Anxiety Clinical Trial
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | January 20, 2025 |
Est. primary completion date | September 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University | Antalya | Konyaalti |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University | Isparta University of Applied Sciences |
Turkey,
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. — View Citation
Baghele 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. — View Citation
Bulut 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. — View Citation
Dwairej 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. — View Citation
Pazarcikci 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. — View Citation
Stewart 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | |
Primary | 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. | 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. | |
Primary | 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. | 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. | |
Primary | 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. | 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. |
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