Skip to main content
OpenTrials
Completed

NCT Number: NCT04706728

Music Listening to Lower Anxiety During ECT Treatment.

The purpose of this study is to assess whether music listening is helpful in lowering anxiety in patients about to start their ECT treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety State Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Psychiatry

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI-Y1)

    Time frame: First week of ECT treatment

    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 outcomes

  1. State-Trait Anxiety Inventory (STAI-Y1)

    Time frame: First four weeks of treatment.

    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).

Other outcomes

  1. Anxiety Symptom Scale questionnaire (ASS).

    Time frame: First four weeks of treatment.

    Defining the type of anxiety.

    Validated Anxiety Symptom Scale questionnaire (ASS), measured before 1st., 5th. and 9th. ECT procedure.

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

    Time frame: First four weeks of treatment.

    Self-made questionnaire on patients' experience of the treatment quality using playlists as an add-on to Treatment As Usual (TAU).

  3. Semi-structured Follow-Up interview.

    Time frame: One month after last ECT treatment

    Qualitative Follow-Up interview with two participants from each arm, approximately four weeks after their last ECT procedure.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

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

Acronym: MIECT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2021
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.