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

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05210829
Collaborator
(none)
120
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: stationary and trait anxiety scale

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy
Anticipated Study Start Date :
Jan 20, 2022
Anticipated Primary Completion Date :
Apr 20, 2022
Anticipated Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
High Parent Anxiety

Stationary and Trait Anxiety Scale ≥ 44 points

Diagnostic Test: stationary and trait anxiety scale
survey

Low Parent Anxiety

Stationary and Trait Anxiety Scale < 44 points

Diagnostic Test: stationary and trait anxiety scale
survey

Outcome Measures

Primary Outcome Measures

  1. Anesthesia agent dose [end of the gastrointestinal endoscopy]

Secondary Outcome Measures

  1. Children's anxiety [before gastrointestinal endoscopy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Erdoğan Öngel, Elif Erdogan-Ongel, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT05210829
Other Study ID Numbers:
  • Sancaktepe Pediatric Endoscopy
First Posted:
Jan 27, 2022
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022