Pediatric ALLNCT04960761
The Effectiveness of the Training Given With Audio and Picture Book Before the Surgery
A study testing İntervention Group in people with Pediatric ALL and Appendix Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Appendix Diseases
- What is being tested?
- İntervention Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Being literate
- The child's mother or father
- Parent can use smartphone
Who cannot join
- Parent/child not accepting the research
- Presence of a parent/child's mental disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri University
Istanbul, Istanbul
About this study
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
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.
- Conditions
- Pediatric ALL, Appendix Diseases
- Being tested
- İntervention Group
- Keywords
- anxiety, surgery, child, mobilization, quality of life
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention GroupOther
Also called Control 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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.). Receives: Other: İntervention Group |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative period(one hour before surgery) and one day after surgery
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.
Measured: Preoperative period(one hour before surgery) and one day after surgery
Secondary outcomes (2)
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.
Measured: Preoperative period(one hour before surgery) and one day after surgery
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.
Measured: About 4-6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start31 Aug 2021 (estimated)
- Primary completion31 May 2022
- Study completion31 Dec 2022
Why it stopped: The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci Akpinar, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960761
- Sponsor's protocol ID
- 2021-21/15
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18361093Nilsson 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 27712311Kain 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 9842807Coskunturk 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 29398304Hatava 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 11012950Li 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04960761
- Acronym / sponsor ID
- 2021-21/15
- Conditions
- Pediatric ALL, Appendix Diseases
- Keywords
- anxiety, surgery, child, mobilization, quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: İntervention GroupPre-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.). |
| Control Group | No intervention | –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 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child criteria
- Parent criteria
Key exclusion criteria (2 listed)
- Parent/child not accepting the research
- Presence of a parent/child's mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| İntervention GroupAlso: Control GroupIn 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 | Intervention Group |
Primary outcome
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
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.
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
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.
2 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 18361093Ono 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.
- Background: PubMed 27712311Nilsson 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.
- Background: PubMed 9842807Kain 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.
- Background: PubMed 29398304Coskunturk 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.
- Background: PubMed 11012950Hatava 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.
- Background: PubMed 18366374Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntervention Group in people with Pediatric ALL and Appendix Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960761, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.