Mindfulness-based Virtual Reality Intervention

Nanjing University of Traditional Chinese Medicine (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

Through virtual reality technology and mindfulness therapy, we can intervene the patients with Hematologic Neoplasms during chemotherapy, hoping to improve their symptoms and self-efficacy.

Condition or Disease Intervention/Treatment Phase
  • Device: virtual reality device

Detailed Description

In recent years, the intervention method of giving mindfulness has achieved good results in the management of symptoms related to cancer patients, but the compliance of patients with conventional mindfulness intervention is low. The virtual reality intervention based on mindfulness can effectively mobilize the enthusiasm of patients to participate in research and the compliance of mindfulness training. We aim to combine virtual reality with mindfulness intervention to intervene patients with hematologic neoplasms during chemotherapy, To improve their symptoms.

Study Design

Study Type:
Anticipated Enrollment :
110 participants
Intervention Model:
Parallel Assignment
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Mindfulness-based Virtual Reality Intervention on the Symptoms Associated With Hematologic Neoplasms Patients During Chemotherapy
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual reality+Mindfulness

Intervention method combining virtual reality technology and mindfulness therapy, twice a week, lasting for 7 weeks

Device: virtual reality device
mindfulness combined with virtual reality
Other Names:
  • Mindfulness
  • No Intervention: Mindfulness

    Intervention method of mindfulness therapy, twice a week, lasting for 7 weeks

    Outcome Measures

    Primary Outcome Measures

    1. MDASI-C [up to 7 weeks]

      Symptom burden was assessed using the Chinese version of the M. D. Anderson Symptom Inventory (MDASI-C),39 which is a self-report scale consisting of two domains. The first domain is named "core symptom severity items" and has 13 symptoms. Each symptom is rated on an 11-point scale (0-10) to indicate the presence and severity of the symptom, with 0 indicating "not present" and 10 indicating "as bad as you can imagine." Each symptom is rated based on the severity of the symptom, at its worst, in the last 24 h. The second domain is named "six symptoms interference items" and includes ratings of how much symptoms interfered with different aspects of the survivor's life in the last 24 h. The interference items are also rated on a scale of 0-10, with 0 indicating "did not interfere" and 10 indicating "interfered completely." A score of 0-3 indicated a mild level, 4-6 indicated a moderate level, and 7-10 indicated a severe level of symptom severity or interference.

    2. Hospital Anxiety and Depression Scale (HADS) [up to 7 weeks]

      The hospital anxiety and depression scale The HADS was compiled by Zigmond AS Which was used to detect states of depression and anxiety in the setting of an hospital medical outpatient clinic . It is a 14-question instrument, with each question being scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression.

    Secondary Outcome Measures

    1. the self-management efficacy scale (C-SUPPH) [up to 7 weeks]

      the self-management efficacy scale (C-SUPPH),The C-SUPPH scale consisted of 28 items in three dimensions: self-decompression, self-decision-making, and positive attitude, with each item scoring 1-5 points and a total score of 28-140 points. The higher the total score is, the higher the self-efficacy is.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Clinical diagnosis of Hematologic Neoplasms(leukemia, lymphoma or multiple myeloma) and receiving chemotherapy

    • Hospitalized for more than 4 weeks

    • Have normal communication ability, clear consciousness, and willing to participate in this study

    Exclusion Criteria:
    • People are cognitive dysfunction and audio-visual dysfunction

    • Have mental problems or have reported mental disorders

    Contacts and Locations


    Site City State Country Postal Code
    1 the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China

    Sponsors and Collaborators

    • Nanjing University of Traditional Chinese Medicine


    • Study Director: yuxi Zhang, The First Affiliated Hospital with Nanjing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Wu Yuan, master, Nanjing University of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 2021-SR-586
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Nov 1, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 1, 2022