NCT07325890

Brief Summary

The purpose of this study is to understand whether the decision tree for Child Life is effective in improving the professional level and working effect of Child Life Specialists. The main questions it aims to answer are:

  1. 1.Does the decision tree for Child Life enhance the professional knowledge level of Child Life Specialists?
  2. 2.Has the decision tree for Child Life improved the work effectiveness of Child Life Specialists?
  3. 3.Has the application of Child Life decision trees improved children's pain levels and compliance?
  4. 4.Receive training on the application of decision trees for Child Life.
  5. 5.Apply the decision tree for Child Life to carry out intervention in Child Life intervention.
  6. 6.Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.
  7. 7.Conduct Child Life intervention based on one's own experience and professional level.
  8. 8.Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

December 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 25, 2025

Last Update Submit

March 20, 2026

Conditions

Keywords

Child Life

Outcome Measures

Primary Outcomes (1)

  • Clinical anxiety and cooperative behavior manifestations of the child patient

    Before and after each intervention, researchers collected on-site the clinical anxiety and cooperative behavior manifestations of the children included in the intervention plan. The scoring range of this scale is from 0 to 5, with a total of six points. A score of 0 indicates ease, 1 indicates discomfort, 2 indicates tension, 3 indicates reluctance, 4 indicates fear, and 5 indicates loss of control. The higher the score, the more resistant the child is to treatment and the poorer the degree of cooperation. It is generally believed that children with a score of 4 or 5 are unable to cooperate with the treatment.

    From enrollment to the end of intervention at 2 months

Secondary Outcomes (4)

  • Questionnaire on Knowledge of Child Life Specialists

    From enrollment to the end of training at 2 months

  • Questionnaire on the Evaluation of the Work Effect of Child Life Specialists

    Each intervention ended after enrollment

  • Competency Level of Child Life Specialists

    From enrollment to the end of training at 2 months

  • FACES Pain Scale

    From enrollment to the end of intervention at 2 months

Study Arms (2)

Applying decision tree of Child Life for children

EXPERIMENTAL

(1) The decision tree for Child Life was applied to conduct Child Life intervention for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists.

Other: decision tree for Child Life

Routine Child Life intervention for children

ACTIVE COMPARATOR

(1) Routine Child Life intervention was applied for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists.

Other: Routine Child Life intervention for children

Interventions

Four training sessions on decision tree for Child Life were conducted for Child Life Specialists. The training content was produced by the research team based on previous literature and clinical experience. After the training, Child Life Specialists will apply the Child Life decision tree in clinical practice to carry out Child Life intervention.

Applying decision tree of Child Life for children

Child Life Specialists will conduct Child Life intervention for children based on their professional knowledge and clinical experience in clinical practice.

Routine Child Life intervention for children

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have received training in relevant courses on Child Life.
  • Have been engaged in clinical practice of Child Life for at least one year.

You may not qualify if:

  • Those who are currently on internship, in further education, or not directly involved in clinical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Interventions

Decision Trees

Intervention Hierarchy (Ancestors)

Decision TheoryMathematical Concepts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

December 1, 2025

Primary Completion

January 31, 2026

Study Completion

March 20, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations