Stress Clinical Trial
Official title:
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
Verified date | May 2022 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.
Status | Completed |
Enrollment | 18 |
Est. completion date | February 4, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Patient Inclusion Criteria: - age 18 or older - recently underwent Hematopoietic cell transplantation (HCT) (within 3 months after hospital discharge) - must be able to speak, read, and write in English - access to a working phone and e-mail account - have a smart phone Patient Exclusion Criteria: - cognitive impairment that prohibits completion of study assessment visual or hearing impairment - other (e.g., provider non-approval or logistical constraints such as patient moving out of town) |
Country | Name | City | State |
---|---|---|---|
United States | HonorHealth | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | HonorHealth Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes from Baseline Depression at 2 weeks | Depression will be measured using the Center for Epidemiological Studies Depression Scale Revised (CESD-R-10) scale (10 items, 4-point Likert scale (0 = rarely or none of the time, 3= all of the times, Cronbach's a = .86). The higher values represent a worse depression. | Baseline (T1), 2 weeks after (T2) | |
Primary | Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks | The Emwave Pro Plus device from HeartMath will be used to collect HRV data and heart rate using a 3-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of DS+ HRVB. In addition, HRV measures will be obtained for the 1-minute paced breathing period to understand the effects of paced breathing on HRV. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection. | Baseline (T1), 2 weeks after (T2) | |
Secondary | Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks | Psychological distress will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression. The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being. | Baseline (T1), 2 weeks after (T2) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05130944 -
Feasibility of Community Psychosocial Intervention for Women
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Recruiting |
NCT04038190 -
A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
|
Phase 2 | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Active, not recruiting |
NCT05998161 -
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
|
N/A | |
Completed |
NCT03728062 -
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Completed |
NCT06405789 -
The Effect of Yoga on Mindfulness and Perceived Stress
|
N/A | |
Recruiting |
NCT06002074 -
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Completed |
NCT05245409 -
Stress, EEG, ECG, and Chiropractic
|
N/A | |
Completed |
NCT04722367 -
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Completed |
NCT06057883 -
Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females
|
Phase 2 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Completed |
NCT05312749 -
The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students
|
N/A | |
Completed |
NCT05623826 -
Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager
|
N/A | |
Completed |
NCT04013451 -
The Kiss of Kindness Study II
|
N/A |