Clinical trial NCT04853303: VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neoplasms
Child
Nausea
Vomiting
Sleep Hygiene
Pain
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 180
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up
timeFrame: at the 6-month follow-up
measure: Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up
timeFrame: at the 6-month follow-up
measure: Visual Analogue Pain Scale (VAS) at the 6-month follow-up
timeFrame: at the 6-month follow-up
Secondary outcomes:
measure: The Pediatric Nausea Assessment Tool (PeNAT) at baseline
timeFrame: at baseline
measure: The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up
timeFrame: at 1-month follow-up
measure: The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up
timeFrame: at 3-month follow-up
measure: Pittsburgh Sleep Quality Index (PSQI) at baseline
timeFrame: at baseline
measure: Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up
timeFrame: at 1-month follow-up
measure: Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up
timeFrame: at 3-month follow-up
measure: Visual Analogue Pain Scale (VAS) at baseline
timeFrame: at baseline
measure: Visual Analogue Pain Scale (VAS) at 1-month follow-up
timeFrame: at 1-month follow-up
measure: Visual Analogue Pain Scale (VAS) at 3-month follow-up
timeFrame: at 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Eva Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References: