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TREC-SAVE: a trial for aggressive or violent seriously mentally ill people

Randomised controlled trial comparing mechanical restraints with seclusion for aggressive mentally ill people in emergency psychiatric hospitals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49454276
Enrollment
100
Registered
2011-03-04
Start date
2010-06-16
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive/violent mental illness Mental and Behavioural Disorders Aggressive/violent mental illness

Interventions

1. Use of four point physical restraint (cotton bands) and policy of close recording of mental state, behaviour, wellbeing, in addition to standard use of medication. 2. Use of secure seclusion room a

Sponsors

National Institute of Quality Control in Health (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Anyone (no age or gender limits) thought to have a serious mental illness admitted to the hospital who has a degree or risk of aggression or violent behaviour that endangers themselves or others 2. Who is thought by medical and nursing staff to need some form of physical restriction 3. For whom the medical and nursing staff have doubt as to whether one form of restriction is better than the other

Exclusion criteria

Exclusion criteria: 1. Anyone for whom either or both packages of care are contraindicated by either medical or nursing staff 2. Anyone already randomised in this trial

Design outcomes

Primary

MeasureTime frame
Time to release from restraints or seclusion

Secondary

MeasureTime frame
1. Safe resolution of episode, measured 24 hours after the beginning of the episode 2. Time in restriction, measured 24 hours after the beginning of the episode 3. Further episode, measured 24 hours after the beginning of the episode 4. Need to call the doctor on an emergency basis, measured 24 hours after the beginning of the episode 5. Refusal of oral medication, measured 24 hours after the beginning of the episode 6. Amount of medication and how administered, measured 24 hours after the beginning of the episode 7. Acceptability to patient/staff, measured 24 hours after the beginning of the episode 8. Adverse effects, measured at 2 weeks 9. Time to discharge, measured at 2 weeks

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026