Injections, SpinalNCT06655103
The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children
A study testing Educational movie in people with Injections, Spinal and Child, Only, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Injections, Spinal, Child, Only, Virtual Reality
- What is being tested?
- Educational movie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 30 Nov 2025
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University
Izmir, BORNOVA, 35100
Aycin Ezgi ONEL, Research Assistant, +90 (543)6561920, aycin.ezgi.onel@ege.edu.tr
About this study
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).
Read more
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
- Being tested
- Educational movie
- Keywords
- Intrathecal, Child, Virtual reality, Fear, Pain, chemotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational movieOther
Also called Cartoons, Without any intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Group shown educational movie with virtual reality glasses | Experimental | 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). Receives: Other: Educational movie |
| Group watching cartoons with virtual reality glasses | Experimental | 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). Receives: Other: Educational movie |
| The group that received routine clinical care without any intervention | No 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Wong Baker FACES (WB-FACES) Pain Rating Scale: The WB-FACES scale was first developed by Donna Wong and Connie Baker in 1981 and updated in 1983. This scale is used for pain assessment in children between the ages of 3 and 18. A simple tool including five different facial expressions was created by taking into account the way children express their pain. This scale is used to determine the level of pain in children aged 3-18 years. It contains a total of 6 facial expressions and provides a rating scale between 0-10. It does not require word or numeric values and is reported to be a reliable and valid measurement tool in the evaluation of acute pain. As the score obtained from the scale increases, the severity of pain increases and as the score decreases, the severity decreases.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Pain
Visual Analog Scale (VAS): The Visual Analog Scale (VAS), developed by Price et al. (1983), is one of the widely used tools for pain assessment in children. The VAS is characterized by its ease of use and simple structure. It allows children to mark their pain on a line or a line. The scale consists of a line at one end indicating no pain and a line at the other end indicating excruciating pain. By marking their own pain, children determine how much pain they feel.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Fear
Child Fear Scale: The Facial Expressions of Fear Scale was developed by McKinley et al. (2003) as "The Faces Anxiety Scale" to measure the fear or anxiety of adults hospitalized in the intensive care unit. The Child Fear Scale was developed by McMurty et al. (2011) by adapting the Facial Expressions of Fear Scale to children. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and can be easily evaluated by researchers and health professionals who provide care/intervention to children. The scale was translated into Turkish by Gerçeker et al. in 2018. Content validity is the most frequently used method in the validity of measurement tools. The content validity index of the CQS was found to be 0.89.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Secondary outcomes (4)
Electrodermal activity
Electrodermal activity device: An electrodermal activity device is a biometric measurement tool that measures changes in electrical conductivity on the skin surface. This device is often used to study a person's emotional and physiological responses. In particular, EDA reflects changes in the skin's conductivity due to the activity of sweat glands, which is associated with states such as stress, fear, excitement or arousal. In this study, the electrodermal activity device will be used simultaneously with the Child Fear Scale to measure the fear experienced by children before, during and after intrathecal chemotherapy treatment.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Pulse
Pulseoximeter Calibrated pulseoximeter device will be used for pulse and O2 saturation measurements of children.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Respiration
Pulseoximeter Calibrated pulseoximeter device will be used for pulse and O2 saturation measurements of children.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
O2 saturation
Pulseoximeter Calibrated pulseoximeter device will be used for pulse and O2 saturation measurements of children.
Measured: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injections, SpinalStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aycin Ezgi ONEL, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655103
- Sponsor's protocol ID
- EGEUNIVERSITY-ONEL-001
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children
- ClinicalTrials.gov ID
- NCT06655103
- Acronym / sponsor ID
- EGEUNIVERSITY-ONEL-001
- Conditions
- Injections, Spinal, Child, Only, Virtual Reality, Fear, Pain, Chemotherapy
- Keywords
- Intrathecal, Child, Virtual reality, Fear, Pain, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 Oct 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group shown educational movie with virtual reality glasses | Experimental | Other: Educational movieMeasurements 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 watching cartoons with virtual reality glasses | Experimental | Other: Educational movieMeasurements 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). |
| The group that received routine clinical care without any intervention | No 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). |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Educational movieAlso: Cartoons, Without any interventionThere 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). | Other | Group shown educational movie with virtual reality glasses, Group watching cartoons with virtual reality glasses |
Primary outcome
Pain
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Wong Baker FACES (WB-FACES) Pain Rating Scale: The WB-FACES scale was first developed by Donna Wong and Connie Baker in 1981 and updated in 1983. This scale is used for pain assessment in children between the ages of 3 and 18. A simple tool including five different facial expressions was created by taking into account the way children express their pain. This scale is used to determine the level of pain in children aged 3-18 years. It contains a total of 6 facial expressions and provides a rating scale between 0-10. It does not require word or numeric values and is reported to be a reliable and valid measurement tool in the evaluation of acute pain. As the score obtained from the scale increases, the severity of pain increases and as the score decreases, the severity decreases.
Pain
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Visual Analog Scale (VAS): The Visual Analog Scale (VAS), developed by Price et al. (1983), is one of the widely used tools for pain assessment in children. The VAS is characterized by its ease of use and simple structure. It allows children to mark their pain on a line or a line. The scale consists of a line at one end indicating no pain and a line at the other end indicating excruciating pain. By marking their own pain, children determine how much pain they feel.
Fear
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Child Fear Scale: The Facial Expressions of Fear Scale was developed by McKinley et al. (2003) as "The Faces Anxiety Scale" to measure the fear or anxiety of adults hospitalized in the intensive care unit. The Child Fear Scale was developed by McMurty et al. (2011) by adapting the Facial Expressions of Fear Scale to children. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and can be easily evaluated by researchers and health professionals who provide care/intervention to children. The scale was translated into Turkish by Gerçeker et al. in 2018. Content validity is the most frequently used method in the validity of measurement tools. The content validity index of the CQS was found to be 0.89.
4 secondary outcomes
Electrodermal activity
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Pulse
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Respiration
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
O2 saturation
Time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational movie in people with Injections, Spinal and Child, Only, run by Ege University 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayçin Ezgi ONEL, Research Assistant (+90 (543)6561920, aycinezgiakaydin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Measurements will be performed 30 minutes before intrathecal chemotherapy (without any intervention to the child), 15 minutes before intrathecal chemotherapy (after application of virtual reality goggles), and 30-60 minutes after IT chemotherapy (after t). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.