WoundPLAYNCT04426110
Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches
An observational study of Wound, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 10 Dec 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients visiting the emergency department for an acute skin wound with need for stitches.
Who may be able to join
- ≥ 18 years old
- Acute skin wound with need for stitches
- National health service coverage
- No opposition
Who cannot join
- Conditions interfering with consent or measures (no French-fluent, acute intoxication, neurologic or psychiatric pathology)
- Wound requiring surgical exploration
- Wound localized on or around an ear
- Major insufficiency of auditory function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches in Emergency Department
The aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.
Read the detailed description
Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits), inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being the most frequently used procedure.
Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with painful bedside procedures. Music is one of them, easy to use and without any side effects.
Music therapy has already been shown to reduce pain and anxiety levels in children during medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical or anaesthetic procedures.
Our objective is to apply this technic to adults in emergency departments during stitches wound management.
This is a study before / after the implementation of a music therapy protocol during stiches wound management. During the music period, the participant will choose and listen to one of the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a professional music therapist, via headphones. There will be no change in stitches wound management.
Pain and anxiety levels will be measured by visual analog scale before, during and after the stitches procedure.
- Conditions
- Wound
- Keywords
- Wound, Stitches, Pain, Anxiety, Music
- Medical subject headings
- Wounds and Injuries, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 "Control" | No Music. Wound stitches procedure conducted according to clinical practice. | |
| Period 2 "Music" | Music by headphones. Wound stitches procedure conducted according to clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal pain level
Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.
Measured: Day 0
Secondary outcomes (3)
Maximal anxiety level
Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.
Measured: Day 0
Final pain level
Final pain level measured by visual analog scale immediately after the procedure.
Measured: Day 0
Final anxiety level
Final anxiety level measured by visual analog scale immediately after the procedure.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Jun 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Clément THIEBAUD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426110
- Sponsor's protocol ID
- APHP200330
- Acronym
- PLAY
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2020
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
PubMed 16625614Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.
PubMed 18355741Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
PubMed 29665028
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches in Emergency Department
- ClinicalTrials.gov ID
- NCT04426110
- Acronym / sponsor ID
- PLAY / APHP200330
- Conditions
- Wound
- Keywords
- Wound, Stitches, Pain, Anxiety, Music
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 11 Jun 2020 (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 aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.
Detailed description
Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits), inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being the most frequently used procedure.
Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with painful bedside procedures. Music is one of them, easy to use and without any side effects.
Music therapy has already been shown to reduce pain and anxiety levels in children during medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical or anaesthetic procedures.
Our objective is to apply this technic to adults in emergency departments during stitches wound management.
This is a study before / after the implementation of a music therapy protocol during stiches wound management. During the music period, the participant will choose and listen to one of the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a professional music therapist, via headphones. There will be no change in stitches wound management.
Pain and anxiety levels will be measured by visual analog scale before, during and after the stitches procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 "Control" | – | –No Music. Wound stitches procedure conducted according to clinical practice. |
| Period 2 "Music" | – | –Music by headphones. Wound stitches procedure conducted according to clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients visiting the emergency department for an acute skin wound with need for stitches.
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Acute skin wound with need for stitches
- National health service coverage
- No opposition
Key exclusion criteria (4 listed)
- Conditions interfering with consent or measures (no French-fluent, acute intoxication, neurologic or psychiatric pathology)
- Wound requiring surgical exploration
- Wound localized on or around an ear
- Major insufficiency of auditory function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal pain level
Time frame: Day 0
Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.
3 secondary outcomes
Maximal anxiety level
Time frame: Day 0
Final pain level
Time frame: Day 0
Final anxiety level
Time frame: Day 0
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 18 Oct 2021.
- Background: PubMed 16625614Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
- Background: PubMed 18355741Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.
- Background: PubMed 29665028Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
- Individual participant dataSharing planned: Undecided
Related trials for Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Pierre-Clément THIEBAUD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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 18 Oct 2021. 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 France. 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?
Maximal pain level (time frame: Day 0). 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 NCT04426110, which also lists 3 linked publications.
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 18 Oct 2021.