The EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR and PHYSİOLOGICAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY

THE EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR, and PHYSİOLOGİCAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY

This study was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. The main questions that the study aimed to answer are as follows:

• Could virtual reality glasses affect the fear experienced by children undergoing intrathecal chemotherapy?
• Could virtual reality glasses affect the anxiety experienced by children undergoing intrathecal chemotherapy?
• Does virtual reality goggles have an effect on the physiological parameters of children undergoing intrathecal chemotherapy? Researchers will compare the effects of virtual reality glasses on fear, anxiety, and physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) in children with cancer undergoing intrathecal chemotherapy to a control group that will not receive any intervention.

Cancer patients participating in the study will be given virtual reality glasses before intrathecal chemotherapy treatment.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: virtual reality glasses

Detailed Description

Cancer is a chronic disease with a long follow-up and treatment process that profoundly affects the lives of children and their families. Chemotherapy (CT) is one of the frequently used methods in cancer treatment. In children with cancer, CT is administered intraarterial, intraperitoneal, intrapleural, intravenous, intramuscular, subcutaneous, oral, and intrathecal. Intrathecal CT is a method developed to cross the blood-brain barrier after the administration of systemic chemotherapy. Intrathecal CT is frequently used in pediatric oncology clinics and can cause pain, stress, anxiety, and fear in children . Before intrathecal CT, various distraction methods can be used to reduce the stress, anxiety, and fear experienced by the child. Distraction is one of the non-pharmacological methods used to better control and reduce stress, anxiety, and fear by focusing the individual's attention elsewhere. Due to its non-invasive nature and lack of known side effects, distraction methods have become the most frequently preferred methods in recent years; Examples of distraction methods include blowing a pinwheel, watching cartoons/animations and playing games on a phone/computer, inflating balloons, reading books, counting numbers, listening to music, kaleidoscopes, medical puppets, distraction cards, and virtual reality glasses (VRG). VRG, which can alter visual, auditory, and tactile sensations by creating a perception of being in a different environment, isolates the individual from real life by showing digital images (games, animations, etc.) through a headset with a lens close to the eyes. At the same time, individuals can be immersed in the virtual world by wearing headphones to prevent the perception of sounds in the environment. In these aspects, VRG is a different method from other distraction methods in that it combines multiple sensory experiences and maximizes the sense of attention. No study has been found that uses VRG to reduce anxiety, fear, and anxiety experienced by children before intrathecal chemotherapy. Therefore, this study was planned to determine the effect of pre-operative SGG (Supplementary Endoscopic Glycemia) on anxiety, fear, and physiological parameters experienced by children aged 4-10 years before intrathecal chemotherapy.

Research Hypotheses

The application of SGG to children aged 4-10 years undergoing intrathecal chemotherapy has the following effects:

H1: It has an effect on pre-operative anxiety.

H2: It has an effect on pre-operative fear.

H3: It has an effect on pre-operative physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eda Kalaycı; Phone Number: +905349538932; Email: eda_kalayci937@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye), 38000
    • Recruiting
    • Erciyes University
    • Principal Investigator: eda kalaycı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. outside the 4-10 age range,
2. have a chronic or genetic illness,
3. have an intellectual, visual, or hearing impairment,
4. cannot adapt to virtual reality glasses,
5. are uncooperative (both themselves and their parents),
6. neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.

Exclusion Criteria:

1. outside the 4-10 age range,
2. have a chronic or genetic illness,
3. have an intellectual, visual, or hearing impairment,
4. cannot adapt to virtual reality glasses,
5. are uncooperative (both themselves and their parents),
6. neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: group using virtual reality glasses; In this study, children and their families who meet the inclusion criteria will be informed about the use of Virtual Reality Glasses, and the researcher will obtain an "Informed Consent Form." Before intrathecal chemotherapy, the Child and Family Demographic Characteristics Form and scales (thus determining the children's predicted levels of fear and anxiety before the procedure) will be administered to the children by the researcher, and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be recorded by the researcher. Then, the children will be fitted with Virtual Reality Glasses by the researcher and shown a selected animation film (approximately 15 minutes long). Five minutes after the child finishes watching the video, the physiological parameters will be recorded again, and the scales will be administered by the researcher.

Other: virtual reality glasses; In this study, a Virtual Reality headset (Meta Quest 2 VR Headset) will be used to show an animated film to a child before intrathecal chemotherapy. The device is compatible with Android operating systems. Activated by applications installed on the device, the VR headset divides the image into two equal windows, providing the necessary viewfinder range for panoramic viewing. No power or connection unit is required during use. The distance between the eye and the lens is adjustable. The VR headset consists of a headset and controllers. The headset can be adjusted to the individual after being fitted. After downloading the application to be used with the VR headset, the 360-degree image automatically appears on the screen. Watching videos with the VR headset does not require an internet connection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Child Anxiety Scale-State Scale (CAS-S)	The Child Anxiety Scale-State Scale (CAS-S): This visual scale, designed for children aged 4-10, resembles a thermometer, featuring a lightbulb at the bottom and 10 horizontal lines leading upwards. When administering the scale, explain to the children: "Imagine all your anxious or tense feelings are at the top of the thermometer (point to it with your finger)," "If you are slightly anxious or nervous, the feelings may increase slightly (move your finger upwards on the scale)," "If you are very, very anxious or tense, the feelings may reach the top of the lines (move your finger to the top)," "Put a line that helps us understand how anxious or tense you feel." Before using the CAS-S, check if the child has counting and sequencing skills, specifically whether they know that 5 is greater than 2. If they do not know this, the scale cannot be administered to the child.	10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatrıc cancer, virtual reality glasses, intrathecal chemotherapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2025/355

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