Music Listening to Lower Anxiety During ECT Treatment.

NCT04706728 | Completed

• 1 other identifier: VEK N-20200038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State

Keywords

Anxiety State; Unipolar Depression; Expert-Curated Playlists; ECT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait Anxiety Inventory (STAI-Y1)

  First four weeks of treatment.

Other Outcomes (3)

• Anxiety Symptom Scale questionnaire (ASS).

  First four weeks of treatment.

• Non/validated questionnaire on patients experience of treatment quality.

  First four weeks of treatment.

• Semi-structured Follow-Up interview.

  One month after last ECT treatment

Study Arms (3)

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).

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).

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).

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

Interventions

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

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

Playlists with Nature Sounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Aalborg University Hospital, Psychiatry

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Rain; Lead

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Climatic Processes; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Atmosphere; Environment; Meteorological Concepts; Environment and Public Health; Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Lars R Bertelsen

  Aalborg University, Doctoral Programme of Music Therapy.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: External Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)