Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
May 22, 2022 updated by: DONG Peifang, Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Anticipated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hangzhou, China
- peifang Dong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 7 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: the children were given gauze covering training in one eye or both eyes
According to the operation method, the children were given gauze covering training in one eye or both eyes.
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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.
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NO_INTERVENTION: Using regular tablet computer to play cartoon animation video
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: Up to 24 weeks
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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.
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Up to 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2020
Primary Completion (ACTUAL)
May 1, 2021
Study Completion (ANTICIPATED)
June 1, 2022
Study Registration Dates
First Submitted
June 20, 2021
First Submitted That Met QC Criteria
July 13, 2021
First Posted (ACTUAL)
July 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 22, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dpf199438
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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