Mindfulness-based Virtual Reality Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Device: virtual reality device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality+Mindfulness<br>Intervention method combining virtual reality technology and mindfulness therapy, twice a week, lasting for 7 weeks | Device: virtual reality device<br>* mindfulness combined with virtual reality<br>* Other names: Mindfulness;|
| No Intervention: Mindfulness<br>Intervention method of mindfulness therapy, twice a week, lasting for 7 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDASI-C | 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. | up to 7 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | 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. | up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the self-management efficacy scale (C-SUPPH) | 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. | up to 7 weeks |