AggressionNCT05946720
Aggression From the Perspective of Patients and Nurses
A study testing Training including aggression and the use of BVC. in people with Aggression, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aggression
- What is being tested?
- Training including aggression and the use of BVC.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 14 Apr 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aggression
- Being tested
- Training including aggression and the use of BVC.
- Keywords
- aggression, aggression in psychiatry clinics, perception of aggression, risk level of violence
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training including aggression and the use of BVC.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Taining group | Experimental | Nurses in the training group were given training on aggression and the use of BVC. Receives: Other: Training including aggression and the use of BVC. |
| Control group | No intervention | Nurses in the control group were not trained, till the study ends. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Aggression Scale
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.
Measured: Procedure (one week before the training)
Broset Violence Checklist
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.
Measured: Procedure (one week before the training and one day after the training)
Perception of Aggression Scale
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.
Measured: Procedure (one day after the training)
Broset Violence Checklist
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.
Measured: Procedure (one day after the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Jul 2021
- Primary completion10 Jul 2021
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre- post test, training and control group, randomise controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA TEK SEVİNDİK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946720
- Sponsor's protocol ID
- 117
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggression From the Perspective of Patients and Nurses: An Integrated Study on the Evaluation of Aggression in Psychiatric Clinics
- ClinicalTrials.gov ID
- NCT05946720
- Acronym / sponsor ID
- 117
- Conditions
- Aggression
- Keywords
- aggression, aggression in psychiatry clinics, perception of aggression, risk level of violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 14 Jul 2023 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- pre- post test, training and control group, randomise controlled trial
| Arm | Type | Receives |
|---|---|---|
| Taining group | Experimental | Other: Training including aggression and the use of BVC.Nurses in the training group were given training on aggression and the use of BVC. |
| Control group | No intervention | –Nurses in the control group were not trained, till the study ends. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Training including aggression and the use of BVC.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. | Other | Taining group |
Primary outcome
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.
Broset Violence Checklist
Time frame: Procedure (one week before the training and 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.
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.
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.
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 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training including aggression and the use of BVC. in people with Aggression, run by Muğla Sıtkı Koçman 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 3 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 2023. 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?
Perception of Aggression Scale (time frame: Procedure (one week before the training)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023; AzTrials last refreshed its copy on 6 Nov 2026.