Post-ect AgitationNCT07900646
Peri-procedural Weighted Blanket Use for ECT
A study testing Weighted blanket in people with Post-ect Agitation and Post-ictal Agitation, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ect Agitation, Post-ictal Agitation
- What is being tested?
- Weighted blanket
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized
- Undergoing induction series of ECT
Who cannot join
- Unable to complete visual analog anxiety assessment scale
- Court-ordered ECT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Rochester, Minnesota, 55902
Ruth DeFoster, MD, 507-255-8716
About this study
Official title: Effect of Peri-procedural Weighted Blanket Use on Pre-ECT Anxiety and Post-ECT Agitation: A Pilot Crossover Design RCT Study.
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.
Read the detailed description
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:
- Maximum RASS score (Richmond Agitation-Sedation Scale)
- Need for medications to manage post-ictal agitation (prescribed after ECT in response to PIA and not part of the original medication orders prior to ECT) (Y/N).
- Change in visual analog anxiety scale before and after weighted blanket use in the pre-ECT waiting area
- Conditions
- Post-ect Agitation, Post-ictal Agitation
- Being tested
- Weighted blanket, Usual Care Group
- Keywords
- ect, weighted blankets
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted blanketOther
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.
Usual Care GroupOther
Patients receiving usual care will receive non-weighted blankets
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Experimental | 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 Receives: Other: Weighted blanket |
| Usual care | Placebo comparator | 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 Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: In PACU immediately after ECT.
Secondary outcomes (3)
Maximum RASS score (Richmond Agitation-Sedation Scale)
RASS score is used to evaluation level of agitation/sedation.
Measured: 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
Measured: 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
Measured: Pre-ECT waiting area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-ect AgitationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study design: Pilot Crossover design RCT 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth E Bates, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900646
- Sponsor's protocol ID
- 26-011035
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data will be de-identified.
Publications
Ertman M, van der Valk Bouman ES, Clephas PRD, Birkenhager TK, Klimek M. Prognostic Factors and Incidence for Postictal Agitation After Electroconvulsive Therapy: A Systematic Review and Meta-analysis. J ECT. 2025 Mar 1;41(1):17-26. doi: 10.1097/YCT.0000000000001032. Epub 2024 Aug 22.
PubMed 39105589Dickson DA, Gantt L, Swanson M. Effectiveness of the Weighted Blanket With Psychiatric Patients in the Emergency Department: A Pilot Study. J Am Psychiatr Nurses Assoc. 2023 Jul-Aug;29(4):307-313. doi: 10.1177/10783903211026740. Epub 2021 Jun 24.
PubMed 34166155Allen ND, Allison CL, Golebiowski R, Janowski JPB, LeMahieu AM, Geske JR, Rasmussen KG. Factors Associated With Postictal Agitation After Electroconvulsive Therapy. J ECT. 2022 Mar 1;38(1):60-61. doi: 10.1097/YCT.0000000000000807.
PubMed 34739422
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peri-procedural Weighted Blanket Use on Pre-ECT Anxiety and Post-ECT Agitation: A Pilot Crossover Design RCT Study.
- ClinicalTrials.gov ID
- NCT07900646
- Acronym / sponsor ID
- 26-011035
- Conditions
- Post-ect Agitation, Post-ictal Agitation
- Keywords
- ect, weighted blankets
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Maximum RASS score (Richmond Agitation-Sedation Scale)
- Need for medications to manage post-ictal agitation (prescribed after ECT in response to PIA and not part of the original medication orders prior to ECT) (Y/N).
- Change in visual analog anxiety scale before and after weighted blanket use in the pre-ECT waiting area
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design: Pilot Crossover design RCT 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.
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Experimental | Other: Weighted blanketIntervention - 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 |
| Usual care | Placebo comparator | Other: Usual Care GroupUsual 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized
- Undergoing induction series of ECT
Key exclusion criteria (2 listed)
- Unable to complete visual analog anxiety assessment scale
- Court-ordered ECT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted blanketWeighted 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. | Other | Weighted blanket |
| Usual Care GroupPatients receiving usual care will receive non-weighted blankets | Other | Usual care |
Primary outcome
Post-ictal agitation score
Time frame: In PACU immediately after ECT.
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).
3 secondary outcomes
Maximum RASS score (Richmond Agitation-Sedation Scale)
Time frame: In PACU immediately after ECT.
Need for medications to treat post-ECT agitation
Time frame: PACU
Pre-ECT anxiety
Time frame: Pre-ECT waiting area
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 39105589Ertman M, van der Valk Bouman ES, Clephas PRD, Birkenhager TK, Klimek M. Prognostic Factors and Incidence for Postictal Agitation After Electroconvulsive Therapy: A Systematic Review and Meta-analysis. J ECT. 2025 Mar 1;41(1):17-26. doi: 10.1097/YCT.0000000000001032. Epub 2024 Aug 22.
- Background: PubMed 34166155Dickson DA, Gantt L, Swanson M. Effectiveness of the Weighted Blanket With Psychiatric Patients in the Emergency Department: A Pilot Study. J Am Psychiatr Nurses Assoc. 2023 Jul-Aug;29(4):307-313. doi: 10.1177/10783903211026740. Epub 2021 Jun 24.
- Background: PubMed 34739422Allen ND, Allison CL, Golebiowski R, Janowski JPB, LeMahieu AM, Geske JR, Rasmussen KG. Factors Associated With Postictal Agitation After Electroconvulsive Therapy. J ECT. 2022 Mar 1;38(1):60-61. doi: 10.1097/YCT.0000000000000807.
- Individual participant dataSharing planned: No. All patient data will be de-identified.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted blanket in people with Post-ect Agitation and Post-ictal Agitation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth DeFoster, MD (507-255-8716, DeFoster.ruth@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ictal agitation score (time frame: In PACU immediately after ECT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07900646, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.