Effect of Aggression Management Care Bundle

July 11, 2025 updated by: Melisa BULUT, Abant Izzet Baysal University

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bolu Province
      • Bolu, Bolu Province, Turkey, 141000
        • Bolu Mental Health and Diseases Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group (routine care)
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: experimental group (aggression management care bundle)
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.
Behavioral: Aggression 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 weeks (routine hospitalization period)
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.
up to 6 weeks (routine hospitalization period)
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.
up to 6 weeks (routine hospitalization period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
care bundle compliance rate
Time Frame: up 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.
up to 6 weeks (routine hospitalization period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Melisa Bulut, RN, PhD cand, Bolu abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-PSK-MB-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing data of psychiatric patients may pose some ethical and legal problems.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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