Pediatric Pain Management - an Intervention Study

Postoperative Pain Clinical Trial

Official title:

Pediatric Pain Management in Post Anesthesia Care Units - an Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385681
• Other study ID #: 2014/7951
• Secondary ID: 2014/878
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore nurses' pediatric postoperative pain management knowledge and clinical practices. The aim is to evaluate if a tailored educational intervention will improve nurses' knowledge and attitudes of pain management and pain management practices. The intervention offered is education and skills training. The study has a pre-post design and a comparison group. Data is collected before the intervention is started (baseline T1) and again one month (T2) and six months (T3) after the intervention. Nurses working in six postoperative units are participating. The units are the largest pediatric postoperative units of each of the six university hospitals covering all health regions in Norway. Three different approaches will be used to collect data (survey with questionnaire, observations of clinical practice, and interviews with children).

Description:

The study will explore the nurses' pediatric postoperative pain management knowledge and clinical practice, and evaluate if a tailored educational intervention will improve postoperative pain management practice. This will be achieved by first exploring the pediatric postoperative pain management practice using different approaches (study 1). Then, an intervention will be developed based on the results from the first study and available research in the area (study 2). Finally, the investigators will investigate if the tailored interventions with nurses at postoperative units improve the nurses' knowledge of pediatric pain management (study 3).

Studies Activity:

Study 1: Explore nurses' pediatric postoperative pain practices.

Data collection (baseline T1):

• Knowledge and attitudes (questionnaire PNKAS-N)

• Observational study of nurses clinical practice

• Interview with children about pain and pain management after surgery

Study 2: Develop a tailored educational intervention

• Literature review

• Results from baseline

• Feedback from the head of the relevant units

• Staff views about the facilitators and barriers to optimized pediatric pain management

Study 3: Implementation and evaluation of the intervention

The intervention:

• Lectures and workshops for the included nurses

• Clinical supervision of the nurses

Data collection (one months after the intervention (T2), and six months after the intervention (T3))

• Questionnaire PNKAS-N (T2 and T3)

• Observational study of clinical practice (T2 and T3)

• Interview with children (T2)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 876
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Survey:

• nurses working in six postoperative units for children in six university hospitals in Norway

Observational study of clinical practice:

• nurses working in six postoperative units for children in six university hospitals in Norway

• children (0-18 years) and their parents admitted to these six postoperative units for children in six university hospitals in Norway during the data collection period

Interview with children:

• children older than six years going through surgery at the time of data collection at two of six units (randomly chosen), and their parents, will be asked to participate in this study

Exclusion Criteria:

Survey and Observational study of clinical practice:

• nurses not involved in clinical work

• nurses working part-time (less than 75%)

Interview with children:

• children not admitted to the postoperative units

• children younger than 6 years of age

Related Conditions & MeSH terms

• Pain, Postoperative
• Pediatric ALL
• Postoperative Pain

Intervention

Other:
• Tailored Educational Intervention
The intervention will be a one-day seminar for nurses working at the units, with lectures and workshops with main focus on the subjects showing the lowest pediatric pain management competence. In addition, there will be clinical supervision in pediatric postoperative pain management (two or three days per unit). The intervention will be conducted by two experts (nurse and physician) in pediatric postoperative pain management. After the intervention there will be different reminders every week for the first month, and then every month (in different forms) about pediatric pain management during six months of time.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Akershus University hospital	Lillestrøm
Norway	Oslo University Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olavs hospital Trondheim University Hospital	Trondheim

Sponsors (12)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Helse Stavanger HF, Karolinska University Hospital, London South Bank University, Norwegian Nurses Organisation, Oslo Metropolitan University, South-Eastern Norway Regional Health Authority, St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nurses' knowledge and attitudes of pediatric pain management	Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N). Scale ranges from minimum 0 to maximum 40.	short term - three months after baseline (one month after intervention) and long term - eight months after baseline (six months after intervention)
Secondary	Nurses pediatric pain management practices in postoperative units	Evaluated with non-participant observation using a structured observational tool (checklist) and field notes	baseline - after surgery (observing for two weeks in each unit)
Secondary	Changes in nurses' pediatric pain management practices in postoperative units	Evaluated with non-participant observation using a structured observational tool (checklist) and field notes	short term - three months after baseline (one month after intervention)
Secondary	Changes in nurses' pediatric pain management practices in postoperative units	Evaluated with non-participant observation using a structured observational tool (checklist) and field notes	long term - eight months after baseline (six months after intervention)
Secondary	Children's experiences of pain and pain management after surgery	Measured with Interview with children about postoperative pain using semi-structured interviews with children after surgery	baseline - after surgery
Secondary	Changes in children's experiences of pain and pain management after surgery	Evaluated with Interview with children about postoperative pain using semi-structured interviews with children after surgery	One month after intervention