Effect of Aggression Management Care Bundle (NCT06661824) | Clinical Trial Compass
CompletedNot Applicable
Effect of Aggression Management Care Bundle
Turkey (Türkiye)24 participantsStarted 2024-07-30
Plain-language summary
The aim of this sequential randomized controlled experimental design study is to develop an aggression care bundle approach in psychiatric care for patients with psychotic disorders, to use it in a psychiatric clinic, and to evaluate its results. The hypotheses it aims to test are as follows:
1. The aggression management care bundle applied to patients with psychotic disorders in a psychiatric clinic will reduce the risk of developing aggression.
2. The number of aggressive events in the patient group to whom the aggression management care bundle is applied will be less than the control group receiving routine care.
3. The use of restrictive aggression management techniques in the clinic will decrease.
4. The clinical compliance rate of the developed aggression management care bundle will be 95% and above.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being between 18-65 years of age,
* Being able to speak and understand Turkish,
* Having one of the disorders within the scope of Schizophrenia and psychosis,
* Being newly admitted to Bolu İzzet Baysal Mental Health and Diseases Hospital during the period the research was conducted,
* Having scored 1 point or more on the Broset Violence Checklist or 65 points or more on the Buss-Perry Aggression Questionnaire.
Exclusion Criteria:
* Not being able to give written informed consent,
* Being the first time a patient has been admitted to a psychiatric clinic,
* Having developmental delay or any other significant organic brain pathology.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in aggression risk during hospitalization
Timeframe: up to 6 weeks (routine hospitalization period)
2
Change in aggressive events during hospitalization
Timeframe: up to 6 weeks (routine hospitalization period)
3
Change in aggression risk during 24 hours
Timeframe: up to 6 weeks (routine hospitalization period)