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Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

Primary Purpose

Postoperative Pain

Status
Active
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, healthcare providers, children, nurses, physicians, tailored educational intervention, surgical wards

Eligibility Criteria

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

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)

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailored educational intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Nurses' pediatric postoperative pain management practices in surgical wards
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
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
Children's experiences of pain and pain management after surgery
Evaluated using semi-structured face-to-face interviews with children after surgery
Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management
Evaluated using semi-structured focus group interviews with healthcare providers

Full Information

First Posted
June 12, 2019
Last Updated
May 10, 2022
Sponsor
Oslo University Hospital
Collaborators
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03987399
Brief Title
Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study
Official Title
Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Karolinska University Hospital

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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pediatric pain, postoperative pain, pain assessment, pain management, healthcare providers, children, nurses, physicians, tailored educational intervention, surgical wards

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tailored educational intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tailored educational intervention
Intervention Description
Educational day (lecture and workshop), clinical supervision and reminders
Primary Outcome Measure Information:
Title
Healthcare providers' knowledge and attitudes of pediatric pain management
Description
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).
Time Frame
Baseline
Title
Changes in Healthcare providers' knowledge and attitudes of pediatric pain management
Description
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).
Time Frame
short term - one month after intervention and long term - six and 12 months after intervention
Secondary Outcome Measure Information:
Title
Nurses' pediatric postoperative pain management practices in surgical wards
Description
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Time Frame
Baseline
Title
Changes in nurses' pediatric postoperative pain management practices in surgical wards
Description
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Time Frame
short term - one month after intervention and long term - six and 12 months after intervention
Title
Children's experiences of pain and pain management after surgery
Description
Evaluated using semi-structured face-to-face interviews with children after surgery
Time Frame
Baseline
Title
Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management
Description
Evaluated using semi-structured focus group interviews with healthcare providers
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten C Moe, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

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