Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction

NCT ID: NCT06608550

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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For the child, the process of illness and hospitalization and the unknowns are the main cause of fear. In order to minimize children's fears, the procedures to be performed, the hospital environment should be introduced and the family should be informed about the process. Since the child's fear will also affect the family, involving the family in all processes enables the child and family to manage the current situation well. In the endoscopy procedure, in addition to the fear and anxiety caused by the procedure, opening an IV line before the procedure, not recognizing the environment where the procedure will be performed, being separated from the parents, not having information about the procedure, and receiving sedation are among the factors that will cause stress. For this reason, informing about the procedure, introducing the environment where the procedure will be performed, informing about the procedures before and during the procedure will ensure that this process is well managed and thus reduce fear and anxiety. Considering that fear and anxiety negatively affect the surgical procedure process, the rate of complications in the postoperative period of the child increases and the hospital stay is prolonged accordingly. 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 population of the study, which is planned as a randomized controlled experimental type study, will consist of children aged 9-12 years who apply to the pediatric gastroenterology outpatient clinic of Mersin University Hospital and will undergo endoscopy procedure. It was calculated that a total of 84 children, at least 41 in each group, should be included in the study with an effect size = 0.735, 95% confidence interval, and 95% power. Considering the possibility of drop outs and confounding variables in the research process, the number in the groups was increased by 10%. The sample of the study was determined as 90 children in total, 45 children in each group.

Randomization: In the study, 90 children in the sample will be randomly assigned to the control and short film viewing groups. Random assignment will be ensured by using a computer program to determine the group of 90 children in the sample.The data of the study will be collected using the following data collection tools:Introductory Information Form,Child Fear Scale,State Anxiety Scale for Children,Child Satisfaction Scale.

Conditions

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Fear Anxiety Children, Only Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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short video film

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.

Group Type EXPERIMENTAL

short video film

Intervention Type OTHER

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.

Control

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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short video film

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* The child has visual, hearing or intellectual disabilities,
* Previous endoscopy procedure
* The parent has undergone an endoscopy procedure
* Having a chronic disease
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tarsus University

OTHER

Sponsor Role lead

Responsible Party

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NARDANE BOLAT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atiye Karakul

Role: STUDY_DIRECTOR

Tarsus University

Locations

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Tarsus University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 38101311 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 24593951 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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2024/75

Identifier Type: -

Identifier Source: org_study_id

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