Mindfulness-based Virtual Reality Intervention
Primary Purpose
Hematologic Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
virtual reality device
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Neoplasms
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
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality+Mindfulness
Mindfulness
Arm Description
Intervention method combining virtual reality technology and mindfulness therapy, twice a week, lasting for 7 weeks
Intervention method of mindfulness therapy, twice a week, lasting for 7 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05602051
First Posted
October 26, 2022
Last Updated
October 28, 2022
Sponsor
Nanjing University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05602051
Brief Title
Mindfulness-based Virtual Reality Intervention
Official Title
Efficacy of Mindfulness-based Virtual Reality Intervention on the Symptoms Associated With Hematologic Neoplasms Patients During Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality+Mindfulness
Arm Type
Experimental
Arm Description
Intervention method combining virtual reality technology and mindfulness therapy, twice a week, lasting for 7 weeks
Arm Title
Mindfulness
Arm Type
No Intervention
Arm Description
Intervention method of mindfulness therapy, twice a week, lasting for 7 weeks
Intervention Type
Device
Intervention Name(s)
virtual reality device
Other Intervention Name(s)
Mindfulness
Intervention Description
mindfulness combined with virtual reality
Primary Outcome Measure Information:
Title
MDASI-C
Description
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.
Time Frame
up to 7 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
up to 7 weeks
Secondary Outcome Measure Information:
Title
the self-management efficacy scale (C-SUPPH)
Description
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.
Time Frame
up to 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Wu
Phone
18895611517
Email
1528046998@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuxi Zhang
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuxi Zhang
Phone
13584031657
Email
zhangyuxi830@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness-based Virtual Reality Intervention
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