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Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

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ClinicalTrials.gov Identifier: NCT03987399
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Anja Hetland Smeland, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Other: Tailored educational intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Healthcare providers' knowledge and attitudes of pediatric pain management [ Time Frame: Baseline ]
    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).

  2. Changes in Healthcare providers' knowledge and attitudes of pediatric pain management [ Time Frame: short term - one month after intervention and long term - six and 12 months after intervention ]
    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 :
  1. Nurses' pediatric postoperative pain management practices in surgical wards [ Time Frame: Baseline ]
    Evaluated with non-participant observation using a structured observational tool (checklist) and field notes

  2. Changes in nurses' pediatric postoperative pain management practices in surgical wards [ Time Frame: short term - one month after intervention and long term - six and 12 months after intervention ]
    Evaluated with non-participant observation using a structured observational tool (checklist) and field notes

  3. Children's experiences of pain and pain management after surgery [ Time Frame: Baseline ]
    Evaluated using semi-structured face-to-face interviews with children after surgery

  4. Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management [ Time Frame: Baseline ]
    Evaluated using semi-structured focus group interviews with healthcare providers



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987399


Contacts
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Contact: Morten C Moe, PhD +4741806401 ext +4741806401 cmoe@klinmed.uio.no
Contact: Anja H Smeland, MSc +47 93015102 ext +4741806401 cmoe@klinmed.uio.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Morten Moe, PhD    +47 41806401    cmoe@klinmed.uio.no   
Contact: Anja Smeland, MSc    +47 93015102    anjsme@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Karolinska University Hospital
Investigators
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Principal Investigator: Morten C Moe, PhD Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Anja Hetland Smeland, Oslo University Hospital:
Study Protocol  [PDF] April 30, 2019
Statistical Analysis Plan  [PDF] April 30, 2019


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Responsible Party: Anja Hetland Smeland, Research nurse, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03987399     History of Changes
Other Study ID Numbers: 2019/388
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anja Hetland Smeland, Oslo University Hospital:
pediatric pain
postoperative pain
pain assessment
pain management
healthcare providers
children
nurses
physicians
tailored educational intervention
surgical wards

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms