Turkish Version of The Pediatric Anesthesia Emergency Delirium

NCT ID: NCT06931249

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-24

Study Completion Date

2025-08-30

Brief Summary

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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

Detailed Description

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Conditions

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Emergence Delirium, Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

The observational study

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Faruk Cicekci

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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Selcuk University

Identifier Type: OTHER

Identifier Source: secondary_id

farukcicekci8

Identifier Type: -

Identifier Source: org_study_id

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