Mindfulness-based Virtual Reality Intervention

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wu; Phone Number: 18895611517; Email: 1528046998@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: yuxi Zhang; Phone Number: 13584031657; Email: zhangyuxi830@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing University of Traditional Chinese Medicine
• Investigators: Study Director: yuxi Zhang, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 2021-SR-586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No