- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924141
Evaluation of Training in De-escalation
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bergen, Norway
- Bergen University College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Third year nursing student
Exclusion Criteria:
- Has to talk and understand Norwegian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Third year nursing students - intervention
Third year nursing students will receive the intervention in de-escalation training
|
Will receive one hour of de-escalation training
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NO_INTERVENTION: Third year nursing students - control
Third year nursing students will receive no training in de-escalation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Immediately before and immediately after intervention (single day, baseline)
|
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)
|
Immediately before and immediately after intervention (single day, 6 months post-baseline)
|
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)
|
Immediately before and immediately after intervention (single day, 9 months post-baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in coping and confidence
Time Frame: Immediately before and immediately after intervention (single day, baseline)
|
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
|
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)
|
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
|
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)
|
Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987)
|
Immediately before and immediately after intervention (single day, 9 months post-baseline)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kjersti Alsaker, PhD, Bergen University College
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
- 716537
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
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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