- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04960761
The Effectiveness of the Training Given With Audio and Picture Book Before the Surgery
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zümray Özbek
- Phone Number: +905534405190
- Email: aybekzumray@gmail.com
Study Contact Backup
- Name: Elif Gezginci, RN, PhD
- Phone Number: +905320656343
- Email: elif.gezginci@sbu.edu.tr
Study Locations
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-
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Istanbul, Turkey
- Sağlık Bilimleri University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.).
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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.
Other Names:
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determining the change in children's anxiety levels with the state anxiety inventory for children
Time Frame: Preoperative period(one hour before surgery) and one day after surgery
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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.
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Preoperative period(one hour before surgery) and one day after surgery
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Determination of the change in parents' anxiety levels with the state anxiety inventory for parents
Time Frame: Preoperative period(one hour before surgery) and one day after surgery
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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.
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Preoperative period(one hour before surgery) and one day after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of the change in quality of life levels of children with the quality of life scale for children
Time Frame: Preoperative period(one hour before surgery) and one day after surgery
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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.
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Preoperative period(one hour before surgery) and one day after surgery
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Determination of the change in the mobilization time of children after the surgery with the mobilization time form for children
Time Frame: About 4-6 hours after surgery
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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.
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About 4-6 hours after surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-21/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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