Emergence Delirium, AnesthesiaPAEDNCT06931249
Turkish Version of The Pediatric Anesthesia Emergency Delirium
An observational study of Emergence Delirium, Anesthesia, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Emergence delirium (ED) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium, Anesthesia
- What is being tested?
- The observational study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 385 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2025to 30 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: In patients admitted to the Postoperative Anesthesia Recovery Unit (PACU) after general anesthesia for elective pediatric surgery
Who may be able to join
- Parents consented to the study,
- Transferred to PACU after general anesthesia,
- Between 2-16 years of age,
- ASA physical status class I-II,
- Cognitively intact children.
Who cannot join
- Children without parental consent,
- Children under 2 years of age and over 16 years of age,
- Children with ASA physical status class III and above,
- Children who underwent surgery under general anesthesia under emergency conditions,
- Children with cognitive and behavioral disorders,
- Children who developed major complications after the operation,
- Children who are expected to require postoperative mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of The Pediatric Anesthesia Emergency Delirium (PAED) Scale: Translation and Cross-Cultural Adaptation
Emergence delirium (ED) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. The aim of this study is to translate and adapt the PAED scale to Turkish.
A five-stage translation and adaptation process will be performed. The reliability of the Turkish version of the PAED scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ED was defined by a cut-off point of ≥ 10 points on the PAED scale
- Conditions
- Emergence Delirium, Anesthesia
- Being tested
- The observational study
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The observational studyBehavioural
This study is being conducted to create a Turkish version of the English version of the PAED scale, which did not exist before, and to determine its cultural suitability.
| Study group | Role | What they receive |
|---|---|---|
| To make a Turkish version of the English version of the PAED scale, to determine it as a culturally | Translation and cross-cultural adaptation of the PAED scale In Phase 1 (translation), the PAED scale will first be translated into Turkish by three anesthesiologists who are fluent in English.
In Phase 2 (synthesis), the three translated versions will be combined into a single version.
In Phase 3 (back translation to English), an English expert who is fluent in Turkish will independently perform the back translation.
In Phase 4 (expert committee review), the final version of the scale will be evaluated by all raters.
In Phase 5 (pre-test), anesthesiologists will be contacted through the branch association to ask about the importance and acceptability of the scale in clinical settings and to evaluate the accuracy and comprehensibility of the scale.
In Phase 6 (Integration), it will be evaluated by all authors and integrated into the final version of the scale. Receives: Behavioral: The observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish version of the pediatric anesthesia emergency delirium (PAED) scale
The PAED scale consists of the following 5 items; 1- degree of eye contact, 2- purposeful actions, 3- awareness of the environment, 4- restlessness and 5- inconsolability. Each item is assigned a score between 0 and 4,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start24 Mar 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium, AnesthesiaStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Other
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931249
- Sponsor's protocol ID
- farukcicekci8
- Other IDs
- Selcuk University
- Acronym
- PAED
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of The Pediatric Anesthesia Emergency Delirium (PAED) Scale: Translation and Cross-Cultural Adaptation
- ClinicalTrials.gov ID
- NCT06931249
- Acronym / sponsor ID
- PAED / farukcicekci8
- Conditions
- Emergence Delirium, Anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Apr 2025 (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) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. The aim of this study is to translate and adapt the PAED scale to Turkish.
A five-stage translation and adaptation process will be performed. The reliability of the Turkish version of the PAED scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ED was defined by a cut-off point of ≥ 10 points on the PAED scale
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To make a Turkish version of the English version of the PAED scale, to determine it as a culturally | – | Behavioral: The observational studyTranslation and cross-cultural adaptation of the PAED scale In Phase 1 (translation), the PAED scale will first be translated into Turkish by three anesthesiologists who are fluent in English. In Phase 2 (synthesis), the three translated versions will be combined into a single version. In Phase 3 (back translation to English), an English expert who is fluent in Turkish will independently perform the back translation. In Phase 4 (expert committee review), the final version of the scale will be evaluated by all raters. In Phase 5 (pre-test), anesthesiologists will be contacted through the branch association to ask about the importance and acceptability of the scale in clinical settings and to evaluate the accuracy and comprehensibility of the scale. In Phase 6 (Integration), it will be evaluated by all authors and integrated into the final version of the scale. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- In patients admitted to the Postoperative Anesthesia Recovery Unit (PACU) after general anesthesia for elective pediatric surgery
Key inclusion criteria (5 listed)
- Parents consented to the study,
- Transferred to PACU after general anesthesia,
- Between 2-16 years of age,
- ASA physical status class I-II,
- Cognitively intact children.
Key exclusion criteria (7 listed)
- Children without parental consent,
- Children under 2 years of age and over 16 years of age,
- Children with ASA physical status class III and above,
- Children who underwent surgery under general anesthesia under emergency conditions,
- Children with cognitive and behavioral disorders,
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 |
|---|---|---|
| The observational studyThis study is being conducted to create a Turkish version of the English version of the PAED scale, which did not exist before, and to determine its cultural suitability. | Behavioural | To make a Turkish version of the English version of the PAED scale, to determine it as a culturally |
Primary outcome
Turkish version of the pediatric anesthesia emergency delirium (PAED) scale
Time frame: 6 months
The PAED scale consists of the following 5 items; 1- degree of eye contact, 2- purposeful actions, 3- awareness of the environment, 4- restlessness and 5- inconsolability. Each item is assigned a score between 0 and 4,
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 17 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Emergence Delirium, Anesthesia, run by Selcuk 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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 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 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?
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?
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?
Turkish version of the pediatric anesthesia emergency delirium (PAED) scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.