Postoperative PainNCT03385681
Pediatric Pain Management - an Intervention Study
A study testing Tailored Educational Intervention in people with Postoperative Pain and Pediatric ALL, run by Oslo University Hospital at 6 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Pediatric ALL
- What is being tested?
- Tailored Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 6 sitesNorway
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Haukeland University Hospital
Bergen
Akershus University hospital
Lillestrøm
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
University Hospital of North Norway
Tromsø
St. Olavs hospital Trondheim University Hospital
Trondheim
About this study
Official title: 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).
Read the 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)
- Conditions
- Postoperative Pain, Pediatric ALL
- Being tested
- Tailored Educational Intervention
- Keywords
- pediatric pain, postoperative pain, pain assessment, pain management, knowledge, children, nurses
- Medical subject headings
- Pain, Postoperative, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Educational InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Measured: baseline - after surgery (observing for two weeks in each unit)
Changes in nurses' pediatric pain management practices in postoperative units
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Measured: short term - three months after baseline (one month after intervention)
Changes in nurses' pediatric pain management practices in postoperative units
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Measured: long term - eight months after baseline (six months after intervention)
Children's experiences of pain and pain management after surgery
Measured with Interview with children about postoperative pain using semi-structured interviews with children after surgery
Measured: baseline - after surgery
Changes in children's experiences of pain and pain management after surgery
Evaluated with Interview with children about postoperative pain using semi-structured interviews with children after surgery
Measured: One month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallell groups- intervention and control
- Masking
- None (open label)
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Nurses Organisation, South-Eastern Norway Regional Health Authority, London South Bank University, Karolinska University Hospital, Oslo Metropolitan University, University of Oslo, University Hospital, Akershus, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustoen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385681
- Sponsor's protocol ID
- 2014/7951
- Other IDs
- 2014/878
- Status last verified
- Feb 2023
- First submitted
- 30 Oct 2017
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Pain Management in Post Anesthesia Care Units - an Intervention Study
- ClinicalTrials.gov ID
- NCT03385681
- Acronym / sponsor ID
- 2014/7951
- Conditions
- Postoperative Pain, Pediatric ALL
- Keywords
- pediatric pain, postoperative pain, pain assessment, pain management, knowledge, children, nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Nurses Organisation, South-Eastern Norway Regional Health Authority, London South Bank University, Karolinska University Hospital, Oslo Metropolitan University, University of Oslo, University Hospital, Akershus, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallell groups- intervention and control
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Tailored Educational InterventionThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- nurses working in six postoperative units for children in six university hospitals in Norway
- 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
- 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
Key exclusion criteria (6 listed)
- nurses not involved in clinical work
- nurses working part-time (less than 75%)
- children not admitted to the postoperative units
- children younger than 6 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Educational InterventionThe 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. | Other | Intervention Group |
Primary outcome
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.
5 secondary outcomes
Nurses pediatric pain management practices in postoperative units
Time frame: 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)
Changes in nurses' pediatric pain management practices in postoperative units
Time frame: 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
Changes in children's experiences of pain and pain management after surgery
Time frame: One month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone Rustoen, PhD principal investigator
Oslo University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Educational Intervention in people with Postoperative Pain and Pediatric ALL, run by Oslo University Hospital at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.