Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

Postoperative Pain Clinical Trial

Official title:

Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03987399
• Other study ID #: 2019/388
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 650
• Est. completion date: December 31, 2026
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Karolinska University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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