FearNCT06608550
Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction
A study testing short video film in people with Fear and Anxiety, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Fear, Anxiety, Children, Only
- What is being tested?
- short video film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- The child has visual, hearing or intellectual disabilities,
- Previous endoscopy procedure
- The parent has undergone an endoscopy procedure
- Having a chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction Level in Children Undergoing Endoscopy Procedure
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.
Read the detailed 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.
- Conditions
- Fear, Anxiety, Children, Only, Satisfaction
- Being tested
- short video film
- Keywords
- fear, anxiety, satisfaction
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short video filmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start16 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NARDANE BOLAT, Tarsus University
- Investigators
- Atiye Karakul, Study director, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608550
- Sponsor's protocol ID
- 2024/75
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38101311Emara, 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.
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.
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.
PubMed 24593951Mohamed, 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction Level in Children Undergoing Endoscopy Procedure
- ClinicalTrials.gov ID
- NCT06608550
- Acronym / sponsor ID
- 2024/75
- Conditions
- Fear, Anxiety, Children, Only, Satisfaction
- Keywords
- fear, anxiety, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| short video film | Experimental | Other: short video filmChildren 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 | 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). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- The child has visual, hearing or intellectual disabilities,
- Previous endoscopy procedure
- The parent has undergone an endoscopy procedure
- Having a chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short video filmChildren 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 |
Primary outcome
anxiety level
Time frame: 1 day
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.
Fear level
Time frame: 1 day
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.
satisfaction level
Time frame: 1 day
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 38101311Bozkul 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.
- BackgroundEmara, 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.
- BackgroundHasasn 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: PubMed 24593951ASGE 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.
- BackgroundMohamed, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atiye Karakul study director
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short video film in people with Fear and Anxiety, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06608550, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.