NCT06431802

Brief 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. 1.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?
  2. 2.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?
  3. 3.Use the visualization platform or receive on-site lessons for pain assessment training every week for 1 month.
  4. 4.Test before and 1 month after the start of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

May 17, 2024

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline, 1st month since baseline

Study Arms (2)

Conventional intervention group

ACTIVE COMPARATOR

On-site course training in pain assessment

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

Behavioral: Platform intervention

Interventions

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.

Conventional intervention group

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.

Platform intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obtain a Nurse Practitioner's Certificate;
  • Nurses working in critical care;
  • Voluntarily participate in this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ying Gu, Doctor

    Children's Hospital of Fudan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 29, 2024

Study Start

July 2, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations