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

Not Applicable

Not yet recruiting

• Conditions: Neoplasms; Sleep Hygiene; Pain; Child; Vomiting; Nausea
• Interventions: Device: Hypnosis VR

• Registration Number: NCT04853303
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20
• Study Start: 2021-09-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis VR	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.

Primary Outcome Measures

Name	Time	Method
The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up	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.
Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up	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.
Visual Analogue Pain Scale (VAS) at the 6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
The Pediatric Nausea Assessment Tool (PeNAT) at baseline	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.
The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up	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.
The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up	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.
Pittsburgh Sleep Quality Index (PSQI) at baseline	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.
Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up	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.
Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up	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.
Visual Analogue Pain Scale (VAS) at baseline	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.
Visual Analogue Pain Scale (VAS) at 1-month follow-up	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.
Visual Analogue Pain Scale (VAS) at 3-month follow-up	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.