The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children

NCT ID: NCT06655103

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-11-30

Brief Summary

In this study, which is planned to be conducted in a randomized controlled experimental design, nonpharmacological methods (educational film shown with virtual reality goggles and cartoon shown with virtual reality goggles) applied to children aged 5-10 years who will receive intrathecal chemotherapy treatment before intrathecal chemotherapy treatment were evaluated. It is aimed to determine the effect on pre-procedure fear and post-procedure pain.

The study is planned to be conducted between November 2024 and November 2025. The population of the study will consist of children between the ages of 5-10 years who receive inpatient treatment in the Pediatric Hematology Clinic of Izmir Ege University Hospital (Health Practice and Research Center). Random sampling method and stratified randomization method will be used for sample selection. In the calculation of the sample size of the study, using G-Power 3.1.9.7 program; type 1 error (α) 0.05, power (1- β) 99% and Cohen's effect size (δ) 0.5, the sample size to represent the main mass was determined as 90 children for this study. However, when the dropout rate is set as 10% for data loss that may occur in the study, the minimum number to be reached for the study is targeted as 99 (intervention group 1 n=33, intervention group 2 n=33, control group n=33).

Research data will be collected after project acceptance. In all three groups, children and their parents will be informed before the study and their written and verbal consent will be obtained. Data will be collected by using the "Introductory Information Form", "Intervention Follow-up Form" and "Child Fear Scale (CFS)", "Wong Baker FACES (WB-FACES) Pain Rating Scale" and "Visual Analog Scale (VAS)" prepared by the researchers with the feedback of nurses, parents and children.

Statistical analyses will be performed using IBM SPSS Statistics 26.0 (IBM SPSS Statistics for Windows) package program. The significance level will be set as 0.05 in all analyzes. In the study, numerical data will be calculated using mean, standard deviation, median, minimum, maximum values and categorical data will be calculated using frequency and ratio values.

With the nonparametric Brunner-Langer model, the before-after change (group effect, before-after effect and interaction effect) of fear scores in the educational film, cartoon and control groups will be examined using R 3.3.1 software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org). In order to visually examine this change, the 'relative effects' graph (since the nonparametric method is used) will be utilized.

When the Brunner-Langer model shows that the before-after change in the groups is not similar (interaction < 0.05), the before-after comparison in each group will be made separately with the Wilcoxon sign test, and the differences between the groups will be compared with the Kruskal-Wallis test by taking the after-before difference. After Kruskal-Wallis, pairwise comparisons will be made with the Dunn test, and then Bonferroni correction will be used for p values. The agreement between the measurements of Nurses, Parents and Children will be evaluated by Intraclass Correlation (ICC) analysis.

Conditions

Injections, Spinal; Child, Only; Virtual Reality; Fear; Pain; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group shown educational movie with virtual reality glasses

Measurements will be performed in three stages. In the first measurement; electrodermal activity, pulse, respiration and oxygen (O2) saturation values together with fear and pain scales 30 minutes before IT chemotherapy treatment without any intervention, in the second measurement; Electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales after the application of virtual reality goggles 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

Group Type: EXPERIMENTAL

Educational movie

Intervention Type: OTHER

There are three groups in this research. The 1st group will be shown an educational movie about intrathecal chemotherapy treatment before intrathecal chemotherapy treatment, the 2nd group will be shown a cartoon movie before intrathecal chemotherapy treatment, and the 3rd group will not receive any intervention before intrathecal chemotherapy treatment. In all groups, measurements will be made in parallel; fear and pain scales as well as electrodermal activity, pulse, respiration and O2 saturation values 30 minutes before IT chemotherapy treatment, in the second measurement; In the second measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

Group watching cartoons with virtual reality glasses

Measurements will be performed in three stages. In the first measurement; electrodermal activity, pulse, respiration and oxygen (O2) saturation values together with fear and pain scales 30 minutes before IT chemotherapy treatment without any intervention, in the second measurement; Electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales after the application of virtual reality goggles 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

Group Type: EXPERIMENTAL

Educational movie

Intervention Type: OTHER

There are three groups in this research. The 1st group will be shown an educational movie about intrathecal chemotherapy treatment before intrathecal chemotherapy treatment, the 2nd group will be shown a cartoon movie before intrathecal chemotherapy treatment, and the 3rd group will not receive any intervention before intrathecal chemotherapy treatment. In all groups, measurements will be made in parallel; fear and pain scales as well as electrodermal activity, pulse, respiration and O2 saturation values 30 minutes before IT chemotherapy treatment, in the second measurement; In the second measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

The group that received routine clinical care without any intervention

Measurements will be performed in three stages parallel to the treatment groups. In the first measurement; electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales 30 minutes before IT chemotherapy treatment without any intervention, in the second measurement; In the second measurement, electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values together with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational movie

There are three groups in this research. The 1st group will be shown an educational movie about intrathecal chemotherapy treatment before intrathecal chemotherapy treatment, the 2nd group will be shown a cartoon movie before intrathecal chemotherapy treatment, and the 3rd group will not receive any intervention before intrathecal chemotherapy treatment. In all groups, measurements will be made in parallel; fear and pain scales as well as electrodermal activity, pulse, respiration and O2 saturation values 30 minutes before IT chemotherapy treatment, in the second measurement; In the second measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales 15 minutes before IT chemotherapy, and in the third measurement, electrodermal activity, pulse, respiration and O2 saturation values along with fear and pain scales will be evaluated within 30-60 minutes after IT chemotherapy treatment (when the sedation effect is over).

Intervention Type: OTHER

Other Intervention Names

Cartoons; Without any intervention

Eligibility Criteria

Inclusion Criteria

• 5-10 years old
• Family's acceptance to participate in the research
• The child's willingness to participate in the research
• Absence of a pancytopenic period
• No sensory loss
• Developed language skills/no communication problems
• Lack of a psychological diagnosis Cognitive abilities are developed in an age-appropriate manner
• Having not used any anelgesic drug in the last four hours

Exclusion Criteria

• The child has an infection that requires isolation
• The child wears glasses
• Child removes virtual reality goggles applied before intrathecal chemotherapy treatment
• The child does not want to fill in the scales after the application
• The child or parent wants to leave the study
• The child has a physical and psychological deficit that prevents him/her from wearing the glasses that will be worn on his/her head in order to watch virtual reality

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Aycin Ezgi ONEL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University

Izmir, BORNOVA, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ayçin Ezgi ONEL, Research Assistant

Role: CONTACT

aycinezgiakaydin@gmail.com

+90 (543)6561920

Facility Contacts

Aycin Ezgi ONEL, Research Assistant

Role: primary

aycin.ezgi.onel@ege.edu.tr

+90 (543)6561920

Other Identifiers

EGEUNIVERSITY-ONEL-001

Identifier Type: -

Identifier Source: org_study_id