Turkish Version of The Pediatric Anesthesia Emergency Delirium (PAED)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Emergence Delirium, Anesthesia
• Intervention / Treatment: Behavioral: The observational study

• Study Type: Observational
• Enrollment (Actual): 385

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42250
    • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Parents consented to the study,
2. Transferred to PACU after general anesthesia,
3. Between 2-16 years of age,
4. ASA physical status class I-II,
5. Cognitively intact children.

Exclusion Criteria:

1. Children without parental consent,
2. Children under 2 years of age and over 16 years of age,
3. Children with ASA physical status class III and above,
4. Children who underwent surgery under general anesthesia under emergency conditions,
5. Children with cognitive and behavioral disorders,
6. Children who developed major complications after the operation,
7. Children who are expected to require postoperative mechanical ventilation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Selcuk University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: farukcicekci8; Selcuk University (Other Identifier: Selcuk University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No