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

NCT06698445 | Completed

• 1 other identifier: 2024-112
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear; Pain; Satisfaction

Keywords

anxiety; fear; pain; satisfaction; children

Outcome Measures

Primary Outcomes (4)

• Anxiety level

  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

  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

  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

  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

Study Arms (2)

Short Film Video

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will be given verbal information as a routine clinical practice.

Interventions

Short film video OTHER

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.

Short Film Video

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (8)

• Abdolkarimi B, Zareifar S, Golestani Eraghi M, Saleh F. Comparison Effect of Intravenous Ketamine with Pethidine for Analgesia and Sedation during Bone Marrow Procedures in Oncologic Children: A Randomized, Double-Blinded, Crossover Trial. Int J Hematol Oncol Stem Cell Res. 2016 Oct 1;10(4):206-211.

  PMID: 27928474 BACKGROUND

• Alonso Puig M, Alonso-Prieto M, Miro J, Torres-Luna R, Plaza Lopez de Sabando D, Reinoso-Barbero F. The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology. J Med Internet Res. 2020 Mar 30;22(3):e16013. doi: 10.2196/16013.

  PMID: 32224482 BACKGROUND

• Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.

  PMID: 31391620 BACKGROUND

• Balasubramanian M, Sangoi NN. Utility of Bone Marrow Examination in Pediatric Age Group: Experience of a Tertiary Healthcare Centre in India. Cureus. 2022 Jul 20;14(7):e27056. doi: 10.7759/cureus.27056. eCollection 2022 Jul.

  PMID: 36000100 BACKGROUND

• Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.

  PMID: 38101311 BACKGROUND

• Bernier Carney KM, Jung SH, Iacob E, Lewis M, Linder LA. Communication of pain by school-age children with cancer using a game-based symptom assessment app: A secondary analysis. Eur J Oncol Nurs. 2021 Jun;52:101949. doi: 10.1016/j.ejon.2021.101949. Epub 2021 Mar 20.

  PMID: 33813185 BACKGROUND

• Comparcini D, Simonetti V, Galli F, Saltarella I, Altamura C, Tomietto M, Desaphy JF, Cicolini G. Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review. Cancers (Basel). 2023 Feb 3;15(3):985. doi: 10.3390/cancers15030985.

  PMID: 36765945 BACKGROUND

• Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;24(4):e30260. doi: 10.2196/30260.

  PMID: 35436209 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Atiye Karakul

  Tarsus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Patients who meet the sample selection criteria will be randomly and equally distributed into 2 groups (1st experimental group, 2nd control group) using a computer program according to gender, age and whether or not KIA has been applied for the first time, thus providing simple stratified randomization.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: December 19, 2024
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)