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Clinical Trials/NCT04706728
NCT04706728CompletedNot Applicable

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

Aalborg University2 sites in 1 country24 target enrollmentStarted: May 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
2
Primary Endpoint
State-Trait Anxiety Inventory (STAI-Y1)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • State-Trait Anxiety Inventory (STAI-Y1)(First four weeks of treatment.)

Investigators

Sponsor
Aalborg University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lars Rye Bertelsen

External Lecturer

Aalborg University

Study Sites (2)

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