Preoperative CareNCT05279976
Reducing the Anxiety of Children and Their Parents in the Preoperative Process
A study testing Visualized Education and Distraction in people with Preoperative Care and Child, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is to inform the child and family with preoperative family-centered activities. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Care, Child, Parent
- What is being tested?
- Visualized Education and Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 26 Sep 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child between the ages of 5-12 for which a surgical operation is planned
- Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
- Not having vision, hearing or speech problems
- Not have a mental or neurological disability
- Children and parents who can speak and understand Turkish will be included in the study.
Who cannot join
- Change in surgical operation date
- Using another distraction technique
- Children who do not arrive on the day of surgery will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Visualized Education and Distraction in the Preoperative Process on Reducing the Anxiety of Children and Their Parents: a Randomized Controlled Study
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is to inform the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents' anxiety on the day of surgery in the preoperative period.
Read the detailed description
Aim: This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents' anxiety on the day of surgery in the preoperative period.
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; Education group=35, distraction group=35, and control group=35 children, a total of 105 children in 3 groups and their parents were planned to be included in the study. Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: The study was planned to be implemented in the Akdeniz University Hospital Operating Room Patient Preparation Room, after the approval of the Akdeniz University Ethics Committee and the written permission of the Akdeniz University Hospital. It will be ensured that the child and parent are together during the initiatives. No intervention will be applied to the parents included in the sample of the study. After explaining the purpose of the study to the child and parent who agreed to participate in the study and obtaining consent, randomization will be performed. The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test (first measurement). Children included in this group will be provided to touch the bonnet, mask, gloves and self-inflated balloon (representing the ambu device), and the questions of the child and the parent will be answered. Children and parents included in this group will form intervention group 1 (35 children, 35 parents).
The child, who was assigned to intervention group 2 as a result of randomization, will be provided with the use of kaleidoscope, which is a distraction technique, immediately after the pre-test (first measurement). The second measurement will be made immediately after the child wears the surgical gown. Children and parents included in this group will form intervention group 2 (35 children, 35 parents).
Children randomized to the control group will not receive any intervention. A pre-test (first measurement) will be made for the child who is assigned to the control group as a result of randomization, and the second measurement will be made immediately after the child wears the surgical gown. Children and parents included in this group will form control group (35 children, 35 parents).
After all post-test (second measurement) applications are completed, the effectiveness of the interventions and their comparison with each other will be evaluated. After the post-test application of the research is completed, the data obtained will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
- Conditions
- Preoperative Care, Child, Parent, Anxiety
- Being tested
- Visualized Education, Distraction
- Keywords
- Preoperative care, Child, Parents, Nursing, Randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualized EducationOther
The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test (first measurement). Children included in this group will be provided to touch the bonnet, mask, gloves and self-inflated balloon (representing the ambu device), and the questions of the child and the parent will be answered.
DistractionOther
Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child.
| Study group | Role | What they receive |
|---|---|---|
| Children receiving education-Intervention group 1 (35 children) | Experimental | Children in the intervention group 1 will be told by the researchers the operation preparation room and the pre-anesthesia process with a picture booklet. It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed. Simultaneous visual presentation will be made with the content of the picture booklet being explained to the child. While one of the researchers will explain the pre-operative process from the picture booklet, the other will explain the pre-operative preparation process simultaneously with the picture booklet by putting on the bonnet, mask and glove, and with the balloon inflated by the child. In this way, the pictures shown in the picture booklet will be matched with the real environment. Receives: Other: Visualized Education |
| Children who are distracted-Intervention group 2 (35 children) | Experimental | Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child.
Usage of Kaleidoscope: It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. Inside the kaleidoscope, there are mirrors or glasses placed with an inclination of 60 degrees. When viewed from one side of the kaleidoscope, images are often seen that are not the same. Receives: Other: Distraction |
| Control group of children (35 children) | No intervention | After obtaining informed consent from the children and parents included in the control group after randomization, the pre-test (first measurement) will be applied. The final test (Second Measurement) will be applied immediately after the child wears the surgical gown. |
| Parents of children receiving education-Intervention group 1 (35 parents) | Experimental | The parents of children included in intervention group 1 will also be in intervention group 1.It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed. Receives: Other: Visualized Education |
| Parents of distracted children-Intervention group 2 (35 parents) | Experimental | The parents of children included in intervention group 2 will also be in intervention group 2. Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. Receives: Other: Distraction |
| Control group of parents (35 parents) | No intervention | The parents of children included in control group will also be in control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children receiving education-Intervention group 1
The decrease in anxiety level of children in this group who received visualized education is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the visualized education has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Measured: Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
Children who are distracted-Intervention group 2
The decrease in anxiety level of children in this group who are distracted by the keladoscope is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the distracted by the keladoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Measured: Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
Parents of children receiving education-Intervention group 1
The decrease in anxiety level of parents in this group who parents of children receiving education is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the education has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Measured: Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
Parents of distracted children-Intervention group 2
The decrease in anxiety level of parents in this group who parents of distracted children is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distracted by the kaleidoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Measured: Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start6 Jun 2023
- Primary completion6 Jun 2023
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preoperative CareStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Isparta University of Applied Sciences
- Responsible party
- Principal investigator, Ayla Kaya, Akdeniz University
- Investigators
- Ayla Kaya, RN, PhD, Study director, Akdeniz University Faculty of NursingFahriye Pazarcıkcı, RN, PhD, Study chair, Isparta University of Applied SciencesEmine Efe, RN, PhD, Study chair, Akdeniz University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279976
- Sponsor's protocol ID
- AkdUniversity
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aytekin A, Doru O, Kucukoglu S. The Effects of Distraction on Preoperative Anxiety Level in Children. J Perianesth Nurs. 2016 Feb;31(1):56-62. doi: 10.1016/j.jopan.2014.11.016. Epub 2015 Nov 11.
PubMed 26847781Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.
PubMed 31391620Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
PubMed 32703758Dwairej DA, Obeidat HM, Aloweidi AS. Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial. J Spec Pediatr Nurs. 2020 Jan;25(1):e12272. doi: 10.1111/jspn.12272. Epub 2019 Oct 1.
PubMed 31576651Pazarcikci F, Efe E. Effect of care programme based on Comfort Theory on reducing parental anxiety in the paediatric day surgery: Randomised controlled trial. J Clin Nurs. 2022 Apr;31(7-8):922-934. doi: 10.1111/jocn.15945. Epub 2021 Jul 8.
PubMed 34240490Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
PubMed 30413359Kaya A, Pazarcikci F, Efe E. Visual Education and Distraction for Reducing Preoperative Anxiety in Children and Parents: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Jun;32(3):e70158. doi: 10.1111/ijn.70158.
PubMed 42208603
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visualized Education and Distraction in the Preoperative Process on Reducing the Anxiety of Children and Their Parents: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05279976
- Acronym / sponsor ID
- AkdUniversity
- Conditions
- Preoperative Care, Child, Parent, Anxiety
- Keywords
- Preoperative care, Child, Parents, Nursing, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Isparta University of Applied Sciences
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 15 Mar 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.
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is to inform the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents' anxiety on the day of surgery in the preoperative period.
Detailed description
Aim: This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents' anxiety on the day of surgery in the preoperative period.
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; Education group=35, distraction group=35, and control group=35 children, a total of 105 children in 3 groups and their parents were planned to be included in the study. Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: The study was planned to be implemented in the Akdeniz University Hospital Operating Room Patient Preparation Room, after the approval of the Akdeniz University Ethics Committee and the written permission of the Akdeniz University Hospital. It will be ensured that the child and parent are together during the initiatives. No intervention will be applied to the parents included in the sample of the study. After explaining the purpose of the study to the child and parent who agreed to participate in the study and obtaining consent, randomization will be performed. The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test (first measurement). Children included in this group will be provided to touch the bonnet, mask, gloves and self-inflated balloon (representing the ambu device), and the questions of the child and the parent will be answered. Children and parents included in this group will form intervention group 1 (35 children, 35 parents).
The child, who was assigned to intervention group 2 as a result of randomization, will be provided with the use of kaleidoscope, which is a distraction technique, immediately after the pre-test (first measurement). The second measurement will be made immediately after the child wears the surgical gown. Children and parents included in this group will form intervention group 2 (35 children, 35 parents).
Children randomized to the control group will not receive any intervention. A pre-test (first measurement) will be made for the child who is assigned to the control group as a result of randomization, and the second measurement will be made immediately after the child wears the surgical gown. Children and parents included in this group will form control group (35 children, 35 parents).
After all post-test (second measurement) applications are completed, the effectiveness of the interventions and their comparison with each other will be evaluated. After the post-test application of the research is completed, the data obtained will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children receiving education-Intervention group 1 (35 children) | Experimental | Other: Visualized EducationChildren in the intervention group 1 will be told by the researchers the operation preparation room and the pre-anesthesia process with a picture booklet. It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed. Simultaneous visual presentation will be made with the content of the picture booklet being explained to the child. While one of the researchers will explain the pre-operative process from the picture booklet, the other will explain the pre-operative preparation process simultaneously with the picture booklet by putting on the bonnet, mask and glove, and with the balloon inflated by the child. In this way, the pictures shown in the picture booklet will be matched with the real environment. |
| Children who are distracted-Intervention group 2 (35 children) | Experimental | Other: DistractionChildren included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child. Usage of Kaleidoscope: It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. Inside the kaleidoscope, there are mirrors or glasses placed with an inclination of 60 degrees. When viewed from one side of the kaleidoscope, images are often seen that are not the same. |
| Control group of children (35 children) | No intervention | –After obtaining informed consent from the children and parents included in the control group after randomization, the pre-test (first measurement) will be applied. The final test (Second Measurement) will be applied immediately after the child wears the surgical gown. |
| Parents of children receiving education-Intervention group 1 (35 parents) | Experimental | Other: Visualized EducationThe parents of children included in intervention group 1 will also be in intervention group 1.It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed. |
| Parents of distracted children-Intervention group 2 (35 parents) | Experimental | Other: DistractionThe parents of children included in intervention group 2 will also be in intervention group 2. Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. |
| Control group of parents (35 parents) | No intervention | –The parents of children included in control group will also be in control group. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being a child between the ages of 5-12 for which a surgical operation is planned
- Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
- Not having vision, hearing or speech problems
- Not have a mental or neurological disability
- Children and parents who can speak and understand Turkish will be included in the study.
Key exclusion criteria (3 listed)
- Change in surgical operation date
- Using another distraction technique
- Children who do not arrive on the day of surgery will not be included in the study.
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 |
|---|---|---|
| Visualized EducationThe child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test (first measurement). Children included in this group will be provided to touch the bonnet, mask, gloves and self-inflated balloon (representing the ambu device), and the questions of the child and the parent will be answered. | Other | Children receiving education-Intervention group 1 (35 children), Parents of children receiving education-Intervention group 1 (35 parents) |
| DistractionChildren included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child. | Other | Children who are distracted-Intervention group 2 (35 children), Parents of distracted children-Intervention group 2 (35 parents) |
Primary outcome
Children receiving education-Intervention group 1
Time frame: Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
The decrease in anxiety level of children in this group who received visualized education is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the visualized education has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Children who are distracted-Intervention group 2
Time frame: Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
The decrease in anxiety level of children in this group who are distracted by the keladoscope is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the distracted by the keladoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Parents of children receiving education-Intervention group 1
Time frame: Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
The decrease in anxiety level of parents in this group who parents of children receiving education is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the education has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
Parents of distracted children-Intervention group 2
Time frame: Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.
The decrease in anxiety level of parents in this group who parents of distracted children is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distracted by the kaleidoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p < 0.05.
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 1 Oct 2024.
- Background: PubMed 26847781Aytekin A, Doru O, Kucukoglu S. The Effects of Distraction on Preoperative Anxiety Level in Children. J Perianesth Nurs. 2016 Feb;31(1):56-62. doi: 10.1016/j.jopan.2014.11.016. Epub 2015 Nov 11.
- Background: PubMed 31391620Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.
- Background: PubMed 32703758Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
- Background: PubMed 31576651Dwairej DA, Obeidat HM, Aloweidi AS. Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial. J Spec Pediatr Nurs. 2020 Jan;25(1):e12272. doi: 10.1111/jspn.12272. Epub 2019 Oct 1.
- Background: PubMed 34240490Pazarcikci F, Efe E. Effect of care programme based on Comfort Theory on reducing parental anxiety in the paediatric day surgery: Randomised controlled trial. J Clin Nurs. 2022 Apr;31(7-8):922-934. doi: 10.1111/jocn.15945. Epub 2021 Jul 8.
- Background: PubMed 30413359Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
- Derived from this study: PubMed 42208603Kaya A, Pazarcikci F, Efe E. Visual Education and Distraction for Reducing Preoperative Anxiety in Children and Parents: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Jun;32(3):e70158. doi: 10.1111/ijn.70158.
- 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.
Ayla Kaya, RN, PhD study director
Akdeniz University Faculty of Nursing
Fahriye Pazarcıkcı, RN, PhD study chair
Isparta University of Applied Sciences
Emine Efe, RN, PhD study chair
Akdeniz University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualized Education and Distraction in people with Preoperative Care and Child, run by Akdeniz 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 5 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: finished, as of the sponsor's last update on 1 Oct 2024. 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?
Children receiving education-Intervention group 1 (time frame: Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.). The study lists 4 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 NCT05279976, which also lists 7 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 1 Oct 2024.