Postoperative PainNCT07343388
Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery
An observational study of Postoperative Pain and Preoperative Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy… Read more about this study
- Who is it for?
- Ages 2 to 7 years, men only
- Conditions the study is for
- Postoperative Pain, Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia
- What is being tested?
- Standardized Perioperative Management and Observational Assessment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Mar 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 years
- Men only
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients aged 2 to 7 years who are scheduled for elective urogenital surgical procedures at a tertiary pediatric training and research hospital. The cohort specifically focuses on patients undergoing common inguinoscrotal surgeries, including hypospadias repair, orchidopexy, and hydrocele surgery, under standardized general anesthesia. Participants are selected from patients who meet the ASA I-II physical status criteria and have no underlying neurological or psychiatric conditions that could interfere with anxiety and delirium assessments.
Who may be able to join
- Male patients aged 2 to 7 years.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Scheduled for elective urogenital surgery, specifically hypospadias repair, orchidopexy, or hydrocele surgery.
- Scheduled to undergo general anesthesia for the procedure.
- Patients with no history of neurological or psychiatric disorders.
- Provision of written informed consent by the parents or legal guardians.
Who cannot join
- Patients outside the specified age range (younger than 2 or older than 7 years).
- Female patients.
- Patients undergoing emergency surgeries or non-urogenital/non-inguinal procedures.
- Presence of a diagnosed cognitive impairment or developmental delay.
- Parental or legal guardian refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Children's Hospital
Izmir, Konak, 35210
About this study
Official title: Evaluation of the Impact of Preoperative Anxiety on Postoperative Pain and Emergence Delirium in Patients Undergoing Pediatric Urogenital Surgery: A Prospective Observational Study
The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy, and hydrocele surgery.
The main questions it aims to answer are:
Read more
Does a higher level of preoperative anxiety lead to increased postoperative pain and a higher incidence of emergence delirium?
Is there a significant relationship between preoperative anxiety and the speed of physical recovery (discharge readiness) as measured by Aldrete scores?
Researchers will compare outcomes of patients with different levels of preoperative anxiety to see if higher anxiety results in poorer recovery profiles in the immediate postoperative period.
Participants will:
Be assessed for anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS) immediately before anesthesia induction.
Undergo a standardized anesthesia protocol for their elective urogenital procedure (hypospadias repair, orchidopexy, or hydrocele surgery).
Be monitored in the Post-Anesthesia Care Unit (PACU) at 0, 15, 30, 45, and 60 minutes after surgery to evaluate physical recovery (Modified Aldrete Score), delirium (PAED scale), and pain intensity (FLACC scale).
- Conditions
- Postoperative Pain, Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia, Urogenital Diseases
- Being tested
- Standardized Perioperative Management and Observational Assessment
- Keywords
- preoperative anxiety, postoperative pain, Postoperative Complications, mYPAS, FLACC Scale, Aldrete Score, PAED Scale
- Medical subject headings
- Pain, Postoperative, Urogenital Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Perioperative Management and Observational AssessmentOther
All participants will undergo a standardized general anesthesia protocol for elective urogenital surgery (hypospadias repair, orchidopexy, or hydrocele surgery). The intervention includes:
Preoperative Phase: Assessment of anxiety using the mYPAS scale before induction.
Intraoperative Phase: Standardized induction and maintenance of anesthesia (e.g., inhalational anesthesia with sevoflurane).
Postoperative Phase: Systematic observation in the Post-Anesthesia Care Unit (PACU) using Modified Aldrete, PAED, and FLACC scales at 0, 15, 30, 45, and 60 minutes. No experimental drugs or techniques will be administered; the study focuses on the observational correlation between preoperative anxiety and recovery outcomes."
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Urogenital Surgery Group | Not described Receives: Other: Standardized Perioperative Management and Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort).
Measured: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Incidence and Severity of Emergence Delirium
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium.
Measured: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Secondary outcomes (1)
Postoperative Physical Recovery and Discharge Readiness
Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge.
Measured: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Responsible party
- Principal investigator, Gonul Sari, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343388
- Sponsor's protocol ID
- GOA-155
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Topalel S, Orekici Temel G, Azizoglu M. Evaluation of Preoperative Anxiety in Turkish Paediatric Patients and Validity and Reliability of the Turkish Modified Yale Preoperative Anxiety Scale. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):484-490. doi: 10.5152/TJAR.2020.116. Epub 2020 May 18.
PubMed 33313588
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Preoperative Anxiety on Postoperative Pain and Emergence Delirium in Patients Undergoing Pediatric Urogenital Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07343388
- Acronym / sponsor ID
- GOA-155
- Conditions
- Postoperative Pain, Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia, Urogenital Diseases
- Keywords
- preoperative anxiety, postoperative pain, Postoperative Complications, mYPAS, FLACC Scale, Aldrete Score, PAED Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy, and hydrocele surgery.
The main questions it aims to answer are:
Does a higher level of preoperative anxiety lead to increased postoperative pain and a higher incidence of emergence delirium?
Is there a significant relationship between preoperative anxiety and the speed of physical recovery (discharge readiness) as measured by Aldrete scores?
Researchers will compare outcomes of patients with different levels of preoperative anxiety to see if higher anxiety results in poorer recovery profiles in the immediate postoperative period.
Participants will:
Be assessed for anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS) immediately before anesthesia induction.
Undergo a standardized anesthesia protocol for their elective urogenital procedure (hypospadias repair, orchidopexy, or hydrocele surgery).
Be monitored in the Post-Anesthesia Care Unit (PACU) at 0, 15, 30, 45, and 60 minutes after surgery to evaluate physical recovery (Modified Aldrete Score), delirium (PAED scale), and pain intensity (FLACC scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Urogenital Surgery Group | – | Other: Standardized Perioperative Management and Observational Assessment |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients aged 2 to 7 years who are scheduled for elective urogenital surgical procedures at a tertiary pediatric training and research hospital. The cohort specifically focuses on patients undergoing common inguinoscrotal surgeries, including hypospadias repair, orchidopexy, and hydrocele surgery, under standardized general anesthesia. Participants are selected from patients who meet the ASA I-II physical status criteria and have no underlying neurological or psychiatric conditions that could interfere with anxiety and delirium assessments.
Key inclusion criteria (6 listed)
- Male patients aged 2 to 7 years.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Scheduled for elective urogenital surgery, specifically hypospadias repair, orchidopexy, or hydrocele surgery.
- Scheduled to undergo general anesthesia for the procedure.
- Patients with no history of neurological or psychiatric disorders.
Key exclusion criteria (5 listed)
- Patients outside the specified age range (younger than 2 or older than 7 years).
- Female patients.
- Patients undergoing emergency surgeries or non-urogenital/non-inguinal procedures.
- Presence of a diagnosed cognitive impairment or developmental delay.
- Parental or legal guardian refusal to provide informed consent.
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 |
|---|---|---|
| Standardized Perioperative Management and Observational AssessmentAll participants will undergo a standardized general anesthesia protocol for elective urogenital surgery (hypospadias repair, orchidopexy, or hydrocele surgery). The intervention includes: Preoperative Phase: Assessment of anxiety using the mYPAS scale before induction. Intraoperative Phase: Standardized induction and maintenance of anesthesia (e.g., inhalational anesthesia with sevoflurane). Postoperative Phase: Systematic observation in the Post-Anesthesia Care Unit (PACU) using Modified Aldrete, PAED, and FLACC scales at 0, 15, 30, 45, and 60 minutes. No experimental drugs or techniques will be administered; the study focuses on the observational correlation between preoperative anxiety and recovery outcomes." | Other | Pediatric Urogenital Surgery Group |
Primary outcome
Postoperative Pain Intensity
Time frame: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort).
Incidence and Severity of Emergence Delirium
Time frame: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium.
1 secondary outcome
Postoperative Physical Recovery and Discharge Readiness
Time frame: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33313588Topalel S, Orekici Temel G, Azizoglu M. Evaluation of Preoperative Anxiety in Turkish Paediatric Patients and Validity and Reliability of the Turkish Modified Yale Preoperative Anxiety Scale. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):484-490. doi: 10.5152/TJAR.2020.116. Epub 2020 May 18.
- 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.
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?
An observational study of Postoperative Pain and Preoperative Anxiety, run by Aydin Adnan Menderes 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 6 inclusion and 5 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 24 Apr 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?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain Intensity (time frame: Postoperatively at 0, 15, 30, 45, and 60 minutes.). The study lists 2 primary outcomes in all. 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 NCT07343388, 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 Apr 2026.