Pediatric Pain Management - an Intervention Study

NCT ID: NCT03385681

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallell groups- intervention and control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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.

Group Type EXPERIMENTAL

Tailored Educational Intervention

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tailored Educational Intervention

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 Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian Nurses Organisation

OTHER

Sponsor Role collaborator

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

London South Bank University

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tone Rustøen

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tone Rustoen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haukeland University Hospital

Bergen, , Norway

Site Status

Akershus University hospital

Lillestrøm, , Norway

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

St. Olavs hospital Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014/878

Identifier Type: OTHER

Identifier Source: secondary_id

2014/7951

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.