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

NCT04973150 | Unknown

• 1 other identifier: dpf199438
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Ophthalmology

Keywords

Pre-school Aged Children; Acute Delirium; Eye-covering Pretreatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 weeks

Study Arms (2)

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

EXPERIMENTAL

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

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.

Using regular tablet computer to play cartoon animation video

NO INTERVENTION

Interventions

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. 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. 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.

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

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

peifang Dong

Hangzhou, China

Location

Related Publications (1)

• 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.

  PMID: 36157681 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head nurse

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 22, 2021
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CN (1)