Pediatric Pain Management - an Intervention Study

February 22, 2023 updated by: Tone Rustøen, Oslo University Hospital

Pediatric Pain Management in Post Anesthesia Care Units - an Intervention Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
876

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Lillestrøm, Norway
        • Akershus University Hospital
      • Oslo, Norway
        • Oslo University Hospital
      • Stavanger, Norway
        • Stavanger University Hospital
      • Tromsø, Norway
        • University Hospital of North Norway
      • Trondheim, Norway
        • St. Olavs Hospital Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in nurses' knowledge and attitudes of pediatric pain management
Time Frame: short term - three months after baseline (one month after intervention) and long term - eight months after baseline (six months after intervention)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nurses pediatric pain management practices in postoperative units
Time Frame: baseline - after surgery (observing for two weeks in each unit)
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
baseline - after surgery (observing for two weeks in each unit)
Changes in nurses' pediatric pain management practices in postoperative units
Time Frame: short term - three months after baseline (one month after intervention)
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
short term - three months after baseline (one month after intervention)
Changes in nurses' pediatric pain management practices in postoperative units
Time Frame: long term - eight months after baseline (six months after intervention)
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
long term - eight months after baseline (six months after intervention)
Children's experiences of pain and pain management after surgery
Time Frame: baseline - after surgery
Measured with Interview with children about postoperative pain using semi-structured interviews with children after surgery
baseline - after surgery
Changes in children's experiences of pain and pain management after surgery
Time Frame: One month after intervention
Evaluated with Interview with children about postoperative pain using semi-structured interviews with children after surgery
One month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Karolinska University Hospital
University Hospital of North Norway
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital, Akershus
Norwegian Nurses Organisation
South-Eastern Norway Regional Health Authority
Oslo Metropolitan University
London South Bank University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tone Rustoen, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/7951
  • 2014/878 (Other Identifier: Regional Committee for Medical Research Ethics Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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