OphthalmologyNCT04973150
Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
A study testing 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. in people with Ophthalmology, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmology
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 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.
- Keywords
- Pre-school Aged Children, Acute Delirium, Eye-covering Pretreatment
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jun 2020
- Primary completion1 May 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG Peifang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973150
- Sponsor's protocol ID
- dpf199438
- Status last verified
- May 2022
- First submitted
- 20 Jun 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36157681
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
- ClinicalTrials.gov ID
- NCT04973150
- Acronym / sponsor ID
- dpf199438
- Conditions
- Ophthalmology
- Keywords
- Pre-school Aged Children, Acute Delirium, Eye-covering Pretreatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the children were given gauze covering training in one eye or both eyes | Experimental | 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.According to the operation method, the children were given gauze covering training in one eye or both eyes. |
| Using regular tablet computer to play cartoon animation video | No intervention | – |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | the children were given gauze covering training in one eye or both eyes |
Primary outcome
Anxiety
Time frame: Up to 24 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 36157681Dong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Ophthalmology, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.