Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

This study will explore healthcare providers' pediatric postoperative pain management knowledge and clinical practice. The aim of this study is to explore healthcare providers' knowledge and clinical practice in pediatric postoperative pain management in surgical wards, and to evaluate whether an educational intervention would improve postoperative pain management. This study has a pre-post intervention design. This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Tailored educational intervention

Detailed Description

This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.

To get a broader view of barriers and facilitators for effective pediatric postoperative pain management, there will be carried out focus group interviews with healthcare providers. Further, data about healthcare providers' knowledge and attitudes regarding pediatric pain will be collected using a questionnaire. Data about nurses' pediatric postoperative pain management will be collected using non-participant observational study and data about children's experience about pain and pain management will be collected using face-to-face interviews with children. This study will have different phases:

Phase 1 Explore healthcare providers' knowledge, clinical practice children's experiences of pain and pain management, and healthcare providers' experiences of barriers and facilitators for effective pain management

• Questionnaire PNKAS-N
• Observation of clinical practice
• Face-to-face interviews with children
• Focus group interviews with healthcare providers (barriers and facilitators)

Phase 2 Develop and implement a tailored educational intervention

Develop tailored educational intervention based on:

• Available research
• Results from baseline
• Feedback from head of the relevant units
• Staff views about the facilitators and barriers to optimized pediatric pain management

Implementation of the intervention

• Seminar (lecture and workshop)
• Clinical supervision
• Reminders

Phase 3 Evaluation of the intervention

• Questionnaire PNKAS-N
• Observation of clinical practice

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Questionnaire

Inclusion Criteria:

• nurses working at all four wards and all surgeons (experienced) at the corresponding wards

Exclusion Criteria:

• nurses not involved in clinical work

Observational study

Inclusion Criteria:

• nurses working in all four wards
• children (0-18 years) admitted to these wards during the data collection period, and their parents

Interview with children

Inclusion Criteria:

• children (6-18 years) going through surgery at all four wards during the data collection period, and their parents

Exclusion Criteria:

• children with cognitive impairment who were unable to communicate verbally
• children who did not speak Norwegian
• children younger than six years

Interview with healthcare providers

Inclusion Criteria:

• healthcare providers working in the four wards (two to four nurses, two surgeons, and two anesthesiologists in each group)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tailored educational intervention; The intervention will be based on previous research and results from baseline (T1). The intervention will be a one-day educational day and includes lectures and workshops with main focus on the lowest competence in pediatric postoperative pain management. Healthcare providers at the included surgical wards will be invited to participate on this educational day. As a supplement, there will be provided clinical supervision in pediatric postoperative pain management and reminders (such as lectures and posters) over a period of six months after educational day.

Other: Tailored educational intervention; Educational day (lecture and workshop), clinical supervision and reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare providers' knowledge and attitudes of pediatric pain management	Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N).The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).	Baseline
Changes in Healthcare providers' knowledge and attitudes of pediatric pain management	Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N). The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).	short term - one month after intervention and long term - six and 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurses' pediatric postoperative pain management practices in surgical wards	Evaluated with non-participant observation using a structured observational tool (checklist) and field notes	Baseline
Changes in nurses' pediatric postoperative pain management practices in surgical wards	Evaluated with non-participant observation using a structured observational tool (checklist) and field notes	short term - one month after intervention and long term - six and 12 months after intervention
Children's experiences of pain and pain management after surgery	Evaluated using semi-structured face-to-face interviews with children after surgery	Baseline
Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management	Evaluated using semi-structured focus group interviews with healthcare providers	Baseline

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Morten C Moe, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: children; pain assessment; postoperative pain; nurses; pain management; pediatric pain; physicians; healthcare providers; tailored educational intervention; surgical wards
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 2019/388

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