Emergence AgitationNCT07486427
Effects of Preoperative Child and Parental Anxiety on Emergence Agitation
An observational study of Emergence Agitation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Emergence Agitation
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Feb 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Child
Study population: Pediatric patients aged 3-7 years who underwent adenotonsil surgery in the ear, nose, throat (ENT) operating room of Ondokuz Mayıs University Hospital and their parents
Who may be able to join
- Patients aged 3-7 years who will undergo adenoidectomy, adenotonsillectomy or tonsillectomy surgery and their parents
- Patients with ASA (American Society of Anesthesiologists) physical status I/II
Who cannot join
- Patients with ASA score III and above
- Conditions that prevent communication with the patient or parent (mental retardation, disability etc.)
- Patients in whom routinely scheduled anesthetic and analgesic drugs cannot be administered due to allergy or contraindication
- Patients who have previously received anesthesia or entered the operating room for a surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Child and Parental Anxiety on Emergence Agitation and Postoperative Pain in Children Undergoing Adenoidectomy and Tonsillectomy: a Prospective Observational Study
Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery
Read the detailed description
Adenotonsillectomy, with or without adenoidectomy, is one of the most commonly performed surgical procedures worldwide in pediatric patients. Despite its widespread application, this surgery presents significant challenges for both surgeons and anesthesiologists due to the associated increased risks of morbidity and mortality. Safe administration of anesthesia is critical in avoiding complications and alleviating not only patient distress but also parental anxiety.
Preoperative anxiety in pediatric patients is influenced by several factors, including young age and parental concerns. Additionally, longer surgery durations (>30 minutes) and previous hospitalizations are known risk factors for heightened anxiety. Several previous studies have explored the relationship between parental stress levels and postoperative complications, including emergence agitation and pain. Research indicates a significant association between parental anxiety and postoperative behavioral disturbances in children.
The primary objective of this study is to evaluate the impact of preoperative parental anxiety and sociodemographic characteristics on the incidence and severity of emergence agitation in pediatric patients undergoing adenotonsillectomy.
- Conditions
- Emergence Agitation
- Being tested
- No intervention - observational study
- Keywords
- emergence agitation, parental anxiety, sociodemographic characteristics
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational studyOther
no group
| Study group | Role | What they receive |
|---|---|---|
| observational | No intervention - cross sectional analysis Receives: Other: No intervention - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of emergence agitation
The incidence and severity of emergence agitation (EA) were evaluated in the postoperative recovery room using the Watcha Behavior Scale (WBS). The Watcha Behavior Scale is a four-point scale used to assess the severity of emergence agitation in pediatric patients after anesthesia: (1) calm and cooperative; (2) mild restlessness but easily consoled; (3) agitated and inconsolable; and (4) severely agitated, thrashing, or combative.
Measured: From 1 to 30 minutes after extubation
Secondary outcomes (3)
Parental preoperative anxiety
Parental preoperative anxiety was assessed after study enrollment. For patients admitted one day before surgery, evaluation was conducted on the evening before; for those admitted on the day of surgery, it was performed in the preoperative waiting area. Anxiety levels were measured using the State-Trait Anxiety Inventory (STAI), which consists of two subscales: the State Anxiety Inventory (STAI-S) and the Trait Anxiety Inventory (STAI-T), each including 20 items. Each item is rated on a 4-point Likert scale, with total scores ranging from 20 to 80 for each subscale. Higher scores indicate higher levels of anxiety.
Measured: during the preoperative day and the day of surgery
Preoperative anxiety in children
Children were accompanied by a parent until transfer to the operating room (OR). Preoperative anxiety levels were assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) before separation from parents and prior to any intervention or drug administration. The m-YPAS is an observational scale with scores ranging from 23.33 to 100, with higher scores indicating greater anxiety.
Measured: During the day of surgery
Postoperative pain
Postoperative pain was assessed in the post-anesthesia care unit (PACU) using the Wong-Baker Faces Pain Rating Scale. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain. Higher scores indicate greater pain intensity. Pain scores were recorded at predefined time points during the early postoperative period.
Measured: During the first 30 minutes in the post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Mar 2024
- Primary completion31 Oct 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Karakaya, Ondokuz Mayıs University
- Investigators
- Dilek Gemici, Specialist physician, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486427
- Sponsor's protocol ID
- EA140324
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
PubMed 15562048Ali AB, Khan F. Emergence Delirium and Its Association with Preoperative Anxiety in Paediatric Patients Undergoing Infra Umbilical Surgery Under Combined General and Caudal Anaesthesia: An Observational Study from a Tertiary Care Centre in a South Asian Country. Turk J Anaesthesiol Reanim. 2022 Apr;50(2):129-134. doi: 10.5152/TJAR.2021.1104.
PubMed 35544252Alves CS, Dias J, Azevedo S, Sousa F, Santos M, Lino J, Meireles L. Keep Calm: Does parental preoperative anxiety affect post-tonsillectomy pain scores in children? Eur Arch Otorhinolaryngol. 2024 Aug;281(8):4385-4392. doi: 10.1007/s00405-024-08683-0. Epub 2024 May 13.
PubMed 38739185Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820Yu H, Sun X, Li P, Deng X. Prevalence and risk factors of emergence agitation among pediatric patients undergo ophthalmic and ENT Surgery: a cross-sectional study. BMC Pediatr. 2023 Nov 24;23(1):598. doi: 10.1186/s12887-023-04434-y.
PubMed 37996779
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Child and Parental Anxiety on Emergence Agitation and Postoperative Pain in Children Undergoing Adenoidectomy and Tonsillectomy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07486427
- Acronym / sponsor ID
- EA140324
- Conditions
- Emergence Agitation
- Keywords
- emergence agitation, parental anxiety, sociodemographic characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 20 Mar 2026 (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.
Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery
Detailed description
Adenotonsillectomy, with or without adenoidectomy, is one of the most commonly performed surgical procedures worldwide in pediatric patients. Despite its widespread application, this surgery presents significant challenges for both surgeons and anesthesiologists due to the associated increased risks of morbidity and mortality. Safe administration of anesthesia is critical in avoiding complications and alleviating not only patient distress but also parental anxiety.
Preoperative anxiety in pediatric patients is influenced by several factors, including young age and parental concerns. Additionally, longer surgery durations (>30 minutes) and previous hospitalizations are known risk factors for heightened anxiety. Several previous studies have explored the relationship between parental stress levels and postoperative complications, including emergence agitation and pain. Research indicates a significant association between parental anxiety and postoperative behavioral disturbances in children.
The primary objective of this study is to evaluate the impact of preoperative parental anxiety and sociodemographic characteristics on the incidence and severity of emergence agitation in pediatric patients undergoing adenotonsillectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | Other: No intervention - observational studyNo intervention - cross sectional analysis |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 3-7 years who underwent adenotonsil surgery in the ear, nose, throat (ENT) operating room of Ondokuz Mayıs University Hospital and their parents
Key inclusion criteria (2 listed)
- Patients aged 3-7 years who will undergo adenoidectomy, adenotonsillectomy or tonsillectomy surgery and their parents
- Patients with ASA (American Society of Anesthesiologists) physical status I/II
Key exclusion criteria (4 listed)
- Patients with ASA score III and above
- Conditions that prevent communication with the patient or parent (mental retardation, disability etc.)
- Patients in whom routinely scheduled anesthetic and analgesic drugs cannot be administered due to allergy or contraindication
- Patients who have previously received anesthesia or entered the operating room for a surgical procedure
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 |
|---|---|---|
| No intervention - observational studyno group | Other | observational |
Primary outcome
Incidence and severity of emergence agitation
Time frame: From 1 to 30 minutes after extubation
The incidence and severity of emergence agitation (EA) were evaluated in the postoperative recovery room using the Watcha Behavior Scale (WBS). The Watcha Behavior Scale is a four-point scale used to assess the severity of emergence agitation in pediatric patients after anesthesia: (1) calm and cooperative; (2) mild restlessness but easily consoled; (3) agitated and inconsolable; and (4) severely agitated, thrashing, or combative.
3 secondary outcomes
Parental preoperative anxiety
Time frame: during the preoperative day and the day of surgery
Preoperative anxiety in children
Time frame: During the day of surgery
Postoperative pain
Time frame: During the first 30 minutes in the post-anesthesia care unit (PACU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 15562048Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
- Results publication: PubMed 35544252Ali AB, Khan F. Emergence Delirium and Its Association with Preoperative Anxiety in Paediatric Patients Undergoing Infra Umbilical Surgery Under Combined General and Caudal Anaesthesia: An Observational Study from a Tertiary Care Centre in a South Asian Country. Turk J Anaesthesiol Reanim. 2022 Apr;50(2):129-134. doi: 10.5152/TJAR.2021.1104.
- Results publication: PubMed 38739185Alves CS, Dias J, Azevedo S, Sousa F, Santos M, Lino J, Meireles L. Keep Calm: Does parental preoperative anxiety affect post-tonsillectomy pain scores in children? Eur Arch Otorhinolaryngol. 2024 Aug;281(8):4385-4392. doi: 10.1007/s00405-024-08683-0. Epub 2024 May 13.
- Results publication: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Results publication: PubMed 37996779Yu H, Sun X, Li P, Deng X. Prevalence and risk factors of emergence agitation among pediatric patients undergo ophthalmic and ENT Surgery: a cross-sectional study. BMC Pediatr. 2023 Nov 24;23(1):598. doi: 10.1186/s12887-023-04434-y.
- The Association between Preoperative Parental Anxiety and Emergence Agitation in Preschoolers, 2017, Erkılıc, E. , Kesimci, E. , Doger, C. , Gumus, T. and Kanbak, O. , Open Journal of Epidemiology, 7, 18-26Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dilek Gemici, Specialist physician principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Agitation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 20 Mar 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of emergence agitation (time frame: From 1 to 30 minutes after extubation). 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 NCT07486427, which also lists 5 linked publications.
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 20 Mar 2026.