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| Name | Class |
|---|---|
| Jinhua Municipal Central Hospital | OTHER |
| Lishui Country People's Hospital | OTHER |
| Ningbo No.2 Hospital | OTHER |
| The Central Hospital of Lishui City |
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Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-Centered group (F group) | Experimental | Both children and parents received family-centred perioperative care for anaesthesia including video education, anaesthesia mask practice, e-manual learning,etc. It is also recommended that a parent accompany the child during both anesthesia induction and recovery. |
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| Routine group (R group) | No Intervention | The child received clinical standard preoperative education and anesthesia induction. The child was not accompanied by the parents during the anesthesia induction period and the awakening period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-centred perioperative care for anaesthesia | Other | The patient in intervention group and parent will receive the Family-centred perioperative care for anaesthesia, including video education, anaesthesia mask practice, electronic pamphlet,etc. It is recommended that parents accompany the children during the induction of anesthesia and the recovery from anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergency delirium | The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED). When the child wakes up in the PACU (the child can stay awake for more than 10 seconds), and 5min, 15min, 25min after waking up, a trained researcher will evaluate the PAED score (the maximum scores ≥10 will be diagnosed as ED). | At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake; |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of emergency delirium | The severity of emergency delirium was assessed according to PAED scores in those patients who suffered emergency delirium. A total score ≥12 is considered moderate emergency delirium, ≥15 is considered severe emergency delirium, and the total score of the scale is 20. | At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake; |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Li, MD. PhD | Contact | +86-135-8787-6896 | liting1021@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Ting Li, MD. PhD | Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40623754 | Derived | Chen J, Hu J, Zheng C, Song S, Yang C, Ye F, Li T. Effect of family-centred perioperative care for anaesthesia on the incidence of emergence delirium in children after surgery: a protocol for a randomised controlled trial in China. BMJ Open. 2025 Jul 6;15(7):e089863. doi: 10.1136/bmjopen-2024-089863. |
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Study protocol and statistical analysis plan.
Beginning 6 months after publication with no end date
De-identified participant data underlying the findings will be made available upon reasonable request. Proposals for data access should be directed to the corresponding author (liting1021@aliyun.com).
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| OTHER |
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| The incidence of postoperative maladaptive behaviours | Postoperative maladaptive behavioural changes at the 1, 2, 3, 7±2, 14±3 days and 3 months±5 days after surgery will be assessed with Post Hospitalization Behaviour Questionnaire (PHBQ). When total score greater than 0 will be considered as postoperative maladaptive behaviours. | at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery |
| Sleep quality | Sleep quality before surgery and at 7±2, 14±3 days and 3 months ±5 days after surgery, assessed with Children's Sleep Habits Questionnaire (CSHQ). | Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery |
| Quality of life score | Quality of life score will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0). | Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery. |
| Compliance of anaesthesia induction | Compliance of anaesthesia induction in children will be assessed with Induction Compliance Checklist (ICC). | The period anaesthesia induction. |
| Postoperative pain score | Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC). | At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake. |
| Preoperative anxiety of children | Preoperative anxiety of children will be assessed with the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). | Baseline before surgery, in the preoperative holding area and during induction of anaesthesia. |
| Preoperative anxiety of parents | Preoperative anxiety of parents will be assessed with State Trait Anxiety Inventory (STAI). | Baseline before surgery, in the preoperative holding area and during induction of anaesthesia. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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