Turkish Version of The Pediatric Anesthesia Emergency Delirium

NCT06931249 | Active Not Recruiting

• 2 other identifiers: farukcicekci8Selcuk University
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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,

  6 months

Study Arms (1)

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.

Behavioral: The observational study

Interventions

The observational study BEHAVIORAL

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.

To make a Turkish version of the English version of the PAED scale, to determine it as a culturally

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

In patients admitted to the Postoperative Anesthesia Recovery Unit (PACU) after general anesthesia for elective pediatric surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, 42250, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 17, 2025
• Study Start: March 24, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)