NCT06602791

Brief Summary

Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on preoperative anxiety levels in pediatric endoscopy patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

September 17, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

anesthesiaanxietyshort videospediatric endoscopy

Outcome Measures

Primary Outcomes (1)

  • Modified Yale Preoperative Anxiety Scale (mYPAS) scores

    Anxiety scores assessed and recorded at six distinct time points-namely, entry to the pre-procedural preparation room (T1), exit from the pre-procedural preparation room (T2), in the procedure room (T3), entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and exit from the recovery unit (T6)-constitute the primary outcome of the study.

    1 hour

Secondary Outcomes (1)

  • Recovery Time

    1 hour

Study Arms (2)

Video Group

Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone or tablet for 20 minutes under the guidance of their parents.

Control Group (Standard)

The control group will undergo standard preoperative preparation. Patients in this group will not watch any videos.

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II will be enrolled.

You may qualify if:

  • Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II

You may not qualify if:

  • Patients under 5, over 12, or with ASA score \>2
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Caner Genc, M.D.

    Samsun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

September 17, 2024

Primary Completion

November 27, 2024

Study Completion

December 4, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations