Condition category
Not Applicable
Date applied
05/06/2020
Date assigned
18/06/2020
Last edited
18/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Registered nurses (RNs) play a vital role in patients' pain management after surgery. Therefore, it is important for RNs to have adequate knowledge and documentation skills when it comes to postoperative pain care. The aim of this study is to develop and test a brief educational intervention based on Finnish acute postoperative pain nursing practice guidelines, in order to improve RNs’ knowledge of pain management and improve their postoperative documentation skills.

Who can participate?
Registered nurses (RNs) at a central hospital in Finland

What does the study involve?
RNs are randomly allocated to the intervention and control groups the day before the beginning of the intervention. All participants take the Acute Postoperative Pain Knowledge Test©. Once all participants respond to the test, the researcher calls out the names of individuals who are to leave the classroom and conduct the tests with the remaining nurses. The RNs who leave the classroom become members of the control group, and those who remain in the classroom belong to the intervention group. Only the intervention group RNs participate in the education intervention. The intervention lecture starts immediately after the control group leave the room. After the lecture, the intervention group again take the Acute Postoperative Pain Knowledge Test©. Three months after the intervention, the researcher directly conducts the retention test, personally asking the RNs to take the same test again. The researcher audits each RN's pain documentation from three different patient records before and after the intervention and after 3 months.

What are the possible benefits and risks of participating?
Half of the participating RNs receive a brief postoperative pain education. There are no risks of participating.

Where is the study run from?
Central Finland Health Care District (Central Finland Central Hospital)

When is the study starting and how long is it expected to run for?
October 2016 to July 2018

Who is funding the study?
Finnish Vascular Nursing Society (Suomen Verisuonihoitajayhdistys)

Who is the main contact?
Salla Grommi
sallagro@uef.fi

Trial website

Contact information

Type

Scientific

Primary contact

Miss Salla Grommi

ORCID ID

http://orcid.org/0000-0003-1448-5099

Contact details

University of Eastern Finland
Department of Nursing Science
Yliopistonranta 1 C
Kuopio
70211
Finland
+358 (0)505358453 or +358 (0)503017339
sallagro@uef.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Educating registered nurses in pain knowledge and documentation management: a randomized controlled trial

Acronym

Study hypothesis

H0: μc = μi and H1: μc < μi, where μc is the average change in RNs’ pain knowledge or documentation quality in the control group and μi is the average change in RNs’ pain knowledge or documentation quality in the intervention group. The threshold for statistical significance (p) is <0.05.

Alternatively, the hypothesis could be formulated as follows: H0: d ≤0.2 and H1: d >0.2, where d is 𝜇𝜇𝑖𝑖−𝜎𝜎𝜇𝜇𝑐𝑐 (Cohen 1988). In d, μi is the average change in RNs’ knowledge or documentation quality in the intervention group, μc is the average change in RNs’ knowledge or documentation quality in the control group, and σ is the combined standard deviation.

Ethics approval

This type of study does not require ethics approval in Finland, the target organization's study protocol and permission to start study are enough. The volunteers were informed about the purpose of the study and voluntary participation, and their written informed consent was taken.

Study design

Randomized controlled trial with a pre-, post-, and retention-tests design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format please use contact details to request a participant information sheet

Condition

RNs' postoperative pain knowledge and documentation

Intervention

In this study, RNs work in three selected surgical wards. Before the study, the researchers coordinate with the units’ nursing managers in order to bring the RNs to the training space. The RNs’ shifts are planned to begin and end earlier or later. Only the research team and nurse managers know the exact date of the intervention. On the previous day, the researcher (first author) allocates the RNs to groups (surgical ward 1, surgical ward 2, surgical ward 3 and vice staff personnel); then those four groups again are randomly placed into two groups (intervention and control groups). The participants are unaware of the allocation until the intervention.

The researchers implement the study on a single day in April 2017 between 12 am and 16 pm. On that day, all of the nursing staff working on the morning or evening shifts constitute the study population (N=50). On the intervention day, the evening shift RNs come to the training space at 12 am. The researcher first tell RNs about the research. If the RNs fill in the consent form, they agree to participate in the study. Second, all participants take the Acute Postoperative Pain Knowledge Test©. Once all participants respond to the test, the researcher calls out the names of individuals who are to leave the classroom and conduct the tests with the remaining nurses. The RNs who leave the classroom become members of the control group, and those who remained in the classroom belong to the intervention group. Only the intervention group RNs participate in the education intervention. The intervention lecture starts immediately after the control group left the room. After the lecture, the intervention group again take the Acute Postoperative Pain Knowledge Test©. After the intervention group take the test again, they go to their units to be relieved by the morning shift. Morning shift RNs come to the classroom at approximately 14 pm. The previous protocol is repeated in exactly the same manner. However, after the protocol, all morning-shifts RNs finish their workdays. This design aims to control the potential impact of the interaction between the intervention and control groups.

Three months after the intervention, the researcher directly conducts the retention test in work units, personally asking RNs to take the same test again. Tests are taken under the supervision of the researcher. A documentation audit is conducted retrospectively in spring and summer 2018. The researcher audit each RN’s documentation from three different patient records three times at the baseline, post and retention stages.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Pain knowledge measured using the Acute Postoperative Pain Knowledge Test© pre-intervention, post-intervention, and at 3 months

Secondary outcome measures

Pain documentation assessed using documentation audit pre-intervention, post-intervention, and at 3 months

Overall trial start date

01/10/2016

Overall trial end date

31/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The researchers implemented the study on a single day in April 2017 between 12 am and 16 pm. On that day, all of the nursing staff working on the morning or evening shifts constituted the study population (N=50) in three surgical wards.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

50

Total final enrolment

50

Participant exclusion criteria

Not working in the intervention day in three selected surgical wards, other profession than RN

Recruitment start date

18/04/2017

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Finland

Trial participating centre

Central Finland Health Care District
Keskussairaalantie 19
Jyväskylä
40620
Finland

Sponsor information

Organisation

University of Eastern Finland

Sponsor details

Department of Nursing Science
Itä-Suomen yliopisto
Hoitotieteen laitos
PL 1627
Kuopio
70211
Finland
+358 (0)403552629
hannele.turunen@uef.fi

Sponsor type

University/education

Website

http://www.uef.fi/en

Funders

Funder type

Other

Funder name

Finnish Vascular Nursing Society (Suomen Verisuonihoitajayhdistys)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication immediately after registration.

IPD sharing statement
The datasets analyzed during this study will be included in the subsequent results publication.

Intention to publish date

08/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/06/2020: Trial's existence confirmed by Central Finland Health Care District.