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

Official title

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

Overview

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.

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).

Interventions

• 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 headse

Primary outcome measures

• The Child Anxiety Scale-State Scale (CAS-S) [Time frame: 10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Erciyes University — Kayseri

Identifiers

NCT: NCT07537062 · 2025/355

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗