Music Listening to Lower Anxiety During ECT Treatment.

Anxiety State Clinical Trial

— MIECT  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706728
• Other study ID #: VEK N-20200038
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Aalborg University
• Contact: Lars R Bertelsen, PhD. student
• Phone: +4520406025
• Email: Larb[@]hum.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

Intervention

Other:
• Listening to playlists with music prior to-, during and after the ECT procedure
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 music prior to-, during and after the ECT procedure
Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.
• Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure
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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Psychiatry	Aalborg	Region Nordjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety Symptom Scale questionnaire (ASS).	Defining the type of anxiety.; Validated Anxiety Symptom Scale questionnaire (ASS), measured before 1st., 5th. and 9th. ECT procedure.	First four weeks of treatment.
Other	Non/validated questionnaire on patients experience of treatment quality.	Self-made questionnaire on patients' experience of the treatment quality using playlists as an add-on to Treatment As Usual (TAU).	First four weeks of treatment.
Other	Semi-structured Follow-Up interview.	Qualitative Follow-Up interview with two participants from each arm, approximately four weeks after their last ECT procedure.	One month after last ECT treatment
Primary	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	State-Trait Anxiety Inventory (STAI-Y1)	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).	First four weeks of treatment.