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

Not Applicable

Active, not recruiting

• Conditions: Anxiety and Fear; Pain; Satisfaction

• Registration Number: NCT06698445
• Lead Sponsor: Tarsus University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Study Start: 2024-12-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety level	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."
Fear level	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.
Pain level	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).
Satisfaction level	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.

Trial Locations

Locations (1)

Tarsus State Hospital; 🇹🇷 Mersin, Turkey