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临床试验/NCT05602051
NCT05602051招募中不适用

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

Nanjing University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • People are cognitive dysfunction and audio-visual dysfunction
  • Have mental problems or have reported mental disorders

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: 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

时间窗: 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.

次要结局

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

研究者

发起方
Nanjing University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Yuan

master

Nanjing University of Traditional Chinese Medicine

研究点 (1)

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