Clinical trial NCT03385681: Pediatric Pain Management - an Intervention Study
Official title: Pediatric Pain Management in Post Anesthesia Care Units - an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Pediatric ALL
Keywords: pediatric pain
postoperative pain
pain assessment
pain management
knowledge
children
nurses
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Nurses Organisation
name: South-Eastern Norway Regional Health Authority
name: London South Bank University
name: Karolinska University Hospital
name: Oslo Metropolitan University
name: University of Oslo
name: University Hospital, Akershus
name: Helse Stavanger HF
name: Haukeland University Hospital
name: St. Olavs Hospital
name: University Hospital of North Norway
First posted: 2017-12-28
Enrollment: 876
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallell groups- intervention and control
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Changes in nurses' knowledge and attitudes of pediatric pain management
timeFrame: short term - three months after baseline (one month after intervention) and long term - eight months after baseline (six months after intervention)
Secondary outcomes:
measure: Nurses pediatric pain management practices in postoperative units
timeFrame: baseline - after surgery (observing for two weeks in each unit)
measure: Changes in nurses' pediatric pain management practices in postoperative units
timeFrame: short term - three months after baseline (one month after intervention)
measure: Changes in nurses' pediatric pain management practices in postoperative units
timeFrame: long term - eight months after baseline (six months after intervention)
measure: Children's experiences of pain and pain management after surgery
timeFrame: baseline - after surgery
measure: Changes in children's experiences of pain and pain management after surgery
timeFrame: One month after intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Lillestrøm
country: Norway
facility: Akershus University hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs hospital Trondheim University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustoen, PhD
role: PRINCIPAL_INVESTIGATOR
References: