NCT06608550

Brief Summary

It was planned as a randomized controlled experimental study to examine the effect of short film video training before the endoscopy procedure on the child's fear, anxiety and satisfaction level in children who will undergo endoscopy procedure. The study will be conducted with children aged 9-12 years who applied to Mersin University Hospital Pediatric Gastroenterology Outpatient Clinic for endoscopy procedure. After obtaining written informed consent from the parents of the child who will undergo endoscopy, what will be done before the endoscopy procedure will be explained to the parent. Then a descriptive information form will be filled. Physiologic parameters (pulse, blood pressure, respiration, SPO2) will be measured before and after the procedure. The parent, nurse and the child themselves will evaluate the fear and anxiety score before and after the procedure, the satisfaction level will be determined by the child himself/herself and recorded on the follow-up form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

September 19, 2024

Last Update Submit

January 5, 2026

Conditions

Keywords

fearanxietysatisfaction

Outcome Measures

Primary Outcomes (3)

  • anxiety level

    State Anxiety Scale for Children: The 40-question items in the scale were divided into 20 state and 20 trait anxiety items and turned into two scales. The highest score that can be obtained for the State Anxiety Scale is 60 and the lowest score is 20. Cronbach's α value was found to be 0.82.

    1 day

  • Fear level

    Scary Scale:The scale consists of six facial expressions. These facial expressions rate fear with a score ranging from 0 to 10 (gradually increasing by two), consistent with pain rating scales. The first facial expression indicates that I am not afraid at all, the fear increases from right to left, and the sixth, the last facial expression indicates that I am very afraid.

    1 day

  • satisfaction level

    Child Satisfaction Scale: The numbers between 0 and 10, which the children would indicate by circling the point corresponding to their satisfaction with the education given, were placed on a horizontal line. In this scale, a score of 0 indicates "not satisfied at all", while a score of 10 indicates "extremely satisfied".

    1 day

Study Arms (2)

short video film

EXPERIMENTAL

Children will be trained with a short movie to prepare for the endoscopy procedure. The content of the short movie video training will include; introduction of the outpatient clinic, things to be considered before the procedure, preparation for the procedure, introduction of the endoscopy room, introduction of the service to come after endoscopy, issues to be considered after the procedure. The short movie training is expected to last approximately 5 minutes.

Other: short video film

Control

NO INTERVENTION

Routine practice of the clinic (in routine practice; verbal information is given with the information and consent form prepared on the definition of endoscopy, the purpose of the procedure, the risks of the procedure, and what to pay attention to after the procedure).

Interventions

Children will be trained with a short movie to prepare for the endoscopy procedure. The content of the short movie video training will include; introduction of the outpatient clinic, things to be considered before the procedure, preparation for the procedure, introduction of the endoscopy room, introduction of the service to come after endoscopy, issues to be considered after the procedure. The short movie training is expected to last approximately 5 minutes.

short video film

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group between 9 and 12,
  • No communication problems (visual/auditory/mental),
  • Speaking and writing in Turkish
  • Endoscopy procedure being applied for the first time
  • The fact that the procedure will be applied to the child with sedation
  • Voluntariness of the parent and child to participate in the study

You may not qualify if:

  • The child has visual, hearing or intellectual disabilities,
  • Previous endoscopy procedure
  • The parent has undergone an endoscopy procedure
  • Having a chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Turkey (Türkiye)

Location

Related Publications (5)

  • Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.

    PMID: 38101311BACKGROUND
  • Emara, H. M., Khalifa, M. I., Okby, O. M., Yonis, J. R., & Basiouny, H. E. M. (2022). Effect of Developmental Psychological Preparation on Behavioral Distress of Children Undergoing Endoscopy. Menoufia Nursing Journal, 7(1), 413-427.

    BACKGROUND
  • Hasasn Tehrani, T., Pakzad, A., Mohammadi, F., Tapak, L., & Azmamoun, H. (2022). Effect of Pre-endoscopy Preparation Program on Children's Anxiety and Parental Satisfaction: A Clinical Trial Study. Evidence Based Care, 11(4), 48-54.

    BACKGROUND
  • ASGE Standards of Practice Committee; Lightdale JR, Acosta R, Shergill AK, Chandrasekhara V, Chathadi K, Early D, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Kashab M, Muthusamy VR, Pasha S, Saltzman JR, Cash BD; American Society for Gastrointestinal Endoscopy. Modifications in endoscopic practice for pediatric patients. Gastrointest Endosc. 2014 May;79(5):699-710. doi: 10.1016/j.gie.2013.08.014. Epub 2014 Mar 1.

    PMID: 24593951BACKGROUND
  • Mohamed, A. E. G., Hassan, A., & Elsayed Metwally, H. (2023). Effect of Calming Techniques on Health Parameters of Children Undergoing Upper Gastrointestinal Endoscopy and their Mothers' Satisfaction. Egyptian Journal of Health Care, 14(2), 916-932.

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Atiye Karakul

    Tarsus University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: In the study, 90 children in the sample will be randomly assigned to the control and short film viewing groups. In determining the group of 90 children in the sample, random assignment will be made using a computer program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

May 16, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations