Preoperative AnxietyNCT06399016
Augmented Reality Applied Book Reading in the Preoperative Period
A study testing augmented reality book and book in people with Preoperative Anxiety, run by Manisa Celal Bayar University at 2 sites in Turkey (Türkiye).
Trial summary
Non-pharmacological methods such as multimedia applications and visual and auditory technological tools are used to create a more enjoyable experience by reducing children's fear and anxiety and distracting them in the preoperative period. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- augmented reality book and book
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 May 2024to 30 Nov 2024
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between the ages of 7-12
- Children who will undergo surgery for the first time will be included
- No communication problems (vision, hearing, mental),
- Both his/her parents volunteer to participate in the research, and their parents give written and verbal consent,
Who cannot join
- Children have genetic or congenital disease,
- Children have a chronic disease
- Children have previous surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Manisa Hafsa Sultan Hospital
Manisa
Surgical clinic of Manisa Celal Bayar University Hospital
Manisa
About this study
Official title: The Effect of Reading a Book With Augmented Reality Application on the Level of Fear and Anxiety in Children in the 7-12 Age Group in the Preoperative Period
Non-pharmacological methods such as multimedia applications and visual and auditory technological tools are used to create a more enjoyable experience by reducing children's fear and anxiety and distracting them in the preoperative period. With the latest developments in technology, live, immersive, augmented and virtual reality systems are seen to be included and used in preoperative preparation training, especially for pediatric patients. One of the applications of these innovative technologies that has attracted attention recently is augmented reality technology. The original value of this study is to reduce the fear and anxiety levels experienced by children reading books in the preoperative period with the application of augmented reality, which is a developing, promising and easily accessible technology. The method of this study consists of two groups: an augmented reality applied book reading group and a control group. In the preoperative period for both groups, a survey will be administered to the child and the accompanying parent using the "Child and Family Introductory Data Form", which includes sociodemographic characteristics, approximately 1 hour before the surgery. In addition, the child himself will be asked to score the "Child Anxiety Scale-State" scale to determine the level of anxiety about the surgery, and the child himself, the parent and the researcher will be asked to score the "Child Fear Scale" to determine the child's level of fear about the surgery. The book reading group with augmented reality application will be asked to read the voiced and animated book titled 'One Child, One Miracle', accompanied by an application downloaded free of charge from Google Play or IOS to their mobile phone or tablet. The storybook will be presented to the children in this application group in three dimensions with the help of a mobile phone or tablet. Children in the control group will read the same book without using the augmented reality application. After reading the book for both groups, the children will be asked to rate their fear and anxiety levels again using the same scales. This research is a randomized controlled and experimental study. The adequacy of the sample size in the study "G. It was calculated using the "Power-3.1.9.2" program. In the power analysis conducted for the sample and power calculation of the experimental study with the application and control groups, it was decided to study with 30 children for each group.
Read the detailed description
During hospitalization and exposure to medical procedures and surgical procedures, children perceive themselves as different from other children and experience feelings of inadequacy and feel hindered. Especially for school-age children aged 7-12, hospitalization means a process full of worries that cause anxiety and fear. In a study investigating the feelings of hospitalized children aged 7-12 about "hospital" and "disease", it was observed that children defined the hospital as a place where pain and painful procedures are performed most often, causing both themselves and their parents to be upset, and where they experience fear and anxiety. Because the hospital environment, staff, materials used and procedures to be performed are reflected as a state of uncertainty for every group of children hospitalized. This uncertainty they experience may affect the child's adaptation to the hospital and treatment, his communication with healthcare personnel, and his future hospital experience. Having an additional surgical intervention on the child in addition to hospitalization causes more stress and affects the child more both psychologically and physiologically. In a study, the psychosocial symptoms of 360 hospitalized children aged 6-12 were examined in terms of some variables. It has been determined that more than half of the children develop "anxiety" due to hospitalization, along with "regression", "communication difficulty", "hopelessness" and "anger" behaviors. In another study examining postoperative behavioral changes in Chinese children who underwent hypospadias surgery, it was determined that three-fifths of the children showed behavioral changes that lasted for several weeks after surgery.
The success of surgery in children is not only related to the importance of the techniques and skills applied, but also to the preparation of the child and the parent and meeting the care needs in the preoperative period. Preparing the child patient appropriately in the preoperative period prevents him from experiencing both behavioral and physiological symptoms of fear and anxiety. Studies have shown that more than 60% of children who undergo surgery experience anxiety before surgery and anesthesia. However, in children who were psychologically affected in the preoperative period, maladaptive behavioral changes such as anxiety, eating and sleeping disorders, nightmares, enuresis and tantrums occurred in the postoperative period. Some intervention practices have been developed to reduce preoperative fear and anxiety in children and to prevent anxiety-related behavioral changes. These practices include various behavioral preparation programs used to distract from nonpharmacological practices. Such approaches help children to divert their attention from fearful and painful procedures by keeping them active. In methods of diverting attention; Methods such as daydreaming, listening to music, hypnosis, relaxation techniques, breathing control, biofeedback exercises, watching videos, reading books, telling stories and games are used. In a study, it was observed that children aged 4-10 years of age reduced their stress, their parents' anxiety, and postoperative delirium by providing distraction via tablets and phones in the preoperative period, and increased cooperation with medical personnel during anesthesia induction. The preparations to be made according to the child's age, period characteristics and understanding capacity should be explained to the child so that he/she does not feel afraid. Because preoperative anxiety is associated with an increased incidence of delirium, pain, and postoperative maladaptive behavior in the child. It can also manifest itself in various ways such as agitation, crying, shaking, struggle and escape behaviors. Therefore, the main goal in preparing for the surgery process is to maintain the child-parent relationship, reduce fears and anxiety arising from the unknown, and psychologically support the child and parents. Preoperative interventions have been increasingly used in hospital settings over the past few years. It has been observed that fear and anxiety arising from the preoperative period in children, video glasses, video displaying smartphones and tablets reduce postoperative delirium.
Hypothesis of the Research:
Hypothesis 1. H1: Reading books with augmented reality application in the preoperative period reduces the level of fear in children aged 7-12.
Hypothesis 2. H1: Reading books with augmented reality application in the preoperative period reduces the anxiety level in children aged 7-12.
- Conditions
- Preoperative Anxiety
- Being tested
- augmented reality book, book
- Keywords
- Child, fear, anxiety, operating theater tour, augmented reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmented reality bookDevice
Also called Augmented reality applied book titled 'One Child, One Miracle'
The story will be presented to the children in this application group in three dimensions. The augmented reality application will be supported by the researcher as it must be used under the supervision of an adult. When the tablet or phone is held to the pages of the book, the animations of these pages are displayed on the screen with sound. While the animation opens automatically when we hold the phone or tablet, the story can be listened to aloud at the same time.
bookDevice
Also called 'One Child, One Miracle'
This group will be asked to just read the book without turning on the augmented reality feature of the book.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Augmented Reality Applied Book Reading Group | Experimental | Children included in this group will be asked to read books supported by augmented reality technology. Approximately 1 hour before the surgery, a survey will be administered to the child and the accompanying parent using the "Child and Family Introductory Data Form", which includes sociodemographic characteristics. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. Data collection will take approximately 10 minutes in total. Immediately afterwards, the researcher will ask the child to read the book 'One Child, One Miracle', which is a technology-supported augmented reality application, with the help of an application previously downloaded free of charge from Google Play or IOS to a mobile phone or tablet. Receives: Device: augmented reality book |
| Group 2: Control Group | Experimental | In the preoperative period, the researcher will conduct a survey on the morning of the surgery day, approximately 1 hour before the surgery, using the "Child and Family Introductory Data Form", which includes the sociodemographic characteristics of the child and the accompanying parent. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. Data collection will take approximately 10 minutes in total. Immediately afterwards, the child will be asked by the researcher to read the story book "One Child, One Miracle". This group will be asked to just read the book without turning on the book's augmented reality feature. Afterwards, using the same scales, children will score the "CAS" scales, and the child, parent and researcher will score the "CFS" scales. Receives: Device: book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Information Form
A total of 23 questions are the researcher prepared the form in line with the literature.
The form is include two parts. One of theparts are include items questioning the child's diagnosis, length of hospital stay, sex, and whether he or she had been hospitalized or had surgery previously. The forms will filled by the researcherusing the face-to-face interview method.
Measured: in the preoperative period.
Secondary outcomes (2)
Determining the preoperative anxiety scores of children
This scale is a one-item self-report measure for measuring fear in level of children aged 5-12 years. Psychometric properties of Child fear scale in Turkish population were conducted by Gerçeker, Binay, et al. (2018). The Child fear scale is used by the child, parent, or researcher toassess children's fear levels. The Child fear scale can be administered to measure the level of fear experienced bychildren and anxiety levels of parents for their children before, during and after procedures. This self-report scale consists of a row offive faces ranging from a'no fear neutral face'on the far left to'a faceshowing extreme fear'on the far right. The face scored '0' indicates no fear, the face scored '1' indicates a little fear, the face scored '2' indicates some fear, the face scored '3' indicates more fear and the face scored '4' indicates extreme fear.
Measured: in the preoperative period.
Determining the preoperative fear scores of children
It assesses children's anxiety in clinical settings and uses before medical procedures. Psychometric properties of Children's anxiety meter ( in Turkish population were conducted by Gerçeker, Ayar, et al. (2018). The Children's anxiety meter (visual scale resembles a thermometer with alight bulb shape at the bottom and ten horizontal lines running from the bottom to the top. This scale is a self-report scale. A possible score that can be obtained from the Children's anxiety meter (can vary between '0' and '10'. To measure children's state anxiety levels, they are asked to mark how they feel' at the moment they are administered the Children's anxiety meter. We will measure the state anxiety levels of the children to determine their preoperative anxiety levels.
Measured: in the preoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start10 May 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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 Preoperative AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During the preoperative period, children who meet the inclusion criteria of the study will be determined from the list of children who will undergo surgery. Before the research, children who will undergo surgery and their parents will be informed on the morning of the surgery, approximately 1 hour before the surgery, and their written and verbal consent will be obtained. On the morning of the surgery day, the "Child and Family Introductory Data Form" will be filled out by children in the 7-12 age group and their parents who meet the inclusion criteria and agree to participate in the research. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. The application material to be used in the research is the story book titled 'One Child, One Miracle', which includes an augmented reality application.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Karaarslan, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399016
- Sponsor's protocol ID
- Augmented Reality Application
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sekeler A, Karaarslan D, Gulmez FB. Effects of reading augmented reality storybook versus normal storybook reading on preoperative fear and anxiety levels of children in the age group of 7-12 years: A randomized controlled trial. J Pediatr Urol. 2025 Oct;21(5):1295-1305. doi: 10.1016/j.jpurol.2025.02.025. Epub 2025 Feb 25.
PubMed 40074655
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reading a Book With Augmented Reality Application on the Level of Fear and Anxiety in Children in the 7-12 Age Group in the Preoperative Period
- ClinicalTrials.gov ID
- NCT06399016
- Acronym / sponsor ID
- Augmented Reality Application
- Conditions
- Preoperative Anxiety
- Keywords
- Child, fear, anxiety, operating theater tour, augmented reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 3 May 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.
Non-pharmacological methods such as multimedia applications and visual and auditory technological tools are used to create a more enjoyable experience by reducing children's fear and anxiety and distracting them in the preoperative period. With the latest developments in technology, live, immersive, augmented and virtual reality systems are seen to be included and used in preoperative preparation training, especially for pediatric patients. One of the applications of these innovative technologies that has attracted attention recently is augmented reality technology. The original value of this study is to reduce the fear and anxiety levels experienced by children reading books in the preoperative period with the application of augmented reality, which is a developing, promising and easily accessible technology. The method of this study consists of two groups: an augmented reality applied book reading group and a control group. In the preoperative period for both groups, a survey will be administered to the child and the accompanying parent using the "Child and Family Introductory Data Form", which includes sociodemographic characteristics, approximately 1 hour before the surgery. In addition, the child himself will be asked to score the "Child Anxiety Scale-State" scale to determine the level of anxiety about the surgery, and the child himself, the parent and the researcher will be asked to score the "Child Fear Scale" to determine the child's level of fear about the surgery. The book reading group with augmented reality application will be asked to read the voiced and animated book titled 'One Child, One Miracle', accompanied by an application downloaded free of charge from Google Play or IOS to their mobile phone or tablet. The storybook will be presented to the children in this application group in three dimensions with the help of a mobile phone or tablet. Children in the control group will read the same book without using the augmented reality application. After reading the book for both groups, the children will be asked to rate their fear and anxiety levels again using the same scales. This research is a randomized controlled and experimental study. The adequacy of the sample size in the study "G. It was calculated using the "Power-3.1.9.2" program. In the power analysis conducted for the sample and power calculation of the experimental study with the application and control groups, it was decided to study with 30 children for each group.
Detailed description
During hospitalization and exposure to medical procedures and surgical procedures, children perceive themselves as different from other children and experience feelings of inadequacy and feel hindered. Especially for school-age children aged 7-12, hospitalization means a process full of worries that cause anxiety and fear. In a study investigating the feelings of hospitalized children aged 7-12 about "hospital" and "disease", it was observed that children defined the hospital as a place where pain and painful procedures are performed most often, causing both themselves and their parents to be upset, and where they experience fear and anxiety. Because the hospital environment, staff, materials used and procedures to be performed are reflected as a state of uncertainty for every group of children hospitalized. This uncertainty they experience may affect the child's adaptation to the hospital and treatment, his communication with healthcare personnel, and his future hospital experience. Having an additional surgical intervention on the child in addition to hospitalization causes more stress and affects the child more both psychologically and physiologically. In a study, the psychosocial symptoms of 360 hospitalized children aged 6-12 were examined in terms of some variables. It has been determined that more than half of the children develop "anxiety" due to hospitalization, along with "regression", "communication difficulty", "hopelessness" and "anger" behaviors. In another study examining postoperative behavioral changes in Chinese children who underwent hypospadias surgery, it was determined that three-fifths of the children showed behavioral changes that lasted for several weeks after surgery.
The success of surgery in children is not only related to the importance of the techniques and skills applied, but also to the preparation of the child and the parent and meeting the care needs in the preoperative period. Preparing the child patient appropriately in the preoperative period prevents him from experiencing both behavioral and physiological symptoms of fear and anxiety. Studies have shown that more than 60% of children who undergo surgery experience anxiety before surgery and anesthesia. However, in children who were psychologically affected in the preoperative period, maladaptive behavioral changes such as anxiety, eating and sleeping disorders, nightmares, enuresis and tantrums occurred in the postoperative period. Some intervention practices have been developed to reduce preoperative fear and anxiety in children and to prevent anxiety-related behavioral changes. These practices include various behavioral preparation programs used to distract from nonpharmacological practices. Such approaches help children to divert their attention from fearful and painful procedures by keeping them active. In methods of diverting attention; Methods such as daydreaming, listening to music, hypnosis, relaxation techniques, breathing control, biofeedback exercises, watching videos, reading books, telling stories and games are used. In a study, it was observed that children aged 4-10 years of age reduced their stress, their parents' anxiety, and postoperative delirium by providing distraction via tablets and phones in the preoperative period, and increased cooperation with medical personnel during anesthesia induction. The preparations to be made according to the child's age, period characteristics and understanding capacity should be explained to the child so that he/she does not feel afraid. Because preoperative anxiety is associated with an increased incidence of delirium, pain, and postoperative maladaptive behavior in the child. It can also manifest itself in various ways such as agitation, crying, shaking, struggle and escape behaviors. Therefore, the main goal in preparing for the surgery process is to maintain the child-parent relationship, reduce fears and anxiety arising from the unknown, and psychologically support the child and parents. Preoperative interventions have been increasingly used in hospital settings over the past few years. It has been observed that fear and anxiety arising from the preoperative period in children, video glasses, video displaying smartphones and tablets reduce postoperative delirium.
Hypothesis of the Research:
Hypothesis 1. H1: Reading books with augmented reality application in the preoperative period reduces the level of fear in children aged 7-12.
Hypothesis 2. H1: Reading books with augmented reality application in the preoperative period reduces the anxiety level in children aged 7-12.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- During the preoperative period, children who meet the inclusion criteria of the study will be determined from the list of children who will undergo surgery. Before the research, children who will undergo surgery and their parents will be informed on the morning of the surgery, approximately 1 hour before the surgery, and their written and verbal consent will be obtained. On the morning of the surgery day, the "Child and Family Introductory Data Form" will be filled out by children in the 7-12 age group and their parents who meet the inclusion criteria and agree to participate in the research. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. The application material to be used in the research is the story book titled 'One Child, One Miracle', which includes an augmented reality application.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Augmented Reality Applied Book Reading Group | Experimental | Device: augmented reality bookChildren included in this group will be asked to read books supported by augmented reality technology. Approximately 1 hour before the surgery, a survey will be administered to the child and the accompanying parent using the "Child and Family Introductory Data Form", which includes sociodemographic characteristics. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. Data collection will take approximately 10 minutes in total. Immediately afterwards, the researcher will ask the child to read the book 'One Child, One Miracle', which is a technology-supported augmented reality application, with the help of an application previously downloaded free of charge from Google Play or IOS to a mobile phone or tablet. |
| Group 2: Control Group | Experimental | Device: bookIn the preoperative period, the researcher will conduct a survey on the morning of the surgery day, approximately 1 hour before the surgery, using the "Child and Family Introductory Data Form", which includes the sociodemographic characteristics of the child and the accompanying parent. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score. Data collection will take approximately 10 minutes in total. Immediately afterwards, the child will be asked by the researcher to read the story book "One Child, One Miracle". This group will be asked to just read the book without turning on the book's augmented reality feature. Afterwards, using the same scales, children will score the "CAS" scales, and the child, parent and researcher will score the "CFS" scales. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Between the ages of 7-12
- Children who will undergo surgery for the first time will be included
- No communication problems (vision, hearing, mental),
- Both his/her parents volunteer to participate in the research, and their parents give written and verbal consent,
Key exclusion criteria (3 listed)
- Children have genetic or congenital disease,
- Children have a chronic disease
- Children have previous surgery
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 |
|---|---|---|
| augmented reality bookAlso: Augmented reality applied book titled 'One Child, One Miracle'The story will be presented to the children in this application group in three dimensions. The augmented reality application will be supported by the researcher as it must be used under the supervision of an adult. When the tablet or phone is held to the pages of the book, the animations of these pages are displayed on the screen with sound. While the animation opens automatically when we hold the phone or tablet, the story can be listened to aloud at the same time. | Device | Group 1: Augmented Reality Applied Book Reading Group |
| bookAlso: 'One Child, One Miracle'This group will be asked to just read the book without turning on the augmented reality feature of the book. | Device | Group 2: Control Group |
Primary outcome
Sociodemographic Information Form
Time frame: in the preoperative period.
A total of 23 questions are the researcher prepared the form in line with the literature. The form is include two parts. One of theparts are include items questioning the child's diagnosis, length of hospital stay, sex, and whether he or she had been hospitalized or had surgery previously. The forms will filled by the researcherusing the face-to-face interview method.
2 secondary outcomes
Determining the preoperative anxiety scores of children
Time frame: in the preoperative period.
Determining the preoperative fear scores of children
Time frame: in the preoperative period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 40074655Sekeler A, Karaarslan D, Gulmez FB. Effects of reading augmented reality storybook versus normal storybook reading on preoperative fear and anxiety levels of children in the age group of 7-12 years: A randomized controlled trial. J Pediatr Urol. 2025 Oct;21(5):1295-1305. doi: 10.1016/j.jpurol.2025.02.025. Epub 2025 Feb 25.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing augmented reality book and book in people with Preoperative Anxiety, run by Manisa Celal Bayar University at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Karaarslan (05062146960, duygukrrsln@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Information Form (time frame: in the preoperative period.). 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 NCT06399016, 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 3 May 2024.