AnxietyRELACSNCT04796389
Music for Anxiety in Critically Ill Patients
A study testing Music in people with Anxiety, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial summary
Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesNetherlands
- Study dates
- 24 Aug 2020to 1 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice).
- Expected ICU stay upon randomisation of at least another 48 hours.
- Written informed consent acquired from the patient or legal representative.
Who cannot join
- Patients with severe hearing impairment, defined as no verbal communication possible.
- Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included).
- Insufficient knowledge of the Dutch or English language for informed consent.
- Participation in another study that may possibly intervene with the primary outcome measure
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Erasmus MC
Rotterdam, South Holland, 3015 GD
Ikazia
Rotterdam, South Holland, 3083 AN
HagaZiekenhuis
The Hague, South Holland, 2545 AA
About this study
Official title: Result of a Music Intervention on Anxiety in Critically Ill Patients
Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients.
Objective: The primary objective is to assess the effect of music intervention on the level of anxiety.
Read more
Study design: A randomized controlled trial. Study population: Adult patients admitted to the intensive care unit, with whom communication is possible (Richmond Agitation Sedation Scale of -2 or higher).
Intervention (if applicable): The music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. Chosen music will be based on the preference of the patient. The control group will receive standard of care during the entire study.
Main study parameters/endpoints: The primary outcome is the effect of music on the Visual Analogue Scale for anxiety (VAS-A). Secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and ICU memory and experience.
- Conditions
- Anxiety
- Being tested
- Music
- Keywords
- music, anxiety, intensive care unit, critically ill
- Medical subject headings
- Anxiety Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Preferred music of the participant administered using headphones.
| Study group | Role | What they receive |
|---|---|---|
| Recorded music | Experimental | Recorded music intervention Receives: Other: Music |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (VAS-A)
Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means a worse outcome.
Measured: 1.5 year
Secondary outcomes (10)
Anxiety (STAI-6)
Measured using the 6-item State- Trait Anxiety Inventory (STAI-6), on a scale of 20 to 80, in which a higher score means a worse outcome.
Measured: 1.5 year
Sleep quality
Measured using a 7-item questionnaire, on a scale of 1 to 7, in which a lower score means a worse outcome.
Measured: 1.5 year
Delirium
Measured with the Intensive Care Delirium Screening Checklist (ICDSC), on a scale of 0 to 8, in which a score of 4 or higher indicates delirium.
Measured: 1 year
Sedative and opioid medication requirement
Including remifentanyl, propofol, benzodiazepines, dexmedetomidine, clonidine, paracetamol, sufentanyl, fentanyl, morphine, ketamine, epidural analgesia, haloperidol, and other benzodiazepines, atypical anxiolytics and antipsychotics.
Measured: 1.5 year
ICU memory and experience
Assessed by the ICU memory tool (ICU-MT), difference is assessed per item.
Measured: 1.5 year
Agitation and sedation level
Assessed using the Richmond- Agitation- Sedation Scale (RASS), on a scale of -5 to +4, negative scores indicate level of sedation (a more negative score indicates deeper sedation) and positive scores indicate levels of agitation (the higher the score the more agitated the patient).
Measured: 1.5 year
Complications
Complications related to agitation, defined as removal of lines and tube by the patient.
Measured: 1.5 year
Level of Pain
Measured using the Critical-Care Pain Observation (CPOT), on a scale of 0 to 8, in mechanically ventilated patients, or the NRS/VAS, on a scale of 0 to 10, for pain in non-ventilated and alert/oriented.
Measured: 1.5 year
Heart Rate (HR)
Heart Rate at the time of anxiety assessment in beats per minute.
Measured: 1.5 year
Mean Arterial Pressure (MAP)
Mean Arterial Pressure at the time of anxiety assessment in mmHg.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start24 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu van der Jagt, Erasmus Medical Center
- Investigators
- Mathieu Dr. M. van der Jagt, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796389
- Sponsor's protocol ID
- MEC-2020-0212
- Acronym
- RELACS
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kakar E, Ottens T, Stads S, Wesselius S, Gommers DAMPJ, Jeekel J, van der Jagt M. Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial. J Intensive Care. 2023 Aug 17;11(1):36. doi: 10.1186/s40560-023-00684-1.
PubMed 37592358Kakar E, Van Mol M, Jeekel J, Gommers D, van der Jagt M. Study protocol for a multicentre randomised controlled trial studying the effect of a music intervention on anxiety in adult critically ill patients (The RELACS trial). BMJ Open. 2021 Oct 12;11(10):e051473. doi: 10.1136/bmjopen-2021-051473.
PubMed 34642197
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Result of a Music Intervention on Anxiety in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04796389
- Acronym / sponsor ID
- RELACS / MEC-2020-0212
- Conditions
- Anxiety
- Keywords
- music, anxiety, intensive care unit, critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Mar 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.
Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients.
Objective: The primary objective is to assess the effect of music intervention on the level of anxiety.
Study design: A randomized controlled trial. Study population: Adult patients admitted to the intensive care unit, with whom communication is possible (Richmond Agitation Sedation Scale of -2 or higher).
Intervention (if applicable): The music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. Chosen music will be based on the preference of the patient. The control group will receive standard of care during the entire study.
Main study parameters/endpoints: The primary outcome is the effect of music on the Visual Analogue Scale for anxiety (VAS-A). Secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and ICU memory and experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Recorded music | Experimental | Other: MusicRecorded music intervention |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice).
- Expected ICU stay upon randomisation of at least another 48 hours.
- Written informed consent acquired from the patient or legal representative.
Key exclusion criteria (4 listed)
- Patients with severe hearing impairment, defined as no verbal communication possible.
- Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included).
- Insufficient knowledge of the Dutch or English language for informed consent.
- Participation in another study that may possibly intervene with the primary outcome measure
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 |
|---|---|---|
| MusicPreferred music of the participant administered using headphones. | Other | Recorded music |
Primary outcome
Anxiety (VAS-A)
Time frame: 1.5 year
Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means a worse outcome.
10 secondary outcomes
Anxiety (STAI-6)
Time frame: 1.5 year
Sleep quality
Time frame: 1.5 year
Delirium
Time frame: 1 year
Sedative and opioid medication requirement
Time frame: 1.5 year
ICU memory and experience
Time frame: 1.5 year
Agitation and sedation level
Time frame: 1.5 year
Complications
Time frame: 1.5 year
Level of Pain
Time frame: 1.5 year
Heart Rate (HR)
Time frame: 1.5 year
Mean Arterial Pressure (MAP)
Time frame: 1.5 year
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 13 Apr 2022.
- Derived from this study: PubMed 37592358Kakar E, Ottens T, Stads S, Wesselius S, Gommers DAMPJ, Jeekel J, van der Jagt M. Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial. J Intensive Care. 2023 Aug 17;11(1):36. doi: 10.1186/s40560-023-00684-1.
- Derived from this study: PubMed 34642197Kakar E, Van Mol M, Jeekel J, Gommers D, van der Jagt M. Study protocol for a multicentre randomised controlled trial studying the effect of a music intervention on anxiety in adult critically ill patients (The RELACS trial). BMJ Open. 2021 Oct 12;11(10):e051473. doi: 10.1136/bmjopen-2021-051473.
- Individual participant dataSharing planned: No
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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.
Mathieu Dr. M. van der Jagt, MD, PhD principal investigator
Erasmus Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety, run by Erasmus Medical Center at 3 sites in Netherlands.
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 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 (VAS-A) (time frame: 1.5 year). 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 NCT04796389, which also lists 2 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 13 Apr 2022.