An interventional study of Weighted blanket and Usual Care Group in Post-ect Agitation and Post-ictal Agitation, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn if weighted blanket use before and after electroconvulsant therapy (ECT) works to reduce pre-ECT anxiety and post-ECT agitation.
The main questions it aims to answer are:
Does weighted blanket use before and after ECT reduce patient reported anxiety before ECT? Does weighted blanket use before and after ECT reduce post-ECT agitation following ECT?
Participants will:
Use either a weighted blanket or a non-weighted blanket before and after ECT. Report their anxiety before ECT Be observed for post-ECT agitation as they awaken from anesthesia after ECT.
Study design: Pilot Crossover design RCT
Method of enrollment: Informed written consent from either the patient or their LAR will be obtained by the study coordinator(s) prior to enrollment.
Subjects and recruitment methods: Enrolled patients will be computer randomized in 1:1 ratio to either receive the weighted blanket with their first observed ECT (Sequence A) or usual care first (Sequence B). If the patient undergoes multiple observed ECTs during the study period, then patients will alternate between receiving the intervention and receiving usual care.
Primary outcome measures:
Post-ictal agitation (PIA) score (1 = calm or asleep, 2 =rest less but calmed down when talked to, 3=restless and required a nurse to stand next to the bed, 4=one or more nurses were required to physically hold down the patient).
Secondary outcome measures:
23 studies on the registry are indexed under Epilepsy, Rolandic; 3 are open to participants now.
This study's planned enrollment of 200 is above the median of 44 across 13 interventional studies indexed under Epilepsy, Rolandic.
Browse Epilepsy, Rolandic studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Exclusion Criteria:
Intervention - 1. Patient (or their LAR) will be informed of the study and asked to sign a consent form if willing to participate. 2. Patient will arrive to the pre-ECT area and complete a visual analog anxiety scale prior to weighted blanket placement (10 lbs for patients weighing \>100 lbs, 5 lb blanket for those weighing less than 100 lbs) 3. Patient will wear the weighted blanket for at least 15 minutes in the pre-ECT area 4. Patient will complete a visual analog anxiety scale upon removal of the weighted blanket prior to ECT 5. Patient will complete a brief survey regarding their experience of the weighted blanket as the weighted blanket is removed in preparation for ECT 6. In the PACU area, weighted blanket will again be placed as long as this is felt to be safe from an RN perspective. 7. PACU RN will rate degree of post-ECT agitation (if any) and report whether PRN medications for agitation were required
Other: Weighted blanket
Usual care - 1. Patient (or their LAR) will be informed of the study and asked to sign a consent form if willing to participate. 2. Patient will not receive the weighted blanket. They will be offered either room temperature non-weighted blanket or warm non-weighted blanket as per usual care. 3. Patient will complete a visual analog anxiety scale before and after non-weighted blanket use. 4. PACU RN will rate degree of post-ECT agitation (if any) and report whether PRN medications for agitation were required
Other: Usual Care Group
Weighted blankets, a form of deep pressure stimulation, have been shown to be an effective non-pharmacologic means of improving anxiety in psychiatric, pediatric, geriatric, and oncologic populations.
Patients receiving usual care will receive non-weighted blankets
Post-ictal agitation score
Post-ictal agitation (PIA) score (1 = calm or asleep, 2 =rest less but calmed down when talked to, 3=restless and required a nurse to stand next to the bed, 4=one or more nurses were required to physically hold down the patient).
Time frame: In PACU immediately after ECT.
Maximum RASS score (Richmond Agitation-Sedation Scale)
RASS score is used to evaluation level of agitation/sedation.
Time frame: In PACU immediately after ECT.
Need for medications to treat post-ECT agitation
We will record if any additional sedating medications were needed in the PACU to treat post-ECT agitation
Time frame: PACU
Pre-ECT anxiety
We will calculate the change in visual analog anxiety scale reported by patients before and after weighted blanket use in the pre-ECT waiting area
Time frame: Pre-ECT waiting area
Plan to share: No — All patient data will be de-identified.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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