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

NCT ID: NCT04973150

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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 Type: 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.

Using regular tablet computer to play cartoon animation video

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

DONG Peifang

Head nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

peifang Dong

Hangzhou, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36157681 (View on PubMed)

Other Identifiers

dpf199438

Identifier Type: -

Identifier Source: org_study_id