Pediatric Pain Management - an Intervention Study

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Pediatric ALL
• Intervention / Treatment: Other: Tailored Educational Intervention

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 876
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Lillestrøm, Norway
    • Akershus University Hospital
  • Oslo, Norway
    • Oslo University Hospital
  • Stavanger, Norway
    • Stavanger University Hospital
  • Tromsø, Norway
    • University Hospital of North Norway
  • Trondheim, Norway
    • St. Olavs Hospital Trondheim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The study will be conducted by nurses at 3 postoperative units with children and adolescents after surgery. All nurses working with patients in these units will be asked to participate. Tailored Educational Intervention is administered to this group.	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.
No Intervention: Control Group; The study will be conducted by nurses at 3 postoperative units with children and adolescents after surgery. All nurses working with patients in these units will be asked to participate in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Karolinska University Hospital; University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; St. Olavs Hospital; University Hospital, Akershus; Norwegian Nurses Organisation; South-Eastern Norway Regional Health Authority; Oslo Metropolitan University; London South Bank University
• Investigators: Principal Investigator: Tone Rustoen, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: children; pain assessment; postoperative pain; nurses; knowledge; pain management; pediatric pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2014/7951; 2014/878 (Other Identifier: Regional Committee for Medical Research Ethics Norway)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No