Effect of Aggression Management Care Bundle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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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

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Aggression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Aggression management care bundle

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No