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Pediatric Pain Management - an Intervention Study

Primary Purpose

Postoperative Pain, Pediatric ALL

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tailored Educational Intervention
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring pediatric pain, postoperative pain, pain assessment, pain management, knowledge, children, nurses

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital
  • Akershus University hospital
  • Oslo University Hospital
  • Stavanger University Hospital
  • University Hospital of North Norway
  • St. Olavs hospital Trondheim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nurses pediatric pain management practices in postoperative units
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Changes in nurses' pediatric pain management practices in postoperative units
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Changes in nurses' pediatric pain management practices in postoperative units
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
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
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

Full Information

First Posted
October 30, 2017
Last Updated
February 22, 2023
Sponsor
Oslo University Hospital
Collaborators
Norwegian Nurses Organisation, South-Eastern Norway Regional Health Authority, London South Bank University, Karolinska University Hospital, Oslo Metropolitan University, University of Oslo, University Hospital, Akershus, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03385681
Brief Title
Pediatric Pain Management - an Intervention Study
Official Title
Pediatric Pain Management in Post Anesthesia Care Units - an Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Nurses Organisation, South-Eastern Norway Regional Health Authority, London South Bank University, Karolinska University Hospital, Oslo Metropolitan University, University of Oslo, University Hospital, Akershus, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Pediatric ALL
Keywords
pediatric pain, postoperative pain, pain assessment, pain management, knowledge, children, nurses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallell groups- intervention and control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
876 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tailored Educational Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in nurses' knowledge and attitudes of pediatric pain management
Description
Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N). Scale ranges from minimum 0 to maximum 40.
Time Frame
short term - three months after baseline (one month after intervention) and long term - eight months after baseline (six months after intervention)
Secondary Outcome Measure Information:
Title
Nurses pediatric pain management practices in postoperative units
Description
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Time Frame
baseline - after surgery (observing for two weeks in each unit)
Title
Changes in nurses' pediatric pain management practices in postoperative units
Description
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Time Frame
short term - three months after baseline (one month after intervention)
Title
Changes in nurses' pediatric pain management practices in postoperative units
Description
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Time Frame
long term - eight months after baseline (six months after intervention)
Title
Children's experiences of pain and pain management after surgery
Description
Measured with Interview with children about postoperative pain using semi-structured interviews with children after surgery
Time Frame
baseline - after surgery
Title
Changes in children's experiences of pain and pain management after surgery
Description
Evaluated with Interview with children about postoperative pain using semi-structured interviews with children after surgery
Time Frame
One month after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tone Rustoen, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Akershus University hospital
City
Lillestrøm
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
St. Olavs hospital Trondheim University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Pediatric Pain Management - an Intervention Study

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