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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03924141
Other study ID # 716537
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2019
Est. completion date June 30, 2020

Study information

Verified date August 2020
Source Bergen University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 30, 2020
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Third year nursing student

Exclusion Criteria:

- Has to talk and understand Norwegian

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Training in de-escalation
Will receive one hour of de-escalation training

Locations

Country Name City State
Norway Bergen University College Bergen

Sponsors (2)

Lead Sponsor Collaborator
Bergen University College Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in de-escalation skills: Baseline Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi & Bieling, 2016) Immediately before and immediately after intervention (single day, baseline)
Primary Changes in de-escalation skills Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi & Bieling, 2016) Immediately before and immediately after intervention (single day, 6 months post-baseline)
Primary Changes in de-escalation skills Instrument: "English Modified De-escalating Aggressive Behaviour Scale" (Mavandadi & Bieling, 2016) Immediately before and immediately after intervention (single day, 9 months post-baseline)
Secondary Changes in coping and confidence Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987) Immediately before and immediately after intervention (single day, baseline)
Secondary Changes in coping and confidence Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987) Immediately before and immediately after intervention (single day, 6 months post-baseline)
Secondary Changes in coping and confidence Instrument: "Clinicians confidence in coping with patient aggression" (Thackreys, 1987) Immediately before and immediately after intervention (single day, 9 months post-baseline)