Clinical trial NCT04706728: Music Listening to Lower Anxiety During ECT Treatment.
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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Keywords: Anxiety State
Unipolar Depression
Expert-Curated Playlists
ECT
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2021-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI-Y1)
timeFrame: First week of ECT treatment
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI-Y1)
timeFrame: First four weeks of treatment.
Other outcomes:
measure: Anxiety Symptom Scale questionnaire (ASS).
timeFrame: First four weeks of treatment.
measure: Non/validated questionnaire on patients experience of treatment quality.
timeFrame: First four weeks of treatment.
measure: Semi-structured Follow-Up interview.
timeFrame: One month after last ECT treatment
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Psychiatry
state: Region Nordjylland
Study officials:
affiliation: Aalborg University, Doctoral Programme of Music Therapy.
name: Lars R Bertelsen
role: PRINCIPAL_INVESTIGATOR
References: