Pediatric Pain EducationNCT07735299
Jigsaw Cooperative Learning for Pediatric Pain Education in Undergraduate Nursing Students
A study testing Jigsaw cooperative learning and Traditional Lecture-Based Education in people with Pediatric Pain Education, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Background Despite growing evidence supporting active learning methodologies in nursing education, limited evidence is available regarding the effectiveness of the Jigsaw cooperative learning technique in improving undergraduate nursing students' competencies in pediatric pain management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Pain Education
- What is being tested?
- Jigsaw cooperative learning and Traditional Lecture-Based Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Sep 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Third-year undergraduate nursing student.
- Attendance of the pediatric nursing course.
- Written informed consent.
Who cannot join
- Previous advanced education in pediatric pain management.
- Failure to complete baseline assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
UNIVERSITY OF PERUGIA - Degree Course in Nursing
Perugia
GIANDOMENICO GIUSTI, RN,MSN, +390755858021, GIANDOMENICO.GIUSTI@UNIPG.IT
About this study
Official title: Effectiveness of the Jigsaw Cooperative Learning Method on Undergraduate Nursing Students' Competencies in Pediatric Pain Management: A Multicenter Randomized Controlled Trial
Background
Despite growing evidence supporting active learning methodologies in nursing education, limited evidence is available regarding the effectiveness of the Jigsaw cooperative learning technique in improving undergraduate nursing students' competencies in pediatric pain management.
Read more
Objective
To evaluate whether the Jigsaw cooperative learning method improves nursing students' knowledge and attitudes regarding pediatric pain management compared with traditional lecture-based education.
Methods
This multicenter, parallel-group randomized controlled trial will be conducted among third-year undergraduate nursing students from the University of Perugia and Unilink University (Italy). Participants will be randomly allocated (1:1) to either a Jigsaw-based educational intervention or traditional lecture-based teaching. Knowledge and attitudes will be assessed using the Italian validated Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) at baseline (T0), immediately after the intervention (T1), and 30 days later (T2). Student satisfaction will also be evaluated using a Visual Analogue Scale (VAS).
Read the detailed description
This multicenter randomized controlled trial aims to evaluate the effectiveness of the Jigsaw cooperative learning technique in undergraduate nursing education.
Participants will be recruited from two Italian universities offering undergraduate nursing programs.
Following written informed consent, eligible participants will complete baseline assessment using the Italian validated Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS).
Participants will then be randomized (1:1), using computer-generated block randomization stratified by study site, to either:
Jigsaw cooperative learning Traditional lecture-based education
Both groups will receive identical educational content concerning pediatric pain management.
The intervention will last two weeks with approximately five hours of structured educational activities.
Outcome assessments will be performed immediately after the intervention (T1) and at 30-day follow-up (T2).
The primary endpoint will be the total PNKAS score immediately after the intervention.
Secondary outcomes include knowledge retention, longitudinal score changes, effect size estimation, and student satisfaction.
- Conditions
- Pediatric Pain Education
- Being tested
- Jigsaw cooperative learning, Traditional Lecture-Based Education
- Keywords
- Cooperative Learning, Jigsaw, Nursing Education, Pediatric Pain, Undergraduate Nursing Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jigsaw cooperative learningOther
Educational intervention based on the Jigsaw cooperative learning technique
Traditional Lecture-Based EducationOther
Conventional lecture-based teaching covering identical educational content
| Study group | Role | What they receive |
|---|---|---|
| Jigsaw Cooperative Learning | Experimental | Educational intervention based on the Jigsaw cooperative learning technique. Receives: Other: Jigsaw cooperative learning |
| Traditional Lecture-Based Education | Active comparator | Conventional lecture-based teaching covering identical educational content. Receives: Other: Traditional Lecture-Based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score.
Total score on the Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS). The PNKAS consists of 42 items with a total score ranging from 0 to 42, where higher scores indicate greater knowledge and more appropriate attitudes toward pediatric pain management.
Measured: Immediately after intervention (T1)
Secondary outcomes (5)
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from baseline (T0) to T1
Change in the total score on the Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) from baseline (T0) to immediately after the intervention (T1). The total score ranges from 0 to 42. Higher scores indicate better knowledge and attitudes regarding pediatric pain management.
Measured: Immediately after intervention
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score at 30-day follow-up
Total score on the Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) at 30-day follow-up (T2). The total score ranges from 0 to 42. Higher scores indicate better knowledge and attitudes regarding pediatric pain management.
Measured: 30 days
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T1 to T2
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T1 to T2
Measured: 30 days
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T0 to T2
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T0 to T2
Measured: 30 days
Student satisfaction assessed by Visual Analogue Scale (0-10)
Student satisfaction measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "extremely satisfied." Higher scores indicate greater satisfaction with the educational intervention.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Pain 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
- Participants will be randomly assigned in a 1:1 ratio to either Jigsaw cooperative learning or traditional lecture-based education. Randomization will be stratified by study site.
- Masking
- None (open label)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Faina, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735299
- Sponsor's protocol ID
- UNIPG-JIGSAW-PAIN-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Jigsaw Cooperative Learning Method on Undergraduate Nursing Students' Competencies in Pediatric Pain Management: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07735299
- Acronym / sponsor ID
- UNIPG-JIGSAW-PAIN-RCT-2026-01
- Conditions
- Pediatric Pain Education
- Keywords
- Cooperative Learning, Jigsaw, Nursing Education, Pediatric Pain, Undergraduate Nursing Students
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
Background
Despite growing evidence supporting active learning methodologies in nursing education, limited evidence is available regarding the effectiveness of the Jigsaw cooperative learning technique in improving undergraduate nursing students' competencies in pediatric pain management.
Objective
To evaluate whether the Jigsaw cooperative learning method improves nursing students' knowledge and attitudes regarding pediatric pain management compared with traditional lecture-based education.
Methods
This multicenter, parallel-group randomized controlled trial will be conducted among third-year undergraduate nursing students from the University of Perugia and Unilink University (Italy). Participants will be randomly allocated (1:1) to either a Jigsaw-based educational intervention or traditional lecture-based teaching. Knowledge and attitudes will be assessed using the Italian validated Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) at baseline (T0), immediately after the intervention (T1), and 30 days later (T2). Student satisfaction will also be evaluated using a Visual Analogue Scale (VAS).
Detailed description
This multicenter randomized controlled trial aims to evaluate the effectiveness of the Jigsaw cooperative learning technique in undergraduate nursing education.
Participants will be recruited from two Italian universities offering undergraduate nursing programs.
Following written informed consent, eligible participants will complete baseline assessment using the Italian validated Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS).
Participants will then be randomized (1:1), using computer-generated block randomization stratified by study site, to either:
Jigsaw cooperative learning Traditional lecture-based education
Both groups will receive identical educational content concerning pediatric pain management.
The intervention will last two weeks with approximately five hours of structured educational activities.
Outcome assessments will be performed immediately after the intervention (T1) and at 30-day follow-up (T2).
The primary endpoint will be the total PNKAS score immediately after the intervention.
Secondary outcomes include knowledge retention, longitudinal score changes, effect size estimation, and student satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either Jigsaw cooperative learning or traditional lecture-based education. Randomization will be stratified by study site.
| Arm | Type | Receives |
|---|---|---|
| Jigsaw Cooperative Learning | Experimental | Other: Jigsaw cooperative learningEducational intervention based on the Jigsaw cooperative learning technique. |
| Traditional Lecture-Based Education | Active comparator | Other: Traditional Lecture-Based EducationConventional lecture-based teaching covering identical educational content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Third-year undergraduate nursing student.
- Attendance of the pediatric nursing course.
- Written informed consent.
Key exclusion criteria (2 listed)
- Previous advanced education in pediatric pain management.
- Failure to complete baseline assessment.
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 |
|---|---|---|
| Jigsaw cooperative learningEducational intervention based on the Jigsaw cooperative learning technique | Other | Jigsaw Cooperative Learning |
| Traditional Lecture-Based EducationConventional lecture-based teaching covering identical educational content | Other | Traditional Lecture-Based Education |
Primary outcome
Total Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score.
Time frame: Immediately after intervention (T1)
Total score on the Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS). The PNKAS consists of 42 items with a total score ranging from 0 to 42, where higher scores indicate greater knowledge and more appropriate attitudes toward pediatric pain management.
5 secondary outcomes
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from baseline (T0) to T1
Time frame: Immediately after intervention
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score at 30-day follow-up
Time frame: 30 days
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T1 to T2
Time frame: 30 days
Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score change from T0 to T2
Time frame: 30 days
Student satisfaction assessed by Visual Analogue Scale (0-10)
Time frame: Immediately after intervention
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 29 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jigsaw cooperative learning and Traditional Lecture-Based Education in people with Pediatric Pain Education, run by University of Rome Tor Vergata at 1 site in Italy.
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 3 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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 Italy. 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?
Contact FABRIZIO FAINA, RN, MSN (+393472651617, fabrizio.faina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pediatric Nurses' Knowledge and Attitudes Survey Regarding Pain (PNKAS) score. (time frame: Immediately after intervention (T1)). 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 29 Jul 2026.