- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946720
Aggression From the Perspective of Patients and Nurses
Aggression From the Perspective of Patients and Nurses: An Integrated Study on the Evaluation of Aggression in Psychiatric Clinics
The research, was planned in a randomized controlled design, aiming to evaluate the effect of the training given to nurses working in psychiatric clinics on the use of aggression and BVC (Broset Violence Checklist) on the nurses' perceptions of aggression and the compliance of the use of BVC, which they evaluated for the patients watched in the videos, with the BVC determined by expert opinion.
The study was conducted in Adana Doctor Ekrem Tok Mental Health and Diseases Hospital between July 2021 and April 2022. A total of 97 nurses working in psychiatric clinics, 47 in the training group and 50 in the comparison group, participated in the study. A pre-test was administered to the nurses and nurses in the training group were randomized and given training including aggression and BVC use. After the training, a post-test was administered to all nurses.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Adana, Turkey, 01180
- Cukurova Universitesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the research,
- To have been working in the hospital where the research was conducted for at least 1 year,
- To have no vision, hearing and speech problems.
Exclusion Criteria:
- To want to withdraw from the research at any stage of the research,
- Not completing or not being able to complete the research for any reason,
- To work in the filiation team during the research process.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taining group
Nurses in the training group were given training on aggression and the use of BVC.
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After obtaining verbal consent from the nurses who met the inclusion criteria of the study before the pre-test was applied to the nurses, the nurses who volunteered to participate in the study were randomized within their own clinic using the simple randomization method.
For this, after the data collection form was distributed before the pre-test, the nurses were asked to write the letter that came to them on the data collection form and not forget it.
In order for nurses to be included in the training or comparison group, the letter A, written on the closed papers in the box prepared for simple randomization, represents the Education group, and the letter B represents the comparison group.
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No Intervention: Control group
Nurses in the control group were not trained, till the study ends.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Aggression Scale
Time Frame: Procedure (one week before the training)
|
The scale has a 5-point Likert-type rating system ranging from strongly disagree (1) to strongly agree (5) and consists of 29 items.
The items have two subscales: functional (functional - acceptable / healthy response) and dysfunctional (dysfunctional - unacceptable / undesirable aggression).
For each subscale, the average of the relevant item scores will be calculated.
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Procedure (one week before the training)
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Broset Violence Checklist
Time Frame: Procedure (one week before the training and one day after the training)
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A score of "1" is given in the presence of each item of the BVC, and "0" in the absence of it.
In the next evaluations of the patient, if there is an increase in the relevant item compared to the previous one, the behavior score is scored as "1", the habitual or same level behavior is considered absent and scored as "0".
If there is no more in the case of a patient with a flood than before, the relevant item score should be "0".
If an increase in the level of exuberance is observed, it should be scored as "1".
After the six items are scored in this way, the evaluation is made over the total score.
A total score of "0" indicates that the patient has a low severity risk level.
"1- 2 points" indicates moderate risk of violence and necessitates measures to prevent violence.
"3-6 points" refers to a high risk of violence.
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Procedure (one week before the training and one day after the training)
|
Perception of Aggression Scale
Time Frame: Procedure (one day after the training)
|
The scale has a 5-point Likert-type rating system ranging from strongly disagree (1) to strongly agree (5) and consists of 29 items.
The items have two subscales: functional (functional - acceptable / healthy response) and dysfunctional (dysfunctional - unacceptable / undesirable aggression).
For each subscale, the average of the relevant item scores will be calculated.
|
Procedure (one day after the training)
|
Broset Violence Checklist
Time Frame: Procedure (one day after the training)
|
A score of "1" is given in the presence of each item of the BVC, and "0" in the absence of it.
In the next evaluations of the patient, if there is an increase in the relevant item compared to the previous one, the behavior score is scored as "1", the habitual or same level behavior is considered absent and scored as "0".
If there is no more in the case of a patient with a flood than before, the relevant item score should be "0".
If an increase in the level of exuberance is observed, it should be scored as "1".
After the six items are scored in this way, the evaluation is made over the total score.
A total score of "0" indicates that the patient has a low severity risk level.
"1- 2 points" indicates moderate risk of violence and necessitates measures to prevent violence.
"3-6 points" refers to a high risk of violence.
|
Procedure (one day after the training)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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