Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04973150
Other study ID # dpf199438
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2022

Study information

Verified date May 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. After eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. In clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. How to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 350
Est. completion date June 1, 2022
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria: 1. Ages 3-7; 2. Selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation); 3. No mental disorders, stunting and low intelligence; 4. There is no other history of surgical hospitalization. Exclusion Criteria: 1. Those who have completed the operation under local anesthesia; 2. People with visual impairment of both eyes; 3. Eyeball removal and/or eye socket implanter; 4. Hearing and language impairment cannot communicate normally; 5. Have a history of taking psychotropic drugs; 6. People with severe organs such as the heart, lungs, brains and kidneys.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children.
To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children. Methods A total of 300 preschool-age children who underwent general anesthesia of selective ophthalmic surgery in a 3A grade hospital from August 2019 to July 2020 were selected as the research object, who were divided into experimental group and control group with 150 cases each by random number table. Children in the control group received regular education on cartoon animation videos before surgery; children in the experimental group received eye-covering pretreatment on the basis of cartoon animation videos. The differences in preoperative anxiety degree score, postoperative acute delirium incidence, delirium degree score, and postoperative nursing care difficulty score were compared between the two groups.

Locations

Country Name City State
China peifang Dong Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety The modified Yale preoperative anxiety scale (m-ypas) was used to evaluate the preoperative anxiety. The scale has high reliability and validity (Cronbach's) a The reliability coefficient was 0.936; 91). The scale is often used to evaluate the preoperative anxiety level of children aged 2-12 in the waiting room, going to the operating room, entering the operating room and anesthesia induction period. The questionnaire consists of 5 parts and 22 items, which are language (4 items), vocalization (6 items), emotional expression (4 items), obvious alertness (4 items), and the role of parents (4 items). In addition to the vocal part of 1-6 points, the rest are 1-4 points, the minimum is 0 points, the maximum is 100 points, the higher the score, the higher the anxiety level of the subjects. The scale was evaluated by the anesthesiologist when the child entered the operating room, and the evaluation time was about 2 minutes. Up to 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03310216 - The Clinical Application of Artificial Intelligent(AI) Visual Inspection System N/A
Completed NCT05294640 - Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures Phase 4
Recruiting NCT04890496 - Analysis of Hospitalization Data From ZOC
Completed NCT04327752 - Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease
Completed NCT03938883 - Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK") N/A
Recruiting NCT04980430 - Community Interest in Vision Screening Technology
Recruiting NCT04892316 - Using Machine Learning to Adapt Visual Aids for Patients With Low Vision
Recruiting NCT04919837 - The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial N/A
Not yet recruiting NCT02825186 - Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery N/A
Recruiting NCT05588921 - LensAge to Reveal Biological Age
Active, not recruiting NCT05682105 - Detection of Jaundice From Ocular Images Via Deep Learning
Completed NCT04213183 - Screening and Identifying Hepatobiliary Diseases Via Deep Learning Using Ocular Images
Recruiting NCT05223712 - Artificial Intelligence System for the Detection and Prediction of Kidney Diseases Using Ocular Information
Completed NCT01771081 - Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy N/A