The objective of the study is to assess the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is presence of postictal agitation as determined by the
Richmond Agitation-Sedation Scale (RASS).
Secondary outcome
The secondary outcomes are severity of PIA, duration of PIA, pretreatment
anxiety, music listening behavior, duration of recovery (time spent in the
recovery room), pre-, peri-, and post-treatment medication use, severity of
depression, and cognitive impairment, measured by the Montreal Cognitive
Assessment (MoCA) questionnaire.
Background summary
Postictal agitation (PIA) is a fairly common adverse effect after
electroconvulsive therapy (ECT) treatment that when present, predicts other
complications such as retrograde amnesia. Multiple studies have suggested that
a music intervention in the context of surgery significantly reduces
pre-operative anxiety, as well as the need for sedatives and analgesic
medication. Pretreatment anxiety is common for ECT patients and is a known
predictor of PIA. Currently there is no preventative treatment for PIA. Given
the beneficial effects of music demonstrated in similar hospital settings
combined with its easy implementation and lack of side effects, we hypothesize
that music listening can lower the incidence and severity of PIA among
patients undergoing ECT therapy, thereby also reducing post treatment cognitive
impairment.
Study objective
The objective of the study is to assess the effect of music on postictal
agitation when played peri-interventionally for patients undergoing
electroconvulsive therapy for severe depression.
Study design
Multi-center prospective randomized controlled trial.
Intervention
Recorded music, with headphones, for 30 minutes directly before ECT and 12
minutes directly after ECT.
Study burden and risks
Music as an intervention is not known to have a negative effect on subjects.
The volume of the music will not exceed 80 decibels. The burden includes the
electric stimuli. Negative consequences are minimized by taking safety
precautions. The burden will be to fill in questionnaires and to listen to
music. Participation in this study includes two extra outpatient visits of
approximately 20 minutes.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Patients undergoing ECT treatment for depression
2. Hypnotic agent used is etomidate
3. Adult patients (>=18 years)
4. Sufficient understanding of the Dutch language
5. Written informed consent by patient or legal representative
Exclusion criteria
1. Significant impaired hearing
2. Severe neurological condition
3. Patients receiving ECT for treatment of schizophrenic disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86074.078.24 |