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

NCT05210829 | Unknown

• 1 other identifier: Sancaktepe Pediatric Endoscopy
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Anesthesia agent dose

  end of the gastrointestinal endoscopy

Secondary Outcomes (1)

• Children's anxiety

  before gastrointestinal endoscopy

Study Arms (2)

High Parent Anxiety

Stationary and Trait Anxiety Scale ≥ 44 points

Diagnostic Test: stationary and trait anxiety scale

Low Parent Anxiety

Stationary and Trait Anxiety Scale \< 44 points

Diagnostic Test: stationary and trait anxiety scale

Interventions

stationary and trait anxiety scale DIAGNOSTIC_TEST

survey

High Parent Anxiety; Low Parent Anxiety

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Elif Erdogan-Ongel

CONTACT

00902166063300; dreliferdogan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elif Erdogan-Ongel

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 20, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01