Postoperative PainNCT03987399
Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study
A study testing Tailored educational intervention in people with Postoperative Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study will explore healthcare providers' pediatric postoperative pain management knowledge and clinical practice. The aim of this study is to explore healthcare providers' knowledge and clinical practice in pediatric postoperative pain management in surgical wards, and to evaluate whether an educational… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Tailored educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteNorway
- Study dates
- 8 Apr 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- nurses working at all four wards and all surgeons (experienced) at the corresponding wards
- nurses working in all four wards
- children (0-18 years) admitted to these wards during the data collection period, and their parents
- Interview with children
- children (6-18 years) going through surgery at all four wards during the data collection period, and their parents
- healthcare providers working in the four wards (two to four nurses, two surgeons, and two anesthesiologists in each group)
Who cannot join
- nurses not involved in clinical work
- Observational study
- children with cognitive impairment who were unable to communicate verbally
- children who did not speak Norwegian
- children younger than six years
- Interview with healthcare providers
Trial locations and contacts
1 site in 1 country.
About this study
This study will explore healthcare providers' pediatric postoperative pain management knowledge and clinical practice. The aim of this study is to explore healthcare providers' knowledge and clinical practice in pediatric postoperative pain management in surgical wards, and to evaluate whether an educational intervention would improve postoperative pain management. This study has a pre-post intervention design. This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.
Read the detailed description
This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.
To get a broader view of barriers and facilitators for effective pediatric postoperative pain management, there will be carried out focus group interviews with healthcare providers. Further, data about healthcare providers' knowledge and attitudes regarding pediatric pain will be collected using a questionnaire. Data about nurses' pediatric postoperative pain management will be collected using non-participant observational study and data about children's experience about pain and pain management will be collected using face-to-face interviews with children. This study will have different phases:
Phase 1 Explore healthcare providers' knowledge, clinical practice children's experiences of pain and pain management, and healthcare providers' experiences of barriers and facilitators for effective pain management
- Questionnaire PNKAS-N
- Observation of clinical practice
- Face-to-face interviews with children
- Focus group interviews with healthcare providers (barriers and facilitators)
Phase 2 Develop and implement a tailored educational intervention
Develop tailored educational intervention based on:
- Available research
- Results from baseline
- Feedback from head of the relevant units
- Staff views about the facilitators and barriers to optimized pediatric pain management
Implementation of the intervention
- Seminar (lecture and workshop)
- Clinical supervision
- Reminders
Phase 3 Evaluation of the intervention
- Questionnaire PNKAS-N
- Observation of clinical practice
- Conditions
- Postoperative Pain
- Being tested
- Tailored educational intervention
- Keywords
- pediatric pain, postoperative pain, pain assessment, pain management, healthcare providers, children, nurses, physicians, tailored educational intervention, surgical wards
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored educational interventionOther
Educational day (lecture and workshop), clinical supervision and reminders
| Study group | Role | What they receive |
|---|---|---|
| Tailored educational intervention | Experimental | The intervention will be based on previous research and results from baseline (T1). The intervention will be a one-day educational day and includes lectures and workshops with main focus on the lowest competence in pediatric postoperative pain management. Healthcare providers at the included surgical wards will be invited to participate on this educational day. As a supplement, there will be provided clinical supervision in pediatric postoperative pain management and reminders (such as lectures and posters) over a period of six months after educational day. Receives: Other: Tailored educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare providers' knowledge and attitudes of pediatric pain management
Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N).The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).
Measured: Baseline
Changes in Healthcare providers' knowledge and attitudes of pediatric pain management
Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N). The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).
Measured: short term - one month after intervention and long term - six and 12 months after intervention
Secondary outcomes (4)
Nurses' pediatric postoperative pain management practices in surgical wards
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Measured: Baseline
Changes in nurses' pediatric postoperative pain management practices in surgical wards
Evaluated with non-participant observation using a structured observational tool (checklist) and field notes
Measured: short term - one month after intervention and long term - six and 12 months after intervention
Children's experiences of pain and pain management after surgery
Evaluated using semi-structured face-to-face interviews with children after surgery
Measured: Baseline
Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management
Evaluated using semi-structured focus group interviews with healthcare providers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start8 Apr 2019
- Primary completion1 Dec 2020
- Study completion31 Dec 2026 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Anja Hetland Smeland, Oslo University Hospital
- Investigators
- Morten C Moe, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987399
- Sponsor's protocol ID
- 2019/388
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2019
- Last updated
- 18 Mar 2025
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Postoperative Pain Management in Surgical Wards - an Intervention Study
- ClinicalTrials.gov ID
- NCT03987399
- Acronym / sponsor ID
- 2019/388
- Conditions
- Postoperative Pain
- Keywords
- pediatric pain, postoperative pain, pain assessment, pain management, healthcare providers, children, nurses, physicians
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2019 (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 healthcare providers' pediatric postoperative pain management knowledge and clinical practice. The aim of this study is to explore healthcare providers' knowledge and clinical practice in pediatric postoperative pain management in surgical wards, and to evaluate whether an educational intervention would improve postoperative pain management. This study has a pre-post intervention design. This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.
Detailed description
This study will be conducted on four surgical wards in one university hospital in Norway. There will be used different methodological approaches for data collections (interviews, questionnaire, observational study) with four measurement points; baseline (T1), and one month (T2), six months (T3) and 12 months (T4) after intervention.
To get a broader view of barriers and facilitators for effective pediatric postoperative pain management, there will be carried out focus group interviews with healthcare providers. Further, data about healthcare providers' knowledge and attitudes regarding pediatric pain will be collected using a questionnaire. Data about nurses' pediatric postoperative pain management will be collected using non-participant observational study and data about children's experience about pain and pain management will be collected using face-to-face interviews with children. This study will have different phases:
Phase 1 Explore healthcare providers' knowledge, clinical practice children's experiences of pain and pain management, and healthcare providers' experiences of barriers and facilitators for effective pain management
- Questionnaire PNKAS-N
- Observation of clinical practice
- Face-to-face interviews with children
- Focus group interviews with healthcare providers (barriers and facilitators)
Phase 2 Develop and implement a tailored educational intervention
Develop tailored educational intervention based on:
- Available research
- Results from baseline
- Feedback from head of the relevant units
- Staff views about the facilitators and barriers to optimized pediatric pain management
Implementation of the intervention
- Seminar (lecture and workshop)
- Clinical supervision
- Reminders
Phase 3 Evaluation of the intervention
- Questionnaire PNKAS-N
- Observation of clinical practice
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored educational intervention | Experimental | Other: Tailored educational interventionThe intervention will be based on previous research and results from baseline (T1). The intervention will be a one-day educational day and includes lectures and workshops with main focus on the lowest competence in pediatric postoperative pain management. Healthcare providers at the included surgical wards will be invited to participate on this educational day. As a supplement, there will be provided clinical supervision in pediatric postoperative pain management and reminders (such as lectures and posters) over a period of six months after educational day. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- nurses working at all four wards and all surgeons (experienced) at the corresponding wards
- nurses working in all four wards
- children (0-18 years) admitted to these wards during the data collection period, and their parents
- Interview with children
- children (6-18 years) going through surgery at all four wards during the data collection period, and their parents
Key exclusion criteria (6 listed)
- nurses not involved in clinical work
- Observational study
- children with cognitive impairment who were unable to communicate verbally
- children who did not speak Norwegian
- children younger than six years
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 interventionEducational day (lecture and workshop), clinical supervision and reminders | Other | Tailored educational intervention |
Primary outcome
Healthcare providers' knowledge and attitudes of pediatric pain management
Time frame: Baseline
Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N).The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).
Changes in Healthcare providers' knowledge and attitudes of pediatric pain management
Time frame: short term - one month after intervention and long term - six and 12 months after intervention
Evaluated with "The Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain Questionnaire - Norwegian version" (PNKAS-N). The questionnaire consists of 36 questions with a total score of 36. The scale ranges from minimum 0 to maximum 36 (best score).
4 secondary outcomes
Nurses' pediatric postoperative pain management practices in surgical wards
Time frame: Baseline
Changes in nurses' pediatric postoperative pain management practices in surgical wards
Time frame: short term - one month after intervention and long term - six and 12 months after intervention
Children's experiences of pain and pain management after surgery
Time frame: Baseline
Healthcare providers experience barriers and facilitators for effective pediatric postoperative pain management
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Morten C Moe, PhD principal investigator
Oslo University Hospital
1 site 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, run by Oslo University Hospital at 1 site 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 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Healthcare providers' knowledge and attitudes of pediatric pain management (time frame: Baseline). The study lists 2 primary outcomes in all. 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 18 Mar 2025.