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Effect of Aggression Management Care Bundle

Effect of Using Care Bundle in the Aggression Management of Patients With Psychotic Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06661824
Enrollment
24
Registered
2024-10-28
Start date
2024-07-30
Completion date
2025-02-28
Last updated
2025-07-14

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

Conditions

Aggression

Keywords

Psychotic disorders, Psychiatric wards, Psychiatric care, Care bundle, Aggression management, Care package

Brief 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.

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.

Interventions

BEHAVIORALAggression management care bundle

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.

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

Patients and nurses do not know which group they are in, or which experimental or control groups they are in. The first tests were taken after patient consent to ensure blinding, but without assignment to groups.

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in aggression risk during hospitalizationup 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 hospitalizationup 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 hoursup 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.

Secondary

MeasureTime frameDescription
care bundle compliance rateup to 6 weeks (routine hospitalization period)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026