The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy

NCT ID: NCT05210829

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-04-20

Brief Summary

Our study was planned as a prospective, single-center study between 20 January 2022 and 20 April 2022. All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study. All patients and parents whose family did not give consent to participate in the study will be excluded from the study. All patients will be seen by an anesthesiologist before the procedure and it will be stated that there is no harm in taking anesthesia. Anesthesia consent form will be given by the family. Study participation consent will be obtained from parents before starting the procedure. The patient's age, gender, height, weight, ASA score, the procedure to be performed, the parent's educational status, occupation and income level will be recorded. Children's anxiety will be evaluated with the "Modified Yale Preoperative Anxiety Scale (mYPAS)" in the presence of their parents 15-30 minutes before the procedure. The agitation that occurs when the patient leaves the families for processing, with the "Parental Separation Anxiety Scale"; Parental anxiety will be evaluated with the "Stationary and Trait Anxiety Scale" filled by families after the child is processed.

Conditions

Anxiety; Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High Parent Anxiety

Stationary and Trait Anxiety Scale ≥ 44 points

stationary and trait anxiety scale

Intervention Type: DIAGNOSTIC_TEST

survey

Low Parent Anxiety

Stationary and Trait Anxiety Scale \< 44 points

stationary and trait anxiety scale

Intervention Type: DIAGNOSTIC_TEST

survey

Interventions

stationary and trait anxiety scale

survey

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study.

Exclusion Criteria

• All patients and parents whose family did not give consent to participate in the study will be excluded from the study.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Elif Erdoğan Öngel

Elif Erdogan-Ongel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elif Erdogan-Ongel

Role: CONTACT

dreliferdogan@gmail.com

00902166063300

Other Identifiers

Sancaktepe Pediatric Endoscopy

Identifier Type: -

Identifier Source: org_study_id