EducationNCT05373641
Effect of Repeated Feedback to Registered Nurses Pain Nursing Documentation
A study testing Repeated feedback and Pain documentation audit in people with Education and Nurse's Role, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Education, Nurse's Role, Pain
- What is being tested?
- Repeated feedback and Pain documentation audit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 4 Mar 2022to 31 Dec 2022
- 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
- Registered nurses (RN) who work at the Kuopio University Hospital in units of which patients potentially require pain management.
Who cannot join
- Professionals other than RN
- RN who do not use pain management strategies in their work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Repeated Feedback to RNs' Pain Nursing Documentation: A Cluster Randomized Trial
The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. In addition, how background variables are related to the pain nursing documentation.
Research hypothesis:
Pain nursing documentation audit and educational feedback increased RNs' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.
- Conditions
- Education, Nurse's Role, Pain
- Being tested
- Repeated feedback, Pain documentation audit
- Keywords
- RN, Pain nursing, Pain assessment, Pain management, Pain documentation, Audit and feedback, Education, Randomized Controlled Trial, Nursing sensitive quality, Nursing sensitive outcomes
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated feedbackOther
Repeated feedback monthly based on previous month pain documentation audit results.
Pain documentation auditOther
Monthly pain documentation audit
| Study group | Role | What they receive |
|---|---|---|
| Pain documentation audit and repeated feedback | Experimental | Pain documentation audit and repeted feedback Receives: Other: Repeated feedback; Other: Pain documentation audit |
| Pain documentation audit | Active comparator | Pain documentation audit Receives: Other: Pain documentation audit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RNs' pain documentation
MEASUREMENT TOOL: Structured audit frame to evaluate pain assessment and management documentation.
UNIT OF MEASURE:
Information is collected as follows from EHR
- Patient pain documented in the care chart
- Patient need for pain management documented
- Patient pain management goal documented
- Patient pain assessment
- Patient pain assessment in the previous 24 hours
- Patient pain
- Use of pain assessment tool
- Non-pharmacological methods
- Pharmacological interventions
- Intervention (pharmacological or non-pharmacological effect assessment)
Multiple measurements are aggregated to achieve one declared value as follows:
First, each evaluated area results in 0 (not fulfilled) or 1 point (fulfilled). Second, the points are summed. Third, the sum is transformed to a 0-100 scale and reported as a single value reflecting pain documentation quality.
Measured: Baseline (T0), month 1 (T1), month 2 (T2), month 3 (T3), month 4 (T4), month 5 (T5) month 6 (T6), month 7 (T7), month 8 (T8)
Change in RNs' pain knowledge
Pain knowledge questionnaire used in three time points
Measured: Baseline (T0), month 3 (T3), month (T7)
Secondary outcomes (2)
Change in patient satisfaction of pain management
Nursing patient feedback questionnaire analyzed at two time points
Measured: Before intervention (T0), month 3 (T3), month 6 (T6), month 8 (T8)
Change in number of pain nursing incident reports
Pain nursing incident reports analyzed at two time points
Measured: Before intervention (T0), month 8 (T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start4 Mar 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Units serve as a statistical units. Number of units 30, number of individual participants 800-1000.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373641
- Sponsor's protocol ID
- 50UL015
- Status last verified
- Nov 2022
- First submitted
- 22 Feb 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grommi S, Voutilainen A, Vaajoki A, Kankkunen P. Effects of Repeated Feedback on Pain Documentation: A Cluster Randomized Trial. Pain Manag Nurs. 2025 Jun;26(3):336-343. doi: 10.1016/j.pmn.2024.12.021. Epub 2025 Jan 30.
PubMed 39890564
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Feedback to RNs' Pain Nursing Documentation: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05373641
- Acronym / sponsor ID
- 50UL015
- Conditions
- Education, Nurse's Role, Pain
- Keywords
- RN, Pain nursing, Pain assessment, Pain management, Pain documentation, Audit and feedback, Education, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 May 2022 (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.
The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. In addition, how background variables are related to the pain nursing documentation.
Research hypothesis:
Pain nursing documentation audit and educational feedback increased RNs' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Units serve as a statistical units. Number of units 30, number of individual participants 800-1000.
| Arm | Type | Receives |
|---|---|---|
| Pain documentation audit and repeated feedback | Experimental | Other: Repeated feedback, Other: Pain documentation auditPain documentation audit and repeted feedback |
| Pain documentation audit | Active comparator | Other: Pain documentation auditPain documentation audit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered nurses (RN) who work at the Kuopio University Hospital in units of which patients potentially require pain management.
Key exclusion criteria (2 listed)
- Professionals other than RN
- RN who do not use pain management strategies in their work
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 |
|---|---|---|
| Repeated feedbackRepeated feedback monthly based on previous month pain documentation audit results. | Other | Pain documentation audit and repeated feedback |
| Pain documentation auditMonthly pain documentation audit | Other | Pain documentation audit, Pain documentation audit and repeated feedback |
Primary outcome
Change in RNs' pain documentation
Time frame: Baseline (T0), month 1 (T1), month 2 (T2), month 3 (T3), month 4 (T4), month 5 (T5) month 6 (T6), month 7 (T7), month 8 (T8)
MEASUREMENT TOOL: Structured audit frame to evaluate pain assessment and management documentation. UNIT OF MEASURE: Information is collected as follows from EHR 1. Patient pain documented in the care chart 2. Patient need for pain management documented 3. Patient pain management goal documented 4. Patient pain assessment 5. Patient pain assessment in the previous 24 hours 6. Patient pain 7. Use of pain assessment tool 8. Non-pharmacological methods 9. Pharmacological interventions 10. Intervention (pharmacological or non-pharmacological effect assessment) Multiple measurements are aggregated to achieve one declared value as follows: First, each evaluated area results in 0 (not fulfilled) or 1 point (fulfilled). Second, the points are summed. Third, the sum is transformed to a 0-100 scale and reported as a single value reflecting pain documentation quality.
Change in RNs' pain knowledge
Time frame: Baseline (T0), month 3 (T3), month (T7)
Pain knowledge questionnaire used in three time points
2 secondary outcomes
Change in patient satisfaction of pain management
Time frame: Before intervention (T0), month 3 (T3), month 6 (T6), month 8 (T8)
Change in number of pain nursing incident reports
Time frame: Before intervention (T0), month 8 (T8)
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 25 Oct 2023.
- Derived from this study: PubMed 39890564Grommi S, Voutilainen A, Vaajoki A, Kankkunen P. Effects of Repeated Feedback on Pain Documentation: A Cluster Randomized Trial. Pain Manag Nurs. 2025 Jun;26(3):336-343. doi: 10.1016/j.pmn.2024.12.021. Epub 2025 Jan 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated feedback and Pain documentation audit in people with Education and Nurse's Role, run by Kuopio University Hospital at 1 site in Finland.
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 1 inclusion and 2 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 25 Oct 2023. 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 Finland. 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?
Change in RNs' pain documentation (time frame: Baseline (T0), month 1 (T1), month 2 (T2), month 3 (T3), month 4 (T4), month 5 (T5) month 6 (T6), month 7 (T7), month 8 (T8)). 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?
On the ClinicalTrials.gov record for NCT05373641, which also lists 1 linked publication.
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 25 Oct 2023.