AggressionNCT06661824
Effect of Aggression Management Care Bundle
A study testing Aggression management care bundle in people with Aggression, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Aggression
- What is being tested?
- Aggression management care bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Mental Health and Diseases Hospital
Bolu, Bolu, 141000
About this study
Official title: Effect of Using Care Bundle in the Aggression Management of Patients With Psychotic Disorders
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:
- The aggression management care bundle applied to patients with psychotic disorders in a psychiatric clinic will reduce the risk of developing aggression.
- 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.
- The use of restrictive aggression management techniques in the clinic will decrease.
- The clinical compliance rate of the developed aggression management care bundle will be 95% and above.
Read the detailed description
Psychopathology plays an important role in the emergence of aggression. Having a diagnosis of psychotic disorder or schizophrenia is an important psychopathology that leads to aggression. For these reasons, aggression and how to manage it is an ongoing problem in psychiatric clinics. The prevalence of aggressive behavior in psychiatric wards varies between 8-76%. The prevalence of aggression in schizophrenia patients is stated as 33.3%. This aggression can be verbal, directed towards objects/spaces, towards oneself or physical aggression towards others. Healthcare professionals in psychiatric wards are exposed to these aggressive events carried out by patients. It is reported that 25-85% of healthcare professionals working in psychiatric wards are exposed to aggressive events; the prevalence of aggression towards nurses varies between 11.4-97.6%. Over the years, some methods have been developed and used to manage aggression in psychiatric wards. Chemical and mechanical restraint and seclusion methods are still the leading methods used. There is a need for alternative and evidence-based interventions based on therapeutic nursing approaches to manage aggression in psychiatric wards, which can be easily adopted and implemented in the clinic. Therefore, it was aimed to develop and use the "care bundle" approach, which has been shown to improve patient outcomes in the literature, for aggression management in psychiatric wards. Care bundles are care tools that target a specific patient population, consist of 3-5 evidence-based approaches, and improve patient outcomes when used together. In this study, it was planned to develop the aggression management care package in phase 1, and evaluate the clinical use of the aggression management care bundle in phase 2. The aggression management care bundle was developed following the guidelines of The Institute for Healthcare Improvement.
- Conditions
- Aggression
- Being tested
- Aggression management care bundle
- Keywords
- Psychotic disorders, Psychiatric wards, Psychiatric care, Care bundle, Aggression management, Care package
- Medical subject headings
- Aggression, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggression management care bundleBehavioural
The aggression management care bundle consists of six components. All of these are high-evidence level interventions consisting of behavioral and nursing interventions aimed at managing aggression. These six interventions are: Risk Assessment, Cognitive Remediation Training, Social Skills Training, De-Escalation Techniques, Milieu Therapy, Improving Sleep.
| Study group | Role | What they receive |
|---|---|---|
| Control group (routine care) | No intervention | Patients in the control group will be given routine care by clinic nurses. There are aggression management interventions that the clinic has adopted so far. In the face of an aggressive event, 1. contact the patient, 2. notify the physician and perform chemical restraint according to the order, 3. perform mechanical restraint and seclusion according to the patient's condition. The researcher will not be involved and will not intervene at this stage. The same scales will be applied to the patients as the experimental group. |
| experimental group (aggression management care bundle) | Experimental | The elements of the aggression management care bundle (risk assessment, cognitive remediation training, social skills training, tension reduction techniques, environmental therapy, improving sleep) developed for the experimental group will be applied by the clinical nurses and the researcher. Data will be collected by applying the same scales to the patients as the control group. Receives: Behavioral: Aggression management care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aggression risk during hospitalization
The primary outcome 1 measure of the study is change in aggression during hospitalization. Aggression risk will be measured in both groups with scales:
Buss-Perry Aggression Questionnaire (BAQ):29-item scale measuring four aggression sub-dimensions on a 5-point Likert scale. Total score: 29-145. Higher scores indicate higher aggression risk.
Change in aggression risk will be compared between hospitalization and discharge, and between control and experimental groups.
Measured: up to 6 weeks (routine hospitalization period)
Change in aggressive events during hospitalization
The primary outcome 2 measure of the study is change in aggression during hospitalization.
Aggressive events will be measured in both groups with this scale:
Overt Aggression Scale:Assesses aggression through professional observation. Two sections: Aggressive Behavior and Attempts. Scores: Total Aggression (max 26) and Aggression Score (max 21). Measures severity and frequency of aggressive behavior.
Change in aggressive events will be compared between hospitalization and discharge, and between control and experimental groups.
Measured: up to 6 weeks (routine hospitalization period)
Change in aggression risk during 24 hours
The primary outcome 3 measure of the study is change in aggression during 24 hours. Aggression risk will be measured in both groups with scale:
Broset Violence Checklist (BVC):Estimates 24-hour violence risk in acute psychiatric settings. Six behaviors scored 0 or 1. Total score: 0-6. 0 = low risk, 1-2 = medium risk, >2 = high risk.
Change in aggression risk in during 24 hours will be compared between hospitalization and discharge, and between control and experimental groups.
Measured: up to 6 weeks (routine hospitalization period)
Secondary outcomes (1)
care bundle compliance rate
The secondary outcome measure is the bundle compliance rate to evaluate the feasibility of the developed care bundle.The care bundle must be adoptable and applicable by nurses. To evaluate this, the number of times they apply which elements will be recorded with the Bundle Compliance Tracking Chart. Consistency and applicability among nurses will be examined. The implementation of the bundle at 95% and above means compliance.
Bundle Compliance Tracking Chart:It was created by researchers. It will be used to mark each element of the six-component care package to be applied to the intervention group as applied to the patient.Thus, it will be tracked which elements are applicable, which cannot be implemented and why, and how many times the elements are implemented.
Measured: up to 6 weeks (routine hospitalization period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Jul 2024
- Primary completion30 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In order to keep the clinic, health worker and other conditions that may affect the development of aggression constant, a sequential design was preferred. A single clinic was determined for the study. The care bundle is a clinical tool. Therefore, the interventions begin when the patient is admitted to the clinic and end with discharge. First, the routine care and routine aggression management interventions adopted in the clinic will be applied to the control group. At this stage, the staff and patients are blinded. After the control group sample size determined according to the sample calculation is completed, the experimental group intervention will begin. Training will be given to the clinic nurses regarding the care bundle to be applied. Then, the experimental group will be recruited and the experimental group application will begin.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa BULUT, Abant Izzet Baysal University
- Investigators
- Melisa Bulut, RN, PhD cand, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661824
- Sponsor's protocol ID
- AIBU-PSK-MB-02
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing data of psychiatric patients may pose some ethical and legal problems.
Publications
Ajnakina O, Stubbs B, Francis E, Gaughran F, David AS, Murray RM, Lally J. Hospitalisation and length of hospital stay following first-episode psychosis: systematic review and meta-analysis of longitudinal studies. Psychol Med. 2020 Apr;50(6):991-1001. doi: 10.1017/S0033291719000904. Epub 2019 May 6.
PubMed 31057129di Giacomo, E. et al. (2020). Prevalence and Risk Factors of Violence by Psychiatric Acute Inpatients: Systematic Review and Meta-Analysis-A 2019 Update. In: Carpiniello, B., Vita, A., Mencacci, C. (eds) Violence and Mental Disorders. Comprehensive Approach to Psychiatry, vol 1. Springer, Cham. https://doi.org/10.1007/978-3-030-33188-7_10
Dike CC, Lamb-Pagone J, Howe D, Beavers P, Bugella BA, Hillbrand M. Implementing a program to reduce restraint and seclusion utilization in a public-sector hospital: Clinical innovations, preliminary findings, and lessons learned. Psychol Serv. 2021 Nov;18(4):663-670. doi: 10.1037/ser0000502. Epub 2020 Sep 17.
PubMed 32940500Fernandez-Costa D, Gomez-Salgado J, Fagundo-Rivera J, Martin-Pereira J, Prieto-Callejero B, Garcia-Iglesias JJ. Alternatives to the Use of Mechanical Restraints in the Management of Agitation or Aggressions of Psychiatric Patients: A Scoping Review. J Clin Med. 2020 Aug 29;9(9):2791. doi: 10.3390/jcm9092791.
PubMed 32872463Gautam S, Gautam M, Yadav KS, Chaudhary J, Jain A. Clinical Practice Guidelines for Assessment and Management of Aggressive and Assaultive Behaviour. Indian J Psychiatry. 2023 Feb;65(2):131-139. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_518_22. Epub 2023 Jan 30. No abstract available.
PubMed 37063635Gaynes BN, Brown CL, Lux LJ, Brownley KA, Van Dorn RA, Edlund MJ, Coker-Schwimmer E, Weber RP, Sheitman B, Zarzar T, Viswanathan M, Lohr KN. Preventing and De-escalating Aggressive Behavior Among Adult Psychiatric Patients: A Systematic Review of the Evidence. Psychiatr Serv. 2017 Aug 1;68(8):819-831. doi: 10.1176/appi.ps.201600314. Epub 2017 Apr 17.
PubMed 28412887Huckshorn KA. Reducing seclusion restraint in mental health use settings: core strategies for prevention. J Psychosoc Nurs Ment Health Serv. 2004 Sep;42(9):22-33. doi: 10.3928/02793695-20040901-05.
PubMed 15493493Kernaghan K, Hurst K. Reducing violence and aggression: a quality improvement project for safety on an acute mental health ward. BMJ Open Qual. 2023 Dec 28;12(4):e002448. doi: 10.1136/bmjoq-2023-002448.
PubMed 38154818Lavallee JF, Gray TA, Dumville J, Russell W, Cullum N. The effects of care bundles on patient outcomes: a systematic review and meta-analysis. Implement Sci. 2017 Nov 29;12(1):142. doi: 10.1186/s13012-017-0670-0.
PubMed 29187217
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Care Bundle in the Aggression Management of Patients With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT06661824
- Acronym / sponsor ID
- AIBU-PSK-MB-02
- Conditions
- Aggression
- Keywords
- Psychotic disorders, Psychiatric wards, Psychiatric care, Care bundle, Aggression management, Care package
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 28 Oct 2024 (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 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:
- The aggression management care bundle applied to patients with psychotic disorders in a psychiatric clinic will reduce the risk of developing aggression.
- 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.
- The use of restrictive aggression management techniques in the clinic will decrease.
- The clinical compliance rate of the developed aggression management care bundle will be 95% and above.
Detailed description
Psychopathology plays an important role in the emergence of aggression. Having a diagnosis of psychotic disorder or schizophrenia is an important psychopathology that leads to aggression. For these reasons, aggression and how to manage it is an ongoing problem in psychiatric clinics. The prevalence of aggressive behavior in psychiatric wards varies between 8-76%. The prevalence of aggression in schizophrenia patients is stated as 33.3%. This aggression can be verbal, directed towards objects/spaces, towards oneself or physical aggression towards others. Healthcare professionals in psychiatric wards are exposed to these aggressive events carried out by patients. It is reported that 25-85% of healthcare professionals working in psychiatric wards are exposed to aggressive events; the prevalence of aggression towards nurses varies between 11.4-97.6%. Over the years, some methods have been developed and used to manage aggression in psychiatric wards. Chemical and mechanical restraint and seclusion methods are still the leading methods used. There is a need for alternative and evidence-based interventions based on therapeutic nursing approaches to manage aggression in psychiatric wards, which can be easily adopted and implemented in the clinic. Therefore, it was aimed to develop and use the "care bundle" approach, which has been shown to improve patient outcomes in the literature, for aggression management in psychiatric wards. Care bundles are care tools that target a specific patient population, consist of 3-5 evidence-based approaches, and improve patient outcomes when used together. In this study, it was planned to develop the aggression management care package in phase 1, and evaluate the clinical use of the aggression management care bundle in phase 2. The aggression management care bundle was developed following the guidelines of The Institute for Healthcare Improvement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- In order to keep the clinic, health worker and other conditions that may affect the development of aggression constant, a sequential design was preferred. A single clinic was determined for the study. The care bundle is a clinical tool. Therefore, the interventions begin when the patient is admitted to the clinic and end with discharge. First, the routine care and routine aggression management interventions adopted in the clinic will be applied to the control group. At this stage, the staff and patients are blinded. After the control group sample size determined according to the sample calculation is completed, the experimental group intervention will begin. Training will be given to the clinic nurses regarding the care bundle to be applied. Then, the experimental group will be recruited and the experimental group application will begin.
| Arm | Type | Receives |
|---|---|---|
| Control group (routine care) | No intervention | –Patients in the control group will be given routine care by clinic nurses. There are aggression management interventions that the clinic has adopted so far. In the face of an aggressive event, 1. contact the patient, 2. notify the physician and perform chemical restraint according to the order, 3. perform mechanical restraint and seclusion according to the patient's condition. The researcher will not be involved and will not intervene at this stage. The same scales will be applied to the patients as the experimental group. |
| experimental group (aggression management care bundle) | Experimental | Behavioral: Aggression management care bundleThe elements of the aggression management care bundle (risk assessment, cognitive remediation training, social skills training, tension reduction techniques, environmental therapy, improving sleep) developed for the experimental group will be applied by the clinical nurses and the researcher. Data will be collected by applying the same scales to the patients as the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Aggression management care bundleThe aggression management care bundle consists of six components. All of these are high-evidence level interventions consisting of behavioral and nursing interventions aimed at managing aggression. These six interventions are: Risk Assessment, Cognitive Remediation Training, Social Skills Training, De-Escalation Techniques, Milieu Therapy, Improving Sleep. | Behavioural | experimental group (aggression management care bundle) |
Primary outcome
Change in aggression risk during hospitalization
Time frame: up to 6 weeks (routine hospitalization period)
The primary outcome 1 measure of the study is change in aggression during hospitalization. Aggression risk will be measured in both groups with scales: Buss-Perry Aggression Questionnaire (BAQ):29-item scale measuring four aggression sub-dimensions on a 5-point Likert scale. Total score: 29-145. Higher scores indicate higher aggression risk. Change in aggression risk will be compared between hospitalization and discharge, and between control and experimental groups.
Change in aggressive events during hospitalization
Time frame: up to 6 weeks (routine hospitalization period)
The primary outcome 2 measure of the study is change in aggression during hospitalization. Aggressive events will be measured in both groups with this scale: Overt Aggression Scale:Assesses aggression through professional observation. Two sections: Aggressive Behavior and Attempts. Scores: Total Aggression (max 26) and Aggression Score (max 21). Measures severity and frequency of aggressive behavior. Change in aggressive events will be compared between hospitalization and discharge, and between control and experimental groups.
Change in aggression risk during 24 hours
Time frame: up to 6 weeks (routine hospitalization period)
The primary outcome 3 measure of the study is change in aggression during 24 hours. Aggression risk will be measured in both groups with scale: Broset Violence Checklist (BVC):Estimates 24-hour violence risk in acute psychiatric settings. Six behaviors scored 0 or 1. Total score: 0-6. 0 = low risk, 1-2 = medium risk, >2 = high risk. Change in aggression risk in during 24 hours will be compared between hospitalization and discharge, and between control and experimental groups.
1 secondary outcome
care bundle compliance rate
Time frame: up to 6 weeks (routine hospitalization period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 31057129Ajnakina O, Stubbs B, Francis E, Gaughran F, David AS, Murray RM, Lally J. Hospitalisation and length of hospital stay following first-episode psychosis: systematic review and meta-analysis of longitudinal studies. Psychol Med. 2020 Apr;50(6):991-1001. doi: 10.1017/S0033291719000904. Epub 2019 May 6.
- Backgrounddi Giacomo, E. et al. (2020). Prevalence and Risk Factors of Violence by Psychiatric Acute Inpatients: Systematic Review and Meta-Analysis-A 2019 Update. In: Carpiniello, B., Vita, A., Mencacci, C. (eds) Violence and Mental Disorders. Comprehensive Approach to Psychiatry, vol 1. Springer, Cham. https://doi.org/10.1007/978-3-030-33188-7_10
- Background: PubMed 32940500Dike CC, Lamb-Pagone J, Howe D, Beavers P, Bugella BA, Hillbrand M. Implementing a program to reduce restraint and seclusion utilization in a public-sector hospital: Clinical innovations, preliminary findings, and lessons learned. Psychol Serv. 2021 Nov;18(4):663-670. doi: 10.1037/ser0000502. Epub 2020 Sep 17.
- Background: PubMed 32872463Fernandez-Costa D, Gomez-Salgado J, Fagundo-Rivera J, Martin-Pereira J, Prieto-Callejero B, Garcia-Iglesias JJ. Alternatives to the Use of Mechanical Restraints in the Management of Agitation or Aggressions of Psychiatric Patients: A Scoping Review. J Clin Med. 2020 Aug 29;9(9):2791. doi: 10.3390/jcm9092791.
- Background: PubMed 37063635Gautam S, Gautam M, Yadav KS, Chaudhary J, Jain A. Clinical Practice Guidelines for Assessment and Management of Aggressive and Assaultive Behaviour. Indian J Psychiatry. 2023 Feb;65(2):131-139. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_518_22. Epub 2023 Jan 30. No abstract available.
- Background: PubMed 28412887Gaynes BN, Brown CL, Lux LJ, Brownley KA, Van Dorn RA, Edlund MJ, Coker-Schwimmer E, Weber RP, Sheitman B, Zarzar T, Viswanathan M, Lohr KN. Preventing and De-escalating Aggressive Behavior Among Adult Psychiatric Patients: A Systematic Review of the Evidence. Psychiatr Serv. 2017 Aug 1;68(8):819-831. doi: 10.1176/appi.ps.201600314. Epub 2017 Apr 17.
- Background: PubMed 15493493Huckshorn KA. Reducing seclusion restraint in mental health use settings: core strategies for prevention. J Psychosoc Nurs Ment Health Serv. 2004 Sep;42(9):22-33. doi: 10.3928/02793695-20040901-05.
- Background: PubMed 38154818Kernaghan K, Hurst K. Reducing violence and aggression: a quality improvement project for safety on an acute mental health ward. BMJ Open Qual. 2023 Dec 28;12(4):e002448. doi: 10.1136/bmjoq-2023-002448.
- Background: PubMed 29187217Lavallee JF, Gray TA, Dumville J, Russell W, Cullum N. The effects of care bundles on patient outcomes: a systematic review and meta-analysis. Implement Sci. 2017 Nov 29;12(1):142. doi: 10.1186/s13012-017-0670-0.
- IHI The Institute for Healthcare Improvement. (2012). What is a bundle?Link provided by the sponsor.
- Resar R, Griffin FA, Haraden C, Nolan TW. Using Care Bundles to Improve Health Care Quality. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; 2012.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Sharing data of psychiatric patients may pose some ethical and legal problems.
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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. This study is not recruiting at the moment.
Melisa Bulut, RN, PhD cand principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aggression management care bundle in people with Aggression, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2025. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aggression risk during hospitalization (time frame: up to 6 weeks (routine hospitalization period)). The study lists 3 primary outcomes in all. 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 NCT06661824, which also lists 9 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 14 Jul 2025.