.
Anxiety assessment
Time frame: 20 minutes (during the session)
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.
Pain assessment
Time frame: 20 minutes (during the session)
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.
6 secondary outcomes
Pleasure self-assessment
Time frame: 1 minute (end of session)
Feeling towards the passage in the emergency department
Time frame: 1 minute (end of session)
Quality of realization self-assessment
Time frame: 1 minute (end of session)
Aesthetic pleasure self-assessment
Time frame: 1 min (end of session)
Pleasure towards the activity self-self assessment
Time frame: 1 min (end of session)
Engagement of the patient in the activity assessment
Time frame: 20 minutes (during the session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 41820835Espejo T, Galvani O, Vaz C, Gerhard-Donnet H, Brochu-Vez MJ, Hugli O, Ageron FX. Effect of a brief art therapy intervention on anxiety and pain in emergency department patients: a randomized open-label trial. Int J Emerg Med. 2026 Mar 12;19(1):60. doi: 10.1186/s12245-026-01185-2.
- Individual participant dataSharing planned: No
Related trials for Anxiety Acute
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
RecruitingPhase 3
Morphine or Ketamine for Analgesia
Abdominal Pain, Isolated Extremity Fracture
Enrolling by invitation
VR for Steroid Joint Injections - Feasibility
Acute Pain, Procedural Anxiety
RecruitingPhase 3
Artistic and Movement Activities to Reduce Anxiety in Children With Acute Lymphoblastic Leukemia.
Anxiety, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art-therapy in the emergency department in people with Anxiety Acute and Pain, Acute, run by Olivier Hugli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety self-assessment (time frame: Up to 4 hours (from admission in the departement to end of session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.