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Music Listening to Lower Anxiety During ECT Treatment. (MIECT)

Primary Purpose

Anxiety State

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Listening to playlists with music prior to-, during and after the ECT procedure
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
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety State focused on measuring Anxiety State, Unipolar Depression, Expert-Curated Playlists, ECT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital, PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Playlists with Expert-Curated Music - four weeks

Playlists with Expert-Curated Music - two weeks

Playlists with Nature Sounds

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 11, 2021
Last Updated
July 24, 2023
Sponsor
Aalborg University
Collaborators
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04706728
Brief Title
Music Listening to Lower Anxiety During ECT Treatment.
Acronym
MIECT
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
Keywords
Anxiety State, Unipolar Depression, Expert-Curated Playlists, ECT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Playlists with Expert-Curated Music - four weeks
Arm Type
Experimental
Arm Description
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).
Arm Title
Playlists with Expert-Curated Music - two weeks
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Playlists with Nature Sounds
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Listening to playlists with music prior to-, during and after the ECT procedure
Intervention Description
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
Intervention Name(s)
Listening to playlists with music prior to-, during and after the ECT procedure
Intervention Description
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
Intervention Name(s)
Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI-Y1)
Description
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.
Time Frame
First week of ECT treatment
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI-Y1)
Description
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).
Time Frame
First four weeks of treatment.
Other Pre-specified Outcome Measures:
Title
Anxiety Symptom Scale questionnaire (ASS).
Description
Defining the type of anxiety. Validated Anxiety Symptom Scale questionnaire (ASS), measured before 1st., 5th. and 9th. ECT procedure.
Time Frame
First four weeks of treatment.
Title
Non/validated questionnaire on patients experience of treatment quality.
Description
Self-made questionnaire on patients' experience of the treatment quality using playlists as an add-on to Treatment As Usual (TAU).
Time Frame
First four weeks of treatment.
Title
Semi-structured Follow-Up interview.
Description
Qualitative Follow-Up interview with two participants from each arm, approximately four weeks after their last ECT procedure.
Time Frame
One month after last ECT treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars R Bertelsen, PhD. student
Phone
+4520406025
Email
Larb@hum.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars R Bertelsen
Organizational Affiliation
Aalborg University, Doctoral Programme of Music Therapy.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Psychiatry
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars R Bertelsen, PhD Student
Phone
+4520406025
Email
larb@ikp.aau.dk
First Name & Middle Initial & Last Name & Degree
Lars R Bertelsen, PhD student

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Collected data is solely used for publishing PhD. articles.

Learn more about this trial

Music Listening to Lower Anxiety During ECT Treatment.

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