De-escalation SkillsNCT03924141
Evaluation of Training in De-escalation
A study testing Training in de-escalation in people with De-escalation Skills, run by Bergen University College at 1 site in Norway.
Trial summary
The purpose of the study is to evaluate one of the chapters in the new national Norwegian training manual (MAP). The chapter that is selected to be evaluated is the chapter on de-escalation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- De-escalation Skills
- What is being tested?
- Training in de-escalation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- 18 Feb 2019to 30 Jun 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Third year nursing student
Who cannot join
- Has to talk and understand Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Brief De-escalation Training Program on Student Nurses' Skills and Confidence Level in Coping With Patient Aggression: a Cluster Randomized Controlled Study
The purpose of the study is to evaluate one of the chapters in the new national Norwegian training manual (MAP). The chapter that is selected to be evaluated is the chapter on de-escalation. Effective training in this topic should not only lead to changes in the level of knowledge and attitudes, but also changes in behavior and skills. Experiencing better preparedness does not necessarily entail a change in behavior. This study wants to test whether training in de-escalation changes the participants' skills and experience of self-confidence, security and coping in threatening situations.
Read the detailed description
The theme is:
- Evaluation of the training program of de-escalation for third-year nursing students
Underlying research questions will be:
- Will the intervention provide increased de-escalation skills?
- Will training in de-escalation provide increased confidence in coping with patient aggression?
The design used to answer the research questions is a cluster-randomized controlled study with an intervention group and a control group.
The two study groups with nursing students will be exposed to two different scenarios (A and B) with simulated patient situations. Students will conduct simulation A before the intervention and simulation B the same day after the intervention. A control group will also be included which will review scenarios A and B without intervention. The purpose of this is to see if the scenarios in isolation give any effect on the pre- and post-measurements.
Participants will also be asked to complete a questionnaire (Thackreys, 1987) related to experienced coping security related to aggression management at four different times.
The scenarios will be recorded on video. Following all video data collection, 2 de-escalation experts will independently review the video data and quantify it using the EMDABS instrument. They will be blinded and not aware of whether the video was recorded before or after the intervention. The data that this generates will then be statistically examined.
The selection of participants will be made from three classes with third year nursing students. The classes consist of about 50 students. Participation is voluntary.
It is uncertain how many will participate, but on the basis of practical limits there is an upper limit of 15 participants per class for the intervention group (the selection is recruited from two classes), and 30 participants from the control group (the selection is recruited from a class). A total of n = 30 is desired in both the intervention group and the control group.
The following two outcomes will be analyzed; de-escalating behavior (EMDABS, Mavandadi et al., 2016) and confidence in coping with patient aggression (Thackrey, 1987).
- Conditions
- De-escalation Skills
- Being tested
- Training in de-escalation
- Keywords
- De-escalation, Aggression, Violence prevention
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in de-escalationBehavioural
Will receive one hour of de-escalation training
| Study group | Role | What they receive |
|---|---|---|
| Third year nursing students - intervention | Experimental | Third year nursing students will receive the intervention in de-escalation training Receives: Behavioral: Training in de-escalation |
| Third year nursing students - control | No intervention | Third year nursing students will receive no training in de-escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in de-escalation skills: Baseline
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
Measured: Immediately before and immediately after intervention (single day, baseline)
Changes in de-escalation skills
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
Measured: Immediately before and immediately after intervention (single day, 6 months post-baseline)
Changes in de-escalation skills
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
Measured: Immediately before and immediately after intervention (single day, 9 months post-baseline)
Secondary outcomes (3)
Changes in coping and confidence
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
Measured: Immediately before and immediately after intervention (single day, baseline)
Changes in coping and confidence
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
Measured: Immediately before and immediately after intervention (single day, 6 months post-baseline)
Changes in coping and confidence
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
Measured: Immediately before and immediately after intervention (single day, 9 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start18 Feb 2019
- Primary completion26 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De-escalation SkillsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bergen University College
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Principal investigator, Thomas Nag, Bergen University College
- Investigators
- Kjersti Alsaker, PhD, Study chair, Bergen University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924141
- Sponsor's protocol ID
- 716537
- Status last verified
- Aug 2020
- First submitted
- 10 Apr 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief De-escalation Training Program on Student Nurses' Skills and Confidence Level in Coping With Patient Aggression: a Cluster Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03924141
- Acronym / sponsor ID
- 716537
- Conditions
- De-escalation Skills
- Keywords
- De-escalation, Aggression, Violence prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bergen University CollegeUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Apr 2019 (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 purpose of the study is to evaluate one of the chapters in the new national Norwegian training manual (MAP). The chapter that is selected to be evaluated is the chapter on de-escalation. Effective training in this topic should not only lead to changes in the level of knowledge and attitudes, but also changes in behavior and skills. Experiencing better preparedness does not necessarily entail a change in behavior. This study wants to test whether training in de-escalation changes the participants' skills and experience of self-confidence, security and coping in threatening situations.
Detailed description
The theme is:
- Evaluation of the training program of de-escalation for third-year nursing students
Underlying research questions will be:
- Will the intervention provide increased de-escalation skills?
- Will training in de-escalation provide increased confidence in coping with patient aggression?
The design used to answer the research questions is a cluster-randomized controlled study with an intervention group and a control group.
The two study groups with nursing students will be exposed to two different scenarios (A and B) with simulated patient situations. Students will conduct simulation A before the intervention and simulation B the same day after the intervention. A control group will also be included which will review scenarios A and B without intervention. The purpose of this is to see if the scenarios in isolation give any effect on the pre- and post-measurements.
Participants will also be asked to complete a questionnaire (Thackreys, 1987) related to experienced coping security related to aggression management at four different times.
The scenarios will be recorded on video. Following all video data collection, 2 de-escalation experts will independently review the video data and quantify it using the EMDABS instrument. They will be blinded and not aware of whether the video was recorded before or after the intervention. The data that this generates will then be statistically examined.
The selection of participants will be made from three classes with third year nursing students. The classes consist of about 50 students. Participation is voluntary.
It is uncertain how many will participate, but on the basis of practical limits there is an upper limit of 15 participants per class for the intervention group (the selection is recruited from two classes), and 30 participants from the control group (the selection is recruited from a class). A total of n = 30 is desired in both the intervention group and the control group.
The following two outcomes will be analyzed; de-escalating behavior (EMDABS, Mavandadi et al., 2016) and confidence in coping with patient aggression (Thackrey, 1987).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Third year nursing students - intervention | Experimental | Behavioral: Training in de-escalationThird year nursing students will receive the intervention in de-escalation training |
| Third year nursing students - control | No intervention | –Third year nursing students will receive no training in de-escalation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Third year nursing student
Key exclusion criteria (1 listed)
- Has to talk and understand Norwegian
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 in de-escalationWill receive one hour of de-escalation training | Behavioural | Third year nursing students - intervention |
Primary outcome
Changes in de-escalation skills: Baseline
Time frame: Immediately before and immediately after intervention (single day, baseline)
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
Changes in de-escalation skills
Time frame: Immediately before and immediately after intervention (single day, 6 months post-baseline)
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
Changes in de-escalation skills
Time frame: Immediately before and immediately after intervention (single day, 9 months post-baseline)
Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi \& Bieling, 2016)
3 secondary outcomes
Changes in coping and confidence
Time frame: Immediately before and immediately after intervention (single day, baseline)
Changes in coping and confidence
Time frame: Immediately before and immediately after intervention (single day, 6 months post-baseline)
Changes in coping and confidence
Time frame: Immediately before and immediately after intervention (single day, 9 months post-baseline)
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 5 Aug 2020.
- Individual participant dataSharing planned: No
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.
Kjersti Alsaker, PhD study chair
Bergen University College
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 in de-escalation in people with De-escalation Skills, run by Bergen University College at 1 site in Norway.
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 1 inclusion and 1 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 5 Aug 2020. 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 Norway. 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?
Changes in de-escalation skills: Baseline (time frame: Immediately before and immediately after intervention (single day, baseline)). The study lists 3 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 5 Aug 2020.