Postoperative ComplicationsNCT06092671
Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
A study testing Family-centred perioperative care for anaesthesia in people with Postoperative Complications and Child, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Postoperative Complications, Child, Family
- What is being tested?
- Family-centred perioperative care for anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
- Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
- A parent signed the informed consent form.
Who cannot join
- Suffering important organ diseases;
- History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
- History of severe hearing or visual impairment;
- Children are not suitable for inhalation anaesthesia considered by the researchers;
- The parent involving in this trial spends less than three months a year with the child;
- The parent is not competent for companionship considered by the researchers;
- Neither father nor mother is able to participate in the screening interview and the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Ting Li, MD. PhD, +86-135-8787-6896, liting1021@aliyun.com
About this study
Official title: Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
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.
- Conditions
- Postoperative Complications, Child, Family, Emergence Delirium, General Anaesthesia, Perioperative Care
- Being tested
- Family-centred perioperative care for anaesthesia
- Keywords
- perioperative care, emergency delirium, paediatric, general anaesthesia, postoperative maladaptive behaviours
- Medical subject headings
- Postoperative Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centred perioperative care for anaesthesiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Family-centred perioperative care for anaesthesia |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
Secondary outcomes (8)
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.
Measured: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: The period anaesthesia induction.
Postoperative pain score
Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC).
Measured: 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).
Measured: 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).
Measured: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start24 Oct 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (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 Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital, Lishui Country People's Hospital, Ningbo No.2 Hospital, The Central Hospital of Lishui City
- Responsible party
- Principal investigator, TING LI, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Ting Li, MD. PhD, Principal investigator, Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092671
- Sponsor's protocol ID
- SAHoWMU-CR2023-03-110
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan.
Publications
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.
PubMed 40623754
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06092671
- Acronym / sponsor ID
- SAHoWMU-CR2023-03-110
- Conditions
- Postoperative Complications, Child, Family, Emergence Delirium, General Anaesthesia, Perioperative Care
- Keywords
- perioperative care, emergency delirium, paediatric, general anaesthesia, postoperative maladaptive behaviours
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital, Lishui Country People's Hospital, Ningbo No.2 Hospital, The Central Hospital of Lishui City
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-Centered group (F group) | Experimental | Other: Family-centred perioperative care for anaesthesiaBoth 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. |
| 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
- Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
- A parent signed the informed consent form.
Key exclusion criteria (7 listed)
- Suffering important organ diseases;
- History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
- History of severe hearing or visual impairment;
- Children are not suitable for inhalation anaesthesia considered by the researchers;
- The parent involving in this trial spends less than three months a year with the child;
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 |
|---|---|---|
| Family-centred perioperative care for anaesthesiaThe 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. | Other | Family-Centered group (F group) |
Primary outcome
The incidence of emergency delirium
Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
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).
8 secondary outcomes
The severity of emergency delirium
Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
The incidence of postoperative maladaptive behaviours
Time frame: at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery
Sleep quality
Time frame: Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery
Quality of life score
Time frame: Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.
Compliance of anaesthesia induction
Time frame: The period anaesthesia induction.
Postoperative pain score
Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.
Preoperative anxiety of children
Time frame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Preoperative anxiety of parents
Time frame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 40623754Chen 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.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan.
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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.
Ting Li, MD. PhD principal investigator
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centred perioperative care for anaesthesia in people with Postoperative Complications and Child, run by Second Affiliated Hospital of Wenzhou Medical University 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Li, MD. PhD (+86-135-8787-6896, liting1021@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of emergency delirium (time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;). 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 NCT06092671, 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 29 Dec 2025.