PediatricsNCT06431802
Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children
A study testing Conventional intervention and Platform intervention in people with Pediatrics and Critical Illness, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children is applicable for pain assessment training. The study aims to answer: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatrics, Critical Illness, Pain Measurement
- What is being tested?
- Conventional intervention and Platform intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 30 Sep 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Obtain a Nurse Practitioner's Certificate;
- Nurses working in critical care;
- Voluntarily participate in this study.
Who cannot join
- Nurses in the neonatal unit (due to the specificity of pain assessment in neonates);
- Not on duty during the survey period due to further training, rotations, sick leave, maternity leave, etc.;
- Nurses who travel to our hospital for further training, rotations, or clinical placements during the survey period;
- Those who fail to complete the full intervention or withdrew from the study midway.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children is applicable for pain assessment training. The study aims to answer:
- Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' knowledge level of pain assessment?
- Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' skill level of pain assessment?
Read more
Researchers will compare a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children to on-site lessons to see how well the platform intervention can be applied to pain assessment training.
Participants will:
- Use the visualization platform or receive on-site lessons for pain assessment training every week for 1 month.
- Test before and 1 month after the start of the study.
Read the detailed description
In pediatric intensive care units, children are often faced with complex and critical conditions that require frequent procedures which may cause pain, and experience varying degrees of pain. Pain can have serious negative effects on the physiological, psychological, and social well-being of critically ill children, and may even lead to long-term distress, impeding both individual growth and overall health. Reliable pain assessment can help healthcare professionals to better understand the type and extent of pain in children, so that appropriate interventions can be taken to better manage the child's pain and thereby improve the child's health outcomes. However, pediatric nurses face challenges from the child, observational indicators, and the individual themselves during pain assessment in the clinic. Training in pain assessment can effectively improve nurses' knowledge, skills and attitudes, enabling them to better cope with the difficulties associated with pain assessment, thereby improving the quality of pain management and providing optimal pain care for children. Traditional training has many drawbacks, and there are various difficulties in pain assessment training for critically ill children, which brings various challenges to pain assessment training for pediatric ICU nurses. Visualization training, being intuitive, interactive, and personalized, offers unique advantages over traditional training methods. The union of deliberate practice with visualization training can further enhance the training effect, and help pediatric ICU nurses' pain assessment ability to be comprehensively improved through purposeful practice, timely feedback, and repeated training and challenges, so that they can more accurately identify and assess children's pain. Therefore, a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children will be constructed for pain assessment training to promote better improvement of pain assessment ability of pediatric ICU nurses, so that pain in critically ill children can be better managed.
- Conditions
- Pediatrics, Critical Illness, Pain Measurement
- Being tested
- Conventional intervention, Platform intervention
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional interventionOther
A nursing specialist with extensive clinical and teaching experience will provide on-site course training. The training will cover topics related to pain and pain assessment, such as: pain definition, types, physiological mechanisms, performance, pain assessment tools, and frequency of pain assessment. Interventions will be provided once a week for 4 weeks.
Platform interventionBehavioural
Using a pre-assigned account to log in to the platform, read the guidance instructions and enter the platform to start training. Basic knowledge of pain and pain assessment can be learnt through the Learning Resources module on the platform, and pain assessment training can be conducted through the Pain Assessment Exercise module. During pain assessment training the platform provides instant feedback based on the participant's exercises. Interventions will be completed in 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional intervention group | Active comparator | On-site course training in pain assessment Receives: Other: Conventional intervention |
| Platform intervention group | Experimental | Pain assessment training using the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children Receives: Behavioral: Platform intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge level of pain assessment
Use the Pediatric ICU Nurses' Pain Assessment Knowledge Test，which is measured on a scale from 0 to 100 points. The higher the total score, the higher the level of knowledge.
Measured: baseline, 1st month since baseline
Skill level of pain assessment
The pediatric pain assessment cases developed by the research team will be utilized for evaluation. The correct percentage range is from 0% to 100%, with higher percentages indicating a higher skill level in pain assessment.
Measured: baseline, 1st month since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start2 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 PediatricsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Gu, Doctor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431802
- Sponsor's protocol ID
- FNF20231219
- Status last verified
- Apr 2025
- First submitted
- 17 May 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rong X, Fu W, Jin Y, Yang Y, Shen W, Xu Y, Qin Y, Zhang X, Gu Y. Impact of a Visualization Training Platform on PICU Nurses' Pain Assessment Skill in Critically Ill Children: A Mixed-Methods Randomized Controlled Trial. Nurs Open. 2026 Aug;13(8):e70741. doi: 10.1002/nop2.70741.
PubMed 42641083
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children
- ClinicalTrials.gov ID
- NCT06431802
- Acronym / sponsor ID
- FNF20231219
- Conditions
- Pediatrics, Critical Illness, Pain Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 May 2024 (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 goal of this clinical trial is to learn if the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children is applicable for pain assessment training. The study aims to answer:
- Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' knowledge level of pain assessment?
- Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' skill level of pain assessment?
Researchers will compare a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children to on-site lessons to see how well the platform intervention can be applied to pain assessment training.
Participants will:
- Use the visualization platform or receive on-site lessons for pain assessment training every week for 1 month.
- Test before and 1 month after the start of the study.
Detailed description
In pediatric intensive care units, children are often faced with complex and critical conditions that require frequent procedures which may cause pain, and experience varying degrees of pain. Pain can have serious negative effects on the physiological, psychological, and social well-being of critically ill children, and may even lead to long-term distress, impeding both individual growth and overall health. Reliable pain assessment can help healthcare professionals to better understand the type and extent of pain in children, so that appropriate interventions can be taken to better manage the child's pain and thereby improve the child's health outcomes. However, pediatric nurses face challenges from the child, observational indicators, and the individual themselves during pain assessment in the clinic. Training in pain assessment can effectively improve nurses' knowledge, skills and attitudes, enabling them to better cope with the difficulties associated with pain assessment, thereby improving the quality of pain management and providing optimal pain care for children. Traditional training has many drawbacks, and there are various difficulties in pain assessment training for critically ill children, which brings various challenges to pain assessment training for pediatric ICU nurses. Visualization training, being intuitive, interactive, and personalized, offers unique advantages over traditional training methods. The union of deliberate practice with visualization training can further enhance the training effect, and help pediatric ICU nurses' pain assessment ability to be comprehensively improved through purposeful practice, timely feedback, and repeated training and challenges, so that they can more accurately identify and assess children's pain. Therefore, a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children will be constructed for pain assessment training to promote better improvement of pain assessment ability of pediatric ICU nurses, so that pain in critically ill children can be better managed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional intervention group | Active comparator | Other: Conventional interventionOn-site course training in pain assessment |
| Platform intervention group | Experimental | Behavioral: Platform interventionPain assessment training using the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Obtain a Nurse Practitioner's Certificate;
- Nurses working in critical care;
- Voluntarily participate in this study.
Key exclusion criteria (4 listed)
- Nurses in the neonatal unit (due to the specificity of pain assessment in neonates);
- Not on duty during the survey period due to further training, rotations, sick leave, maternity leave, etc.;
- Nurses who travel to our hospital for further training, rotations, or clinical placements during the survey period;
- Those who fail to complete the full intervention or withdrew from the study midway.
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 |
|---|---|---|
| Conventional interventionA nursing specialist with extensive clinical and teaching experience will provide on-site course training. The training will cover topics related to pain and pain assessment, such as: pain definition, types, physiological mechanisms, performance, pain assessment tools, and frequency of pain assessment. Interventions will be provided once a week for 4 weeks. | Other | Conventional intervention group |
| Platform interventionUsing a pre-assigned account to log in to the platform, read the guidance instructions and enter the platform to start training. Basic knowledge of pain and pain assessment can be learnt through the Learning Resources module on the platform, and pain assessment training can be conducted through the Pain Assessment Exercise module. During pain assessment training the platform provides instant feedback based on the participant's exercises. Interventions will be completed in 4 weeks. | Behavioural | Platform intervention group |
Primary outcome
Knowledge level of pain assessment
Time frame: baseline, 1st month since baseline
Use the Pediatric ICU Nurses' Pain Assessment Knowledge Test，which is measured on a scale from 0 to 100 points. The higher the total score, the higher the level of knowledge.
Skill level of pain assessment
Time frame: baseline, 1st month since baseline
The pediatric pain assessment cases developed by the research team will be utilized for evaluation. The correct percentage range is from 0% to 100%, with higher percentages indicating a higher skill level in pain assessment.
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 9 Apr 2025.
- Derived from this study: PubMed 42641083Rong X, Fu W, Jin Y, Yang Y, Shen W, Xu Y, Qin Y, Zhang X, Gu Y. Impact of a Visualization Training Platform on PICU Nurses' Pain Assessment Skill in Critically Ill Children: A Mixed-Methods Randomized Controlled Trial. Nurs Open. 2026 Aug;13(8):e70741. doi: 10.1002/nop2.70741.
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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.
Ying Gu, Doctor study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional intervention and Platform intervention in people with Pediatrics and Critical Illness, run by Children's Hospital of Fudan University at 1 site in China.
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 4 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 9 Apr 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 China. 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?
Knowledge level of pain assessment (time frame: baseline, 1st month since 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?
On the ClinicalTrials.gov record for NCT06431802, 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 9 Apr 2025.