Reducing the Anxiety of Children and Their Parents in the Preoperative Process

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279976
• Other study ID #: AkdUniversity
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: January 20, 2025

Study information

• Verified date: January 2024
• Source: Akdeniz University
• Contact: Ayla Kaya, RN, PhD
• Phone: +902423106103
• Email: aylakaya[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child
• Parent
• Preoperative Care

Intervention

Other:
• Visualized Education
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.
• Distraction
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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya	Konyaalti

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	Isparta University of Applied Sciences

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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

Outcome

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.