Anxiety StateMIECTNCT04706728
Music Listening to Lower Anxiety During ECT Treatment.
A study testing Listening to playlists with music prior to-, during and after the ECT procedure and Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure in people with Anxiety State, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to assess whether music listening is helpful in lowering anxiety in patients about to start their ECT treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State
- What is being tested?
- Listening to playlists with music prior to-, during and after the ECT procedure and Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 1 Sep 2023
- 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
- Capable in-patients of age at Aalborg University Hospital, Psychiatry - departments S7
- S8, diagnosed with unipolar or bipolar depression, referred to ECT treatment.
- patients assessed to fit the study, by the head of departments S7 \& S8
- Voluntary participation in the study after written informed consent.
- Patients can withdraw their consent at any point during the treatment trajectory.
Who cannot join
- Patients not compliant with the study, as assessed by head of departments
- Non-capable patients
- Patients who withdraw their written informed consent
- Patients using hearing aid
- Patients with former ECT treatment experience
- Patients who receive acute ECT Treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital, Psychiatry
Aalborg, North Denmark, 9000
About this study
Official title: "Receptive Music Intervention for the Abatement of Anxiety for In-patients Diagnosed With Unipolar Depression Who Receive Standard ECT Treatment". (ECT: Electroconvulsive Therapy).
The purpose of this study is to assess whether music listening is helpful in lowering anxiety in patients about to start their ECT treatment.
Read the detailed description
In-patients at a psychiatric hospital referred to ECT treatment, is offered to participate in the study investigating whether listening to expert-curated playlists before-, during and after ECT treatment is helpful as a non-pharmacological intervention in lowering patients anxiety.
After written informed consent, participants will be randomised into two groups, one listening to playlists with music, one listening to sounds from nature (e.g. rain, ocean waves). Playlists will be administered by tablet+earphones in the waiting room, tablet+speaker in the room of procedure and tablet+bedside speaker in the recovery room.
- Conditions
- Anxiety State
- Being tested
- Listening to playlists with music prior to-, during and after the ECT procedure, Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure
- Keywords
- Anxiety State, Unipolar Depression, Expert-Curated Playlists, ECT
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to playlists with music prior to-, during and after the ECT procedureOther
Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment.
Listening to playlists with music prior to-, during and after the ECT procedureOther
Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.
Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedureOther
Patients choose between two expert-curated playlists with sounds from nature one day prior to ECT procedures for the first two weeks of their ECT treatment
| Study group | Role | What they receive |
|---|---|---|
| Playlists with Expert-Curated Music - four weeks | Experimental | Patients can choose from two expert-curated playlists with music, matching the trajectory of the ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for four weeks (the first eight ECT procedures). Receives: Other: Listening to playlists with music prior to-, during and after the ECT procedure |
| Playlists with Expert-Curated Music - two weeks | Active comparator | Patients can choose from two expert-curated playlists with music, matching the trajectory of the ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for two weeks (the first four ECT procedures). Receives: Other: Listening to playlists with music prior to-, during and after the ECT procedure |
| Playlists with Nature Sounds | Placebo comparator | Patients can choose from two expert-curated playlists with recorded sounds from nature (Rain, Waves) during ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for four weeks (the first eight ECT procedures). Receives: Other: Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI-Y1)
Measurement of patient anxiety before their first-, and before their second ECT procedure.
Patients report of anxiety before their ECT treatment and therefore their anxiety is measured in validated STAI-Y1 questionnaire the evening before the first and before the second ECT procedure.
Measured: First week of ECT treatment
Secondary outcomes (1)
State-Trait Anxiety Inventory (STAI-Y1)
Measurement of patient anxiety before their fifth.-, and before their ninth. ECT procedure.
Patients report of anxiety before their ECT treatment and therefore their anxiety is measured in validated STAI-Y1 questionnaire during their first 8 ECT treatments, to see differences in anxiety levels over time (if any).
Measured: First four weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 May 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- Model description
- Randomized Controlled Trial (RCT) with three arms, of which one is listening to playlists with sounds from nature for four weeks, one is listening to playlists with expert-curated music for four weeks, one is listening to playlists with expert-curated music for two weeks.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Lars Rye Bertelsen, Aalborg University
- Investigators
- Lars R Bertelsen, Principal investigator, Aalborg University, Doctoral Programme of Music Therapy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706728
- Sponsor's protocol ID
- VEK N-20200038
- Acronym
- MIECT
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2021
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Collected data is solely used for publishing PhD. articles.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Receptive Music Intervention for the Abatement of Anxiety for In-patients Diagnosed With Unipolar Depression Who Receive Standard ECT Treatment". (ECT: Electroconvulsive Therapy).
- ClinicalTrials.gov ID
- NCT04706728
- Acronym / sponsor ID
- MIECT / VEK N-20200038
- Conditions
- Anxiety State
- Keywords
- Anxiety State, Unipolar Depression, Expert-Curated Playlists, ECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 13 Jan 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 purpose of this study is to assess whether music listening is helpful in lowering anxiety in patients about to start their ECT treatment.
Detailed description
In-patients at a psychiatric hospital referred to ECT treatment, is offered to participate in the study investigating whether listening to expert-curated playlists before-, during and after ECT treatment is helpful as a non-pharmacological intervention in lowering patients anxiety.
After written informed consent, participants will be randomised into two groups, one listening to playlists with music, one listening to sounds from nature (e.g. rain, ocean waves). Playlists will be administered by tablet+earphones in the waiting room, tablet+speaker in the room of procedure and tablet+bedside speaker in the recovery room.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial (RCT) with three arms, of which one is listening to playlists with sounds from nature for four weeks, one is listening to playlists with expert-curated music for four weeks, one is listening to playlists with expert-curated music for two weeks.
| Arm | Type | Receives |
|---|---|---|
| Playlists with Expert-Curated Music - four weeks | Experimental | Other: Listening to playlists with music prior to-, during and after the ECT procedurePatients can choose from two expert-curated playlists with music, matching the trajectory of the ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for four weeks (the first eight ECT procedures). |
| Playlists with Expert-Curated Music - two weeks | Active comparator | Other: Listening to playlists with music prior to-, during and after the ECT procedurePatients can choose from two expert-curated playlists with music, matching the trajectory of the ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for two weeks (the first four ECT procedures). |
| Playlists with Nature Sounds | Placebo comparator | Other: Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedurePatients can choose from two expert-curated playlists with recorded sounds from nature (Rain, Waves) during ECT treatment (immediately before-, during and after the procedure). Playlists are available to the patients for four weeks (the first eight ECT procedures). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable in-patients of age at Aalborg University Hospital, Psychiatry - departments S7
- patients assessed to fit the study, by the head of departments S7 \& S8
- Voluntary participation in the study after written informed consent.
- Patients can withdraw their consent at any point during the treatment trajectory.
Key exclusion criteria (6 listed)
- Patients not compliant with the study, as assessed by head of departments
- Non-capable patients
- Patients who withdraw their written informed consent
- Patients using hearing aid
- Patients with former ECT treatment experience
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 |
|---|---|---|
| Listening to playlists with music prior to-, during and after the ECT procedurePatients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment. | Other | Playlists with Expert-Curated Music - four weeks |
| Listening to playlists with music prior to-, during and after the ECT procedurePatients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment. | Other | Playlists with Expert-Curated Music - two weeks |
| Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedurePatients choose between two expert-curated playlists with sounds from nature one day prior to ECT procedures for the first two weeks of their ECT treatment | Other | Playlists with Nature Sounds |
Primary outcome
State-Trait Anxiety Inventory (STAI-Y1)
Time frame: First week of ECT treatment
Measurement of patient anxiety before their first-, and before their second ECT procedure. Patients report of anxiety before their ECT treatment and therefore their anxiety is measured in validated STAI-Y1 questionnaire the evening before the first and before the second ECT procedure.
1 secondary outcome
State-Trait Anxiety Inventory (STAI-Y1)
Time frame: First four weeks of treatment.
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 4 Sep 2024.
- Individual participant dataSharing planned: No. Collected data is solely used for publishing PhD. articles.
Related trials for Anxiety State
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Lars R Bertelsen principal investigator
Aalborg University, Doctoral Programme of Music Therapy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to playlists with music prior to-, during and after the ECT procedure and Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure in people with Anxiety State, run by Aalborg University at 1 site in Denmark.
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 5 inclusion and 6 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 4 Sep 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
State-Trait Anxiety Inventory (STAI-Y1) (time frame: First week of ECT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.