VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK

Study Overview
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Brief Summary
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Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.

Detailed Description
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This study is a randomized controlled trial. We recruit 180 children with cancer who are aged 9 to 18 and Chinese speaking and allocate them into experimental and control group. The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The control group will receive no intervention.

Official Title
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The Use of a Virtual Reality Device (HypnoVR®) to Improve Chemotherapy-induced Nausea and Vomiting, Sleep Quality and Pain Among Children With Cancer in Hong Kong

Conditions
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Pain, Neoplasms, Child, Nausea, Vomiting, Sleep Hygiene

Intervention / Treatment
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* Device: Hypnosis VR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 9 to 18 Can read Chinese and speak Cantonese diagnosed with cancer Exclusion Criteria: with mental disabilities or cognitive dysfunction as identified in the medical record

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis VR<br>The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. | Device: Hypnosis VR<br>* Children will be required to wear a VR gadget for hypnosis when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The duration is 15 minutes.<br>|
| No Intervention: Control<br>The control group will receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up | Children will be required o fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 6-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea. | at the 6-month follow-up | 
| Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up | Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality. | at the 6-month follow-up | 
| Visual Analogue Pain Scale (VAS) at the 6-month follow-up | Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 6-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain. | at the 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Nausea Assessment Tool (PeNAT) at baseline | Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline. The score ranges from 1 to 4. Higher scores represent a more severe nausea. | at baseline | 
| The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up | Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up.The score ranges from 1 to 4. Higher scores represent a more severe nausea. | at 1-month follow-up | 
| The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up | Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea. | at 3-month follow-up | 
| Pittsburgh Sleep Quality Index (PSQI) at baseline | Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at baseline. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality. | at baseline | 
| Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up | Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality. | at 1-month follow-up | 
| Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up | Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality. | at 3-month follow-up | 
| Visual Analogue Pain Scale (VAS) at baseline | Children will be required to fill in the Visual Analogue Pain Scale (VAS) at baseline. The score ranges from 0 to 10. Higher scores represent a higher level of pain. | at baseline | 
| Visual Analogue Pain Scale (VAS) at 1-month follow-up | Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 1-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain. | at 1-month follow-up | 
| Visual Analogue Pain Scale (VAS) at 3-month follow-up | Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 3-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain. | at 3-month follow-up |