Music Listening to Lower Anxiety During ECT Treatment.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Receptive Music Intervention for the Abatement of Anxiety for In-patients Diagnosed With Unipolar Depression Who Receive Standard ECT Treatment. (ECT: Electroconvulsive Therapy).

Conditions
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Anxiety State

Intervention / Treatment
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* Other: Listening to playlists with music prior to-, during and after the ECT procedure
* Other: Listening to playlists with music prior to-, during and after the ECT procedure
* Other: Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable in-patients of age at Aalborg University Hospital, Psychiatry - departments S7 S8, diagnosed with unipolar 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Playlists with Expert-Curated Music - four weeks<br>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). | Other: Listening to playlists with music prior to-, during and after the ECT procedure<br>* Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment.<br>|
| Active Comparator: Playlists with Expert-Curated Music - two weeks<br>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). | Other: Listening to playlists with music prior to-, during and after the ECT procedure<br>* Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.<br>|
| Placebo Comparator: Playlists with Nature Sounds<br>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). | Other: Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First week of ECT treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | First four weeks of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT, Anxiety State, Unipolar Depression, Expert-Curated Playlists