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

NCT07537062 | Recruiting DMC

• 1 other identifier: 2025/355
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Keywords

pediatrıc cancer, virtual reality glasses, intrathecal chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

group using virtual reality glasses

EXPERIMENTAL

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

Interventions

virtual reality glasses OTHER

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.

group using virtual reality glasses

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• outside the 4-10 age range,
• have a chronic or genetic illness,
• have an intellectual, visual, or hearing impairment,
• cannot adapt to virtual reality glasses,
• are uncooperative (both themselves and their parents),
• 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.

You may not qualify if:

• outside the 4-10 age range,
• have a chronic or genetic illness,
• have an intellectual, visual, or hearing impairment,
• cannot adapt to virtual reality glasses,
• are uncooperative (both themselves and their parents),
• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Eda Kalaycı

CONTACT

+905349538932; eda_kalayci937@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)