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

T

Tarsus University

Status

Completed

Conditions

Fear
Satisfaction
Children, Only
Anxiety

Treatments

Other: short video film

Study type

Interventional

Funder types

Other

Identifiers

NCT06608550
2024/75

Details and patient eligibility

About

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.

Full description

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.

Enrollment

90 patients

Sex

All

Ages

9 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

short video film
Experimental group
Description:
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.
Treatment:
Other: short video film
Control
No Intervention group
Description:
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).

Trial contacts and locations

1

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Central trial contact

Atiye Karakul, Assoc. Prof; Nardane Bolat

Data sourced from clinicaltrials.gov

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