Clinical trial NCT04960761: The Effectiveness of the Training Given With Audio and Picture Book Before the Surgery
Official title: The Effect of Education Given to Children With Audio and Picture Books on Anxiety, Quality of Life and Early Mobilization in the Preoperative Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric ALL
Appendix Diseases
Keywords: anxiety
surgery
child
mobilization
quality of life
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Behavioral practices applied to the child in the preoperative period; It includes methods such as introducing the hospital and operating room to children and their parents, reading storybooks, giving training books, an educational internet application with interactive games, and using visual aids. At the same time, by using an appropriate anatomy book, it can help the child to visualize his body correctly, to understand the size and location of the surgical site, and to learn where the suture will be after the intervention.In this study, it was aimed to evaluate the effect of preoperative education with the help of audio and picture books on postoperative anxiety, quality of life and early mobilization.

Detailed description: Psychological preparation process in the pre-operative period; It reduces anxiety, uses less anesthetic during the operation, normalizes vital signs in a short time, uses less painkillers and helps early discharge. Behavioral practices applied to the child in the preoperative period; It includes methods such as introducing the hospital and operating room to children and their parents, reading storybooks, giving training booklets, an educational internet application with interactive games, and using visual aids. At the same time, by using an appropriate anatomy book, it can help the child to visualize his body correctly, to understand the size and location of the surgical site, and to learn where the suture will be after the intervention. No study was found in which children aged 8-12 years were educated with the help of audio and picture books before appendectomy and evaluated postoperative anxiety, quality of life and mobilization time. In this study, it was aimed to evaluate the effect of preoperative education with the help of audio and picture books on postoperative anxiety, quality of life and early mobilization. The study was planned randomized controlled study. The statistical universe of this study, includes pediatric patients who operated between February 2021 and December 2021 in Pediatric Surgery Department in Zeynep Kamil Maternity and Children's hospital. The sample includes who operated with appendectomy between the ages of 8 and 12 who met the inclusion criteria in the Pediatric Surgery Clinic as 60 children. Participants will be divided into two equal groups as intervention (n=30) and control (n=30) groups. Children and Parents Descriptive Characteristics Form, State Anxiety Inventory for Children, State Anxiety Inventory (for Parents), Quality of Life Scale for Children, Evaluation of Postoperative Mobilization Time will be used to collect data. Data will be analyzed with appropriate statistical methods using the SPSS for Windows 22.0 program (Statistical Package for the Social Sciences). Descriptive statistical methods such as percentile, mean, standard deviation and median in the evaluation of data and Kolmogorov-Smirnov distribution test for examining normal distribution, chi-square test, t-test/Mann Whitney-U test for measurement data, One-Way ANOVA/Kruskall Wallis tests will be used.

Eligibility criteria: Inclusion Criteria:

* Child criteria

  * Be between 8-12 years old
  * Having an appendectomy operation
  * ASA classification I and II
  * Staying in hospital for at least 24 hours after surgery
* Parent criteria

  * Being literate
  * The child's mother or father
  * Parent can use smartphone

Exclusion Criteria:

* Parent/child not accepting the research
* Presence of a parent/child's mental disability

Primary outcomes:
measure: Determining the change in children's anxiety levels with the state anxiety inventory for children
timeFrame: Preoperative period(one hour before surgery) and one day after surgery
measure: Determination of the change in parents' anxiety levels with the state anxiety inventory for parents
timeFrame: Preoperative period(one hour before surgery) and one day after surgery
Secondary outcomes:
measure: Determination of the change in quality of life levels of children with the quality of life scale for children
timeFrame: Preoperative period(one hour before surgery) and one day after surgery
measure: Determination of the change in the mobilization time of children after the surgery with the mobilization time form for children
timeFrame: About 4-6 hours after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri University
Study officials:
References:
citation: Ono S, Oikawa I, Hirabayashi Y, Manabe Y. Preparation of a picture book to support parents and autonomy in preschool children facing day surgery. Pediatr Nurs. 2008 Jan-Feb;34(1):82-3, 88. No abstract available.
citation: Nilsson E, Svensson G, Frisman GH. Picture book support for preparing children ahead of and during day surgery. Nurs Child Young People. 2016 Oct 7;28(8):30-35. doi: 10.7748/ncyp.2016.e749.
citation: Kain ZN, Caramico LA, Mayes LC, Genevro JL, Bornstein MH, Hofstadter MB. Preoperative preparation programs in children: a comparative examination. Anesth Analg. 1998 Dec;87(6):1249-55. doi: 10.1097/00000539-199812000-00007.
citation: Coskunturk AE, Gozen D. The Effect of Interactive Therapeutic Play Education Program on Anxiety Levels of Children Undergoing Cardiac Surgery and Their Mothers. J Perianesth Nurs. 2018 Dec;33(6):781-789. doi: 10.1016/j.jopan.2017.07.009. Epub 2018 Feb 3.
citation: Hatava P, Olsson GL, Lagerkranser M. Preoperative psychological preparation for children undergoing ENT operations: a comparison of two methods. Paediatr Anaesth. 2000;10(5):477-86. doi: 10.1046/j.1460-9592.2000.00537.x.
citation: Li HC, Lopez V. Effectiveness and appropriateness of therapeutic play intervention in preparing children for surgery: a randomized controlled trial study. J Spec Pediatr Nurs. 2008 Apr;13(2):63-73. doi: 10.1111/j.1744-6155.2008.00138.x.