## Protocol Section
### Identification Module
**NCT ID:** NCT06431802

**Brief Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children

**Official Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children

#### Organization Study ID Info
**ID:** FNF20231219
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Fudan University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 main questions it aims to answer are:

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. 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 lesson to see how well the platform intervention can be applied to pain assessment training.

Participants will:

1. Use the visualisation platform or receive on-site lesson for pain assessment training every week for 1 month
2. 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 pain-causing operations and experience varying degrees of pain. Pain has serious negative physiological, psychological, and social effects on critically ill children, and may even cause long-term distress, hindering individual growth and long-term 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 towards pain assessment, 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 is intuitive, interactive and personalized, showing unique advantages different from traditional training. 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 Module

**Conditions:**

- Pediatrics

- Critical Illness

- Pain Measurement

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** On-site course training in pain assessment

**Intervention Names:**

- Other: Conventional intervention

**Label:** Conventional intervention group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Pain assessment training using the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children

**Intervention Names:**

- Behavioral: Platform intervention

**Label:** Platform intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional intervention group

**Description:** 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.

**Name:** Conventional intervention

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Platform intervention group

**Description:** 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.

**Name:** Platform intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Knowledge level of pain assessment

**Time Frame:** before and 1 month after the start of the study

**Description:** 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.

**Measure:** Skill level of pain assessment

**Time Frame:** before and 1 month after the start of the study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

1. Nurses in the neonatal unit (due to the specificity of pain assessment in neonates);
2. Not on duty during the survey period due to further training, rotations, sick leave, maternity leave, etc.;
3. Nurses who travel to our hospital for further training, rotations, or clinical placements during the survey period;
4. Those who fail to complete the full intervention or withdrew from the study midway.

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** guying0128@aliyun.com

**Name:** Ying Gu, Doctor

**Phone:** +86 13816881726

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Children's Hospital of Fudan University

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital of Fudan University

**Name:** Ying Gu, Doctor

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016638

- Term: Critical Illness

### Misc Info Module

- Version Holder: 2024-05-31
