Effect of Short Film Video Training Prepared for Children Undergoing Bone Marrow Aspiration and Biopsy

January 6, 2026 updated by: Atiye Karakul, Tarsus University

Effect of Short Film Video Training Prepared for Children Undergoing Bone Marrow Aspiration and Biopsy on Children's Anxiety, Fear, Pain and Satisfaction

In this study, it is aimed to examine the effect of short film video education given to children aged 7-12 years who will undergo CIAB before the procedure on the anxiety, fear, pain and satisfaction levels of the children. It will be carried out in a single-center, randomized controlled experimental design. The universe of the study will be children aged 7-12 who applied to the Children's Department of Mersin University Oncology and Hematology Hospital, and the sample will consist of 60 children who meet the criteria for inclusion in the study. In the collection of research data; Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Numerical Pain Scale, Vital Signs Follow-up Form and Child Satisfaction Scale will be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to examine the effects of short film video training given to children aged 7-12 years who will undergo CIAB before the procedure on the anxiety, fear, pain and satisfaction levels of the children. It will be carried out in a single-center, randomized controlled experimental design. The universe of the study will be children aged 7-12 who applied to the Children's Department of Mersin University Oncology and Hematology Hospital, and the sample will consist of 60 children who meet the criteria for inclusion in the study.

Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Numerical Pain Scale, Vital Sign Follow-up Form and Child Satisfaction Scale will be used in the collection of research data.

Data Collection

  • Data will be collected in the waiting room after the child is examined in the clinic. In the collection of data, the child patients and their parents who meet the inclusion criteria of the study and agree to participate in the study, will be informed about the purpose of the study and the research, and their verbal and written permissions will be obtained.
  • Patients who meet the sample selection criteria will be randomly and equally distributed into 2 groups (1st experimental group, 2nd control group) via a computer program (http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html).
  • The data collection forms in the study (Introductory Information Form, Child Anxiety Scale, Child Fear Scale and Vital Signs Follow-up Form) will be applied to the children and parents in the sample group. The anxiety and fear assessment of the children will be carried out by the child, nurse and parent.
  • A short film video training will be introduced to the children and parents in the experimental group and the children will be allowed to watch it on a tablet. After watching the short film video training, the children will be applied the CIAB procedure.
  • The routine application of the clinic (verbal information) will be applied to the children and parents in the control group.
  • After the CIAB procedure, the Child Anxiety Scale, Child Fear Scale, Numerical Pain Scale, Vital Signs Follow-up Form and Child Satisfaction Scale will be applied to all groups in the experimental and control groups. The anxiety, fear and pain assessment of the children will be carried out by the child, nurse and parent.

Statistical package program (SPSS 20) will be used in the analysis of the research data. The statistical significance level was determined as 0.05. The conformity of the data used to the normal distribution will be checked with kurtosis and skewness values. In the comparison of quantitative data with normal distribution, independent t test will be applied for the difference between two independent groups, and in the comparison of more than two dependent groups, variance analysis in repeated measurements will be applied, and in the case of a difference, Bonferroni will be used to find the group that made the difference. In the comparison of quantitative data with non-normal distribution, Mann Whitney U test will be applied for the difference between two independent groups, and in the comparison of more than two dependent groups, Friedman test will be applied, and in the case of a difference, corrected Bonferroni will be used to find the group that made the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in the inter-observer agreement analysis. In addition, at the end of the research, the status of working with a sufficient sample size will be tested with post-hoc power analysis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 7-12
  • The child will undergo bone marrow aspiration and biopsy
  • The child will undergo bone marrow aspiration and biopsy for the first time
  • Volunteering to participate in the study

Exclusion Criteria:

  • Not being between the ages of 7-12
  • Having another chronic disease
  • Having a family member undergo bone marrow aspiration and biopsy
  • Having a communication, mental or neurological problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short Film Video
The short film training video will be prepared by researchers based on literature and appropriate for the level of children aged 7-12. The content will include topics such as preparation for KİAB, KİAB environment and the process after KİAB. Since the short film will be shot in a realistic manner, the scenario will include a doctor, a nurse, a child patient and a parent. The short film will be shot in the clinic where the data will be collected, at the appropriate time for the clinic. After the short film is shot, the editing process will be done and the final version will be given.
Other: Short film video
The short film training video will be prepared by researchers based on literature and appropriate for the level of children aged 7-12. The content will include topics such as preparation for KİAB, KİAB environment and the process after KİAB. Since the short film will be shot in a realistic manner, the scenario will include a doctor, a nurse, a child patient and a parent. The short film will be shot in the clinic where the data will be collected, at the appropriate time for the clinic. After the short film is shot, the editing process will be done and the final version will be given.
No Intervention: Control
The control group will be given verbal information as a routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: 1 hour
Child Anxiety Scale: E This scale is for children ages 4-10. Children are told, "Imagine all your anxious or nervous feelings being in the bulb or bottom part of the thermometer" or "If you are a little anxious or tense, feelings may go up a little bit on the thermometer. If you are very, very anxious or tense, feelings may go all the way to the top. Put a line on the thermometer to show how anxious or nervous you are." To measure state anxiety, the child is asked to mark what he or she is feeling "right now."
1 hour
Fear level
Time Frame: 1 hour
Child Fear Scale: This scale includes 5 different facial expressions. This scale is scored between 0-4 and is stated to be a reliable and valid measurement tool in the assessment of fear.
1 hour
Pain level
Time Frame: 1 hour
Numerical Pain Scale, this method for determining the intensity of pain aims to have the patient describe his pain with numbers. In numerical scales, the absence of pain (0) is evaluated as unbearable pain (10).
1 hour
Satisfaction level
Time Frame: 1 hour
The Child Satisfaction Scale was developed by researchers in line with the literature in a way that child patients can easily understand. The numbers between 0 and 10, which children will indicate by circling the point corresponding to their satisfaction with the education provided, are placed on a horizontal line. A score of 0 on the scale indicates "not satisfied at all" and a score of 10 indicates "extremely satisfied". In addition, there is a visual reflecting the degree of satisfaction in the places where the points are located.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Investigators

  • Principal Investigator: Atiye Karakul, Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Actual)

January 6, 2026

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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