Pediatric Pain Management - an Intervention Study

NCT03385681 | Completed

• 2 other identifiers: 2014/79512014/878
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 6

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).

Conditions

Postoperative Pain; Pediatric ALL

Keywords

pediatric pain; postoperative pain; pain assessment; pain management; knowledge; children; nurses

Outcome Measures

Primary Outcomes (1)

• 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.

  short term - three months after baseline (one month after intervention) and long term - eight months after baseline (six months after intervention)

Secondary Outcomes (5)

• Nurses pediatric pain management practices in postoperative units

  baseline - after surgery (observing for two weeks in each unit)

• Changes in nurses' pediatric pain management practices in postoperative units

  short term - three months after baseline (one month after intervention)

• Changes in nurses' pediatric pain management practices in postoperative units

  long term - eight months after baseline (six months after intervention)

• Children's experiences of pain and pain management after surgery

  baseline - after surgery

• Changes in children's experiences of pain and pain management after surgery

  One month after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Tailored Educational Intervention

Control Group

NO INTERVENTION

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.

Interventions

Tailored Educational Intervention OTHER

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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Nurses Organisation: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• London South Bank University: collaborator
• Karolinska University Hospital: collaborator
• Oslo Metropolitan University: collaborator
• University of Oslo: collaborator
• University Hospital, Akershus: collaborator
• Helse Stavanger HF: collaborator
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (6)

Haukeland University Hospital

Bergen, Norway

Location

Akershus University hospital

Lillestrøm, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St. Olavs hospital Trondheim University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Tone Rustoen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Two parallell groups- intervention and control

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 28, 2017
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)