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Clinical Trials/NCT05602051
NCT05602051
Recruiting
Not Applicable

Efficacy of Mindfulness-based Virtual Reality Intervention on the Symptoms Associated With Hematologic Neoplasms Patients During Chemotherapy

Nanjing University of Traditional Chinese Medicine1 site in 1 country110 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematologic Neoplasms
Sponsor
Nanjing University of Traditional Chinese Medicine
Enrollment
110
Locations
1
Primary Endpoint
Hospital Anxiety and Depression Scale (HADS)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing University of Traditional Chinese Medicine
Responsible Party
Principal Investigator
Principal Investigator

Wu Yuan

master

Nanjing University of Traditional Chinese Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale (HADS)

Time Frame: 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.

MDASI-C

Time Frame: 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.

Secondary Outcomes

  • the self-management efficacy scale (C-SUPPH)(up to 7 weeks)

Study Sites (1)

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