Music Listening to Lower Anxiety During ECT Treatment.

Not Applicable

Recruiting

• Conditions: Anxiety State
• Interventions: 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

• Registration Number: NCT04706728
• Lead Sponsor: Aalborg University

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 Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-05-01
• Status Verified: 2022-08
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Playlists with Expert-Curated Music - two weeks	Listening to playlists with music prior to-, during and after the ECT procedure	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).
Playlists with Expert-Curated Music - four weeks	Listening to playlists with music prior to-, during and after the ECT procedure	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).
Playlists with Nature Sounds	Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure	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).

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI-Y1)	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 Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI-Y1)	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).

Trial Locations

Locations (1)

Aalborg University Hospital, Psychiatry; 🇩🇰 Aalborg, Region Nordjylland, Denmark