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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Pain; Nausea; Vomiting; Child; Sleep Hygiene
• Intervention / Treatment: Device: Hypnosis VR

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Lam, PhD; Phone Number: 27666420; Email: kwkatlam@polyu.edu.hk
• Study Contact Backup: Name: Eva Ho, PhD; Phone Number: 27666417; Email: kyanho@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis VR; 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; 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.
No Intervention: Control; The control group will receive no intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Eva Ho, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: hypnoVR-NVSP

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