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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04853303
Other study ID # hypnoVR-NVSP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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