NCT06071390

Brief Summary

The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

September 27, 2023

Last Update Submit

October 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • changing the anxiety

    Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.

    'Before watching video' and 'After watching video, within 5 minutes'

  • changing the fear

    The Children's Fear Scale (CFS) was developed by Chambers et al. in 2011. It was adapted into Turkish by Gerceker et al. in 2018. It comprises five facial expressions ranging from neutral to extreme fear. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures. This scale provides scores ranging from 0-4. As the score increases, the level of fear increases.

    'Before watching video' and 'After Watching Video, within 5 minutes'

Study Arms (2)

Children watching animated- assisted video before endoscopy procedure

EXPERIMENTAL

Inclusion criteria were children and mothers who voluntarily participated, who were aged 6-12 years, who know Turkish, and who do not have a vision or mental problem at a level to watch the image.

Behavioral: Animated- assisted video

Children not watching animated- assisted video before endoscopy procedure

NO INTERVENTION

Exclusion criteria were children and mothers who not voluntarily participated, who were not aged 6-12 years, who don't know Turkish, and who have a vision or mental problem at a level to watch the image.

Interventions

For the experimental group, 15 minutes prior to the endoscopy, the researcher provided insight into the procedure by showing them a 3-minute animated video titled "Endocan." This video, crafted by Köse in 2019 for his doctoral dissertation, offers a succinct overview of the endoscopy procedure.

Children watching animated- assisted video before endoscopy procedure

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and mothers who voluntarily participated,
  • who were aged 6-12 years,
  • who know Turkish,
  • who do not have a vision or mental problem at a level to watch the image.

You may not qualify if:

  • children and mothers who not voluntarily participated,
  • who were not aged 6-12 years,
  • who don't know Turkish,
  • who have a vision or mental problem at a level to watch the image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (3)

  • Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4.

    PMID: 32056813BACKGROUND
  • Arican, Ş., Yücel, A., Yılmaz, R., Hacıbeyoğlu, G., Yusifov, M., Yüce, S., Topal, A.(2020). Anxiety level and risk factors among pediatric patients in endoscopic procedures outside the operating room: A cross-sectional study. J Surg Med, 4(8), 693-697.

    BACKGROUND
  • Camur Z, Sarikaya Karabudak S. The effect of parental participation in the care of hospitalized children on parent satisfaction and parent and child anxiety: Randomized controlled trial. Int J Nurs Pract. 2021 Oct;27(5):e12910. doi: 10.1111/ijn.12910. Epub 2020 Dec 16.

    PMID: 33331038BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 6, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

other researchers may view the study once it is published.

Locations