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

"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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety State
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars R Bertelsen, PhD. student; Phone Number: +4520406025; Email: Larb@hum.aau.dk

Study Locations

• Denmark
  • Region Nordjylland
    • Aalborg, Region Nordjylland, Denmark, 9000
      • Recruiting
      • Aalborg University Hospital, Psychiatry
      • Principal Investigator: Lars R Bertelsen, PhD student
      • Contact: Lars R Bertelsen, PhD Student; Phone Number: +4520406025; Email: larb@ikp.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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 four weeks of their ECT treatment.; 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.
Active Comparator: 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).	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 four weeks of their ECT treatment.; 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.
Placebo Comparator: 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).	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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptom Scale questionnaire (ASS).	Defining the type of anxiety. Validated Anxiety Symptom Scale questionnaire (ASS), measured before 1st., 5th. and 9th. ECT procedure.	First four weeks of treatment.
Non/validated questionnaire on patients experience of treatment quality.	Self-made questionnaire on patients' experience of the treatment quality using playlists as an add-on to Treatment As Usual (TAU).	First four weeks of treatment.
Semi-structured Follow-Up interview.	Qualitative Follow-Up interview with two participants from each arm, approximately four weeks after their last ECT procedure.	One month after last ECT treatment

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Aalborg University Hospital
• Investigators: Principal Investigator: Lars R Bertelsen, Aalborg University, Doctoral Programme of Music Therapy.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Unipolar Depression; ECT; Anxiety State; Expert-Curated Playlists
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: VEK N-20200038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Collected data is solely used for publishing PhD. articles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No