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

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04853303
• Other study ID #: hypnoVR-NVSP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2021
• Source: The Hong Kong Polytechnic University
• Contact: Eva Ho, PhD
• Phone: 27666417
• Email: kyanho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Nausea
• Neoplasms
• Pain
• Sleep Hygiene
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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