Music Listening to Lower Anxiety During ECT Treatment.

NCT ID: NCT04706728

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-09-01

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.

Conditions

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Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

All participants are given a tablet with two playlists to choose from in each arm. Either two playlists with nature sounds, or two playlists with music.

Study Groups

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Playlists with Expert-Curated Music - four weeks

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).

Group Type EXPERIMENTAL

Listening to playlists with music prior to-, during and after the ECT procedure

Intervention Type OTHER

Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment.

Playlists with Expert-Curated Music - two weeks

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).

Group Type ACTIVE_COMPARATOR

Listening to playlists with music prior to-, during and after the ECT procedure

Intervention Type OTHER

Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.

Playlists with Nature Sounds

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).

Group Type PLACEBO_COMPARATOR

Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure

Intervention Type OTHER

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

Interventions

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Listening to playlists with music prior to-, during and after the ECT procedure

Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment.

Intervention Type OTHER

Listening to playlists with music prior to-, during and after the ECT procedure

Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.

Intervention Type OTHER

Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Lars Rye Bertelsen

External Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars R Bertelsen

Role: PRINCIPAL_INVESTIGATOR

Aalborg University, Doctoral Programme of Music Therapy.

Locations

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Aalborg University Hospital, Psychiatry

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VEK N-20200038

Identifier Type: -

Identifier Source: org_study_id

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