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

Primary Purpose

Neoplasms, Child, Nausea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnosis VR
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hypnosis VR

    Control

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    April 16, 2021
    Last Updated
    May 18, 2021
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04853303
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Child, Nausea, Vomiting, Sleep Hygiene, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypnosis VR
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group will receive no intervention.
    Intervention Type
    Device
    Intervention Name(s)
    Hypnosis VR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up
    Description
    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.
    Time Frame
    at the 6-month follow-up
    Title
    Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up
    Description
    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.
    Time Frame
    at the 6-month follow-up
    Title
    Visual Analogue Pain Scale (VAS) at the 6-month follow-up
    Description
    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.
    Time Frame
    at the 6-month follow-up
    Secondary Outcome Measure Information:
    Title
    The Pediatric Nausea Assessment Tool (PeNAT) at baseline
    Description
    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.
    Time Frame
    at baseline
    Title
    The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up
    Description
    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.
    Time Frame
    at 1-month follow-up
    Title
    The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up
    Description
    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.
    Time Frame
    at 3-month follow-up
    Title
    Pittsburgh Sleep Quality Index (PSQI) at baseline
    Description
    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.
    Time Frame
    at baseline
    Title
    Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up
    Description
    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.
    Time Frame
    at 1-month follow-up
    Title
    Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up
    Description
    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.
    Time Frame
    at 3-month follow-up
    Title
    Visual Analogue Pain Scale (VAS) at baseline
    Description
    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.
    Time Frame
    at baseline
    Title
    Visual Analogue Pain Scale (VAS) at 1-month follow-up
    Description
    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.
    Time Frame
    at 1-month follow-up
    Title
    Visual Analogue Pain Scale (VAS) at 3-month follow-up
    Description
    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.
    Time Frame
    at 3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eva Ho, PhD
    Phone
    27666417
    Email
    kyanho@polyu.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katherine Lam, PhD
    Phone
    27666420
    Email
    kwkatlam@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva Ho, PhD
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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