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WithdrawnNCT04960761Updated Oct 2, 2026

The Effectiveness of the Training Given With Audio and Picture Book Before the Surgery

An interventional study of İntervention Group in Pediatric ALL and Appendix Diseases, sponsored by Saglik Bilimleri Universitesi. Withdrawn at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Other

Why this study was withdrawn
The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
Updated Oct 2, 2026Now WithdrawnFirst site in Turkey (Türkiye)+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric ALL
  • Appendix Diseases

Keywords

  • anxiety
  • surgery
  • child
  • mobilization
  • quality of life
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Parent/child not accepting the research
  • Presence of a parent/child's mental disability
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Pre-operative training will be given by the clinic nurse with audio and picture book. Training content with audio and picture book; Before the operation, the procedures performed during the admission of the patient to the service (introducing the clinic and staff to the patient), what are the preoperative preparations (checking vital signs, intravenous (IV) catheter application, wearing a surgical gown), wearing a patient tag on the wrist, taking him to the operating room on a stretcher), which will be used during the operation anesthesia techniques and how to provide sedation (the anesthetic agent can be given by mask or IV catheter, the reasons are the clothes worn by doctors and nurses in the operating room), what are the procedures that can be applied after the surgery (vital signs control, monitoring, oxygen administration, serum insertion, etc.).

    Other: İntervention Group

  • No intervention
    Control Group

    Routine training will be given by a nurse working in the clinic during the preoperative period. The content of the routine training: What are the procedures performed during the admission of the patient to the service before the operation (introducing the clinic and the staff to the patient), what the preoperative preparation is (checking vital signs, intravenous (IV) catheter application, wearing a surgical gown, wearing a patient tag on the wrist, with a stretcher. being taken to the operating room), what are the procedures that can be applied after the surgery (vital signs control, monitoring, oxygen administration, serum insertion, etc.), there may be some medical materials that were applied to the patient during the surgery (nasogastric tube, IV catheter, types of drains placed in the wound site) includes information such as

Interventions

  • Otherİntervention Group

    In the experimental group, pre-operative anxiety and quality of life scales will be applied to the child and their parents before and after the operation with audio and picture books, the preoperative quality of life scale will be made, the postoperative anxiety and quality of life scale will be repeated and the early mobilization scale will be made. The control group will be routinely informed before the operation, an anxiety scale will be given to the child and their parents before the operation, a quality of life scale will be given to the child, the postoperative anxiety and quality of life scale will be repeated, and early mobilization form will be applied.

    Also known as: Control Group

06

What researchers measure

Primary outcomes

  1. Determining the change in children's anxiety levels with the state anxiety inventory for children

    The measure of this study is to determine the effect of informing with audio and picture books on children's anxiety in the preoperative period with the state anxiety inventory for children.

    Time frame: Preoperative period(one hour before surgery) and one day after surgery

  2. Determination of the change in parents' anxiety levels with the state anxiety inventory for parents

    The measure of this study is to determine the effect of parental state anxiety inventory and preoperative information with audio and picture books on parents' anxiety.

    Time frame: Preoperative period(one hour before surgery) and one day after surgery

Secondary outcomes

  1. Determination of the change in quality of life levels of children with the quality of life scale for children

    The measure of this study is to determine the change in quality life of children, who are informed with audio and picture books before surgery, and the effectiveness with the quality of life scale for children.

    Time frame: Preoperative period(one hour before surgery) and one day after surgery

  2. Determination of the change in the mobilization time of children after the surgery with the mobilization time form for children

    The measure of this study is to determine the change in mobilization time of children, who are informed with audio and picture books before surgery, with the mobilization form.

    Time frame: About 4-6 hours after surgery

07

Study locations

1 site
  • Sağlık Bilimleri University
    Istanbul, Istanbul, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 18361093 ↗
  • 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. PubMed 27712311 ↗
  • 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. PubMed 9842807 ↗
  • 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. PubMed 29398304 ↗
  • 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. PubMed 11012950 ↗
  • 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. PubMed 18366374 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Withdrawn The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
changed Oct 2, 2026
Sites
1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
Show site
  • Sağlık Bilimleri University · Istanbul, Turkey (Türkiye)
Show 1 removed
  • Sağlık Bilimleri University · Istanbul, Turkey
Oct 2, 2026
Enrollment
70 (estimated)→0 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Status unknown→Withdrawn
    Why stopped The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
    1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
    Show site
    • Sağlık Bilimleri University · Istanbul, Turkey (Türkiye)
    Show 1 removed
    • Sağlık Bilimleri University · Istanbul, Turkey
    Enrollment 70 (estimated)→0 (actual)
    + 5 other changes: index terms, verification date, date precision, responsible party and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04960761
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Elif Gezginci Akpinar (RN, PhD, Asst Prof. Surgical Nursing, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Jul 14, 2021
Start date
Aug 31, 2021 (estimated)
Primary completion
May 31, 2022
Completion
Dec 31, 2022
Last update
Oct 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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