Operative IncisionNCT05478369
The Effect of Reading Story Books on Fear and Anxiety Levels
A study testing storybook in people with Operative Incision, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to determine the effect of reading the story book, which is considered within the scope of the pedagogically approved research that introduces the surgical environment before the surgical intervention in children, on the pain and anxiety of the child. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Operative Incision
- What is being tested?
- storybook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2022to 19 Aug 2022
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 4-6
- Hernias, undescended testis surgery
- Does not have a disability related to developmental areas
- parent's literacy
Who cannot join
- Not between 4-6 years old
- No hernias, undescended testis surgery
- Having a disability related to developmental areas
- parent's illiteracy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Reading Story Books on Children's Preoperative Fear and Anxiety Levels
The aim of this project is to determine the effect of reading the story book, which is considered within the scope of the pedagogically approved research that introduces the surgical environment before the surgical intervention in children, on the pain and anxiety of the child. The project is a randomized controlled trial. The population of the research will be children between the ages of 4 and 6 who come to Atatürk University Health Research and Application Center Pediatric Surgery Clinic between March and September 2022 for treatment. The research sample; children and parents who are hospitalized in the clinic on the dates specified by the probabilistic sampling method and meet the research criteria, willing to participate in the research. "Survey Form", "Modified Yale Preoperative Anxiety Scale (mYPAS)" and "Child Fear Scale" will be used in data collection.
Read the detailed description
Type of Study: The study is of the randomized controlled experimental type. Place and Time of the Research: The research will be carried out between March-September 2022 at Atatürk University Health Research and Application Center Pediatric Surgery Clinic. Surgical procedures performed in the clinic are frequently prepuce, hernias, undescended testis, acute abdominal traumas and dilatation.
Population and Sample of the Study: The population of the research will be children aged 4-6 years who come to Atatürk University Health Research and Application Hospital Pediatric Surgery Clinic between March-September 2022 for treatment.
The research sample; hernia and undescended testis will be operated on the dates specified by the probabilistic sampling method and children who meet the research criteria and volunteer to participate in the research will be formed.
In order to prevent interaction between the groups of children in the clinic, data collection will not be carried out simultaneously in the story group and control groups. In order to ensure randomization, children who met the criteria will be included in the control group in the first week, and children who come in the second week will be included in the story group, and this cycle will be continued until the end of the study and randomization will be ensured.
Data Collection Tools: Questionnaire Form, Modified Yale Preoperative Anxiety Scale and Child Fear Scale will be used to collect research data. The book titled "Elif Is Surgery", which is licensed by Çamlıca Children's Publishing, which owns the copyrights, will be used as an intervention tool in the research.
Questionnaire Form: In this form, which was prepared by the researcher by examining the literature; There will be questions about the introductory features of the child and the parent.
Modified Yale Preoperative Anxiety Scale (mYPAS): The Yale Preoperative Anxiety Scale (YPAS), which was developed in 1995 to measure the preoperative anxiety of children, was modified in 1997 (mYPAS) and used in many studies covering various health fields such as dentistry, anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These; Activity includes speech, emotional state, marked arousal, and relationship with family. In the scale, the parameters of activity, emotional state, marked arousal state and relationship with family are evaluated between (1-4) and speech (1-6).
Child Fear Scale (CFS): Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
Intervention Tool to be Used in Research Storybook: As an intervention tool in the research, the book titled "Elif Is Surgery" will be read by her parents.
In the selection of the story book, attention was paid to the fact that it was pedagogically appropriate and at the same time the author of the book was a child developmentalist and pedagogue. In this storybook, the operating environment is introduced in a way that children can understand and is suitable for the age group of the study. Words such as cut and blood, which are specific to this age, are not used in the storybook. While the story book will be read, the child's opinion will be taken and the book will be read with a character name that he wants. For example, ask the children, "What name would you like to give your character before the book is read?" Asking the child's opinion will increase his self-confidence, and at the same time, it will be ensured that he listens carefully to the story with the curiosity of "What will happen to my character?" Data Collection The researcher will be in the pediatric surgery service for 2 days to examine the pediatric surgery service and will make a preliminary application before collecting the data of the children in the storybook group and the control group children. The children and their parents were given preliminary information about the research (the purpose of the research, why the research was conducted, the story book would be used to relieve the child's fear and anxiety, it was thought that it would be effective in preventing fear, etc.) will be obtained through face-to-face interviews.
Control Group: Questionnaires and scales will be filled by the researcher 30 minutes before the surgery. Only routine applications will be done within 5 minutes. The scales will be refilled 10 minutes before the surgery and when the child moves to the premedication room. The families of the children will be with the children until the premedication room. Filling out the forms will take 5-10 minutes on average.
Story Group: Questionnaires and scales will be filled in 30 minutes before the surgery by the researcher. The child's parent will read the storybook. In reading the story book; It will reduce fear and anxiety by attracting the patient's attention (sound, image…) and enabling him to get away from the negative emotions he is in. Routine applications will be done within 5 minutes. The scales will be refilled 10 minutes before the surgery and when the child moves to the premedication room. The families of the children will be with the children until the premedication room. Filling out the forms will take 5-10 minutes on average.
Evaluation of Data The processing and statistical analysis of the collected data will be done with the analysis software called SPSS (Statistical Package for the Social Sciences) for Windows 20.0.
Ethical Principles of Research In order to carry out the research, official permission from the relevant institution will be obtained from the Ethics Committee with ethical approval. Children who meet the criteria of the research group will be informed about the purpose of the study, their questions will be answered, and their verbal and written consent will be obtained. Parents and children will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed.
- Conditions
- Operative Incision
- Being tested
- storybook
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
storybookBehavioural
anxiety and fear during operative
| Study group | Role | What they receive |
|---|---|---|
| storybook | Experimental | anxiety and fear Receives: Behavioral: storybook |
| control | No intervention | not anxiety and fear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale (CFS)
The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
Measured: 9 MONTHS
Modified Yale Preoperative Anxiety Scale (mYPAS)
Yale Preoperative Anxiety Scale (YPAS), which was developed in 1995 to measure children's preoperative anxiety, was modified in 1997 (mYPAS) and used in many studies covering various health fields such as dentistry, anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These; Activity includes speech, emotional state, marked arousal, and relationship with family. In the scale, the parameters of activity, emotional state, marked arousal state, and family relationship are evaluated between (1-4) and speech (1-6).
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start19 Mar 2022
- Primary completion31 Jul 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Operative IncisionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478369
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/554
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Publications
Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.
PubMed 36735635
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reading Story Books on Children's Preoperative Fear and Anxiety Levels
- ClinicalTrials.gov ID
- NCT05478369
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/554
- Conditions
- Operative Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 28 Jul 2022 (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.
The aim of this project is to determine the effect of reading the story book, which is considered within the scope of the pedagogically approved research that introduces the surgical environment before the surgical intervention in children, on the pain and anxiety of the child. The project is a randomized controlled trial. The population of the research will be children between the ages of 4 and 6 who come to Atatürk University Health Research and Application Center Pediatric Surgery Clinic between March and September 2022 for treatment. The research sample; children and parents who are hospitalized in the clinic on the dates specified by the probabilistic sampling method and meet the research criteria, willing to participate in the research. "Survey Form", "Modified Yale Preoperative Anxiety Scale (mYPAS)" and "Child Fear Scale" will be used in data collection.
Detailed description
Type of Study: The study is of the randomized controlled experimental type. Place and Time of the Research: The research will be carried out between March-September 2022 at Atatürk University Health Research and Application Center Pediatric Surgery Clinic. Surgical procedures performed in the clinic are frequently prepuce, hernias, undescended testis, acute abdominal traumas and dilatation.
Population and Sample of the Study: The population of the research will be children aged 4-6 years who come to Atatürk University Health Research and Application Hospital Pediatric Surgery Clinic between March-September 2022 for treatment.
The research sample; hernia and undescended testis will be operated on the dates specified by the probabilistic sampling method and children who meet the research criteria and volunteer to participate in the research will be formed.
In order to prevent interaction between the groups of children in the clinic, data collection will not be carried out simultaneously in the story group and control groups. In order to ensure randomization, children who met the criteria will be included in the control group in the first week, and children who come in the second week will be included in the story group, and this cycle will be continued until the end of the study and randomization will be ensured.
Data Collection Tools: Questionnaire Form, Modified Yale Preoperative Anxiety Scale and Child Fear Scale will be used to collect research data. The book titled "Elif Is Surgery", which is licensed by Çamlıca Children's Publishing, which owns the copyrights, will be used as an intervention tool in the research.
Questionnaire Form: In this form, which was prepared by the researcher by examining the literature; There will be questions about the introductory features of the child and the parent.
Modified Yale Preoperative Anxiety Scale (mYPAS): The Yale Preoperative Anxiety Scale (YPAS), which was developed in 1995 to measure the preoperative anxiety of children, was modified in 1997 (mYPAS) and used in many studies covering various health fields such as dentistry, anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These; Activity includes speech, emotional state, marked arousal, and relationship with family. In the scale, the parameters of activity, emotional state, marked arousal state and relationship with family are evaluated between (1-4) and speech (1-6).
Child Fear Scale (CFS): Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
Intervention Tool to be Used in Research Storybook: As an intervention tool in the research, the book titled "Elif Is Surgery" will be read by her parents.
In the selection of the story book, attention was paid to the fact that it was pedagogically appropriate and at the same time the author of the book was a child developmentalist and pedagogue. In this storybook, the operating environment is introduced in a way that children can understand and is suitable for the age group of the study. Words such as cut and blood, which are specific to this age, are not used in the storybook. While the story book will be read, the child's opinion will be taken and the book will be read with a character name that he wants. For example, ask the children, "What name would you like to give your character before the book is read?" Asking the child's opinion will increase his self-confidence, and at the same time, it will be ensured that he listens carefully to the story with the curiosity of "What will happen to my character?" Data Collection The researcher will be in the pediatric surgery service for 2 days to examine the pediatric surgery service and will make a preliminary application before collecting the data of the children in the storybook group and the control group children. The children and their parents were given preliminary information about the research (the purpose of the research, why the research was conducted, the story book would be used to relieve the child's fear and anxiety, it was thought that it would be effective in preventing fear, etc.) will be obtained through face-to-face interviews.
Control Group: Questionnaires and scales will be filled by the researcher 30 minutes before the surgery. Only routine applications will be done within 5 minutes. The scales will be refilled 10 minutes before the surgery and when the child moves to the premedication room. The families of the children will be with the children until the premedication room. Filling out the forms will take 5-10 minutes on average.
Story Group: Questionnaires and scales will be filled in 30 minutes before the surgery by the researcher. The child's parent will read the storybook. In reading the story book; It will reduce fear and anxiety by attracting the patient's attention (sound, image…) and enabling him to get away from the negative emotions he is in. Routine applications will be done within 5 minutes. The scales will be refilled 10 minutes before the surgery and when the child moves to the premedication room. The families of the children will be with the children until the premedication room. Filling out the forms will take 5-10 minutes on average.
Evaluation of Data The processing and statistical analysis of the collected data will be done with the analysis software called SPSS (Statistical Package for the Social Sciences) for Windows 20.0.
Ethical Principles of Research In order to carry out the research, official permission from the relevant institution will be obtained from the Ethics Committee with ethical approval. Children who meet the criteria of the research group will be informed about the purpose of the study, their questions will be answered, and their verbal and written consent will be obtained. Parents and children will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| storybook | Experimental | Behavioral: storybookanxiety and fear |
| control | No intervention | –not anxiety and fear |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Between the ages of 4-6
- Hernias, undescended testis surgery
- Does not have a disability related to developmental areas
- parent's literacy
Key exclusion criteria (4 listed)
- Not between 4-6 years old
- No hernias, undescended testis surgery
- Having a disability related to developmental areas
- parent's illiteracy
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 |
|---|---|---|
| storybookanxiety and fear during operative | Behavioural | storybook |
Primary outcome
Child Fear Scale (CFS)
Time frame: 9 MONTHS
The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
Modified Yale Preoperative Anxiety Scale (mYPAS)
Time frame: 9 MONTHS
Yale Preoperative Anxiety Scale (YPAS), which was developed in 1995 to measure children's preoperative anxiety, was modified in 1997 (mYPAS) and used in many studies covering various health fields such as dentistry, anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These; Activity includes speech, emotional state, marked arousal, and relationship with family. In the scale, the parameters of activity, emotional state, marked arousal state, and family relationship are evaluated between (1-4) and speech (1-6).
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 27 Oct 2022.
- Derived from this study: PubMed 36735635Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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.
ARZU SARIALİOĞLU, PHD study director
Ataturk 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 storybook in people with Operative Incision, run by Ataturk 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 4 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 27 Oct 2022. 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?
Child Fear Scale (CFS) (time frame: 9 MONTHS). The study lists 2 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 NCT05478369, which also lists 1 linked publication.
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 27 Oct 2022.