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Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children

Primary Purpose

Ophthalmology

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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.
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ophthalmology focused on measuring Pre-school Aged Children, Acute Delirium, Eye-covering Pretreatment

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • peifang Dong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the children were given gauze covering training in one eye or both eyes

Using regular tablet computer to play cartoon animation video

Arm Description

According to the operation method, the children were given gauze covering training in one eye or both eyes.

Outcomes

Primary Outcome Measures

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) α 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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2021
Last Updated
May 22, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04973150
Brief Title
Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
Official Title
Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ophthalmology
Keywords
Pre-school Aged Children, Acute Delirium, Eye-covering Pretreatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the children were given gauze covering training in one eye or both eyes
Arm Type
Experimental
Arm Description
According to the operation method, the children were given gauze covering training in one eye or both eyes.
Arm Title
Using regular tablet computer to play cartoon animation video
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
The modified Yale preoperative anxiety scale (m-ypas) was used to evaluate the preoperative anxiety. The scale has high reliability and validity (Cronbach's) α 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.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 3-7; Selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation); No mental disorders, stunting and low intelligence; There is no other history of surgical hospitalization. Exclusion Criteria: Those who have completed the operation under local anesthesia; People with visual impairment of both eyes; Eyeball removal and/or eye socket implanter; Hearing and language impairment cannot communicate normally; Have a history of taking psychotropic drugs; People with severe organs such as the heart, lungs, brains and kidneys.
Facility Information:
Facility Name
peifang Dong
City
Hangzhou
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36157681
Citation
Dong PF, Qiao DN, Chen HL, Lu SH, Qu SH, Wu YT, Zhao D, Wan T. Effect of Different Durations of Eye-Covering Pretreatment on Emergence Delirium after Ophthalmic Surgery in Preschool-Aged Children: A Randomized Controlled Study. J Ophthalmol. 2022 Sep 16;2022:3656148. doi: 10.1155/2022/3656148. eCollection 2022.
Results Reference
derived

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Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children

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