Clinical trial NCT04275830: The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
Official title: The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Bone Marrow Transplant
Heart Rate Variability
Autonomic Nervous System
Stress
Mood
Psychological Distress
Emotion Regulation
Communication Research
Narrative
Keywords: Digital Storytelling
Narrative
Cancer patients
Bone marrow transplant
Psychosocial health
Heart rate variability biofeedback
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: HonorHealth Research Institute
First posted: 2020-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: This randomized controlled trial will explore the effects of an HRV biofeedback (HRVB) training session with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients. We will secondarily explore effects of a brief storytelling intervention, with or without the prior HRVB training. Two group of 10 HCT patients over the age of 18 will be recruited and enrolled into the study. The time of participating in this study will be 2-week proposed activities from the time of enrollment to completion. Specific participation will include baseline data collection (about 30 minutes), HRVB training session (30 minutes), watching and discussing stories (15 min for each week= 30 minutes) and one final data collection (about 30 minutes) at the end. For HRVB group, participants will be instructed to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period (about 140 minutes). Lab visit is required only twice for baseline data collection and final data collection. Other works will be via internet.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks
timeFrame: Baseline (T1), 2 weeks after (T2)
Secondary outcomes:
measure: Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks
timeFrame: Baseline (T1), 2 weeks after (T2)
Other outcomes:
measure: Changes from Baseline Depression at 2 weeks
timeFrame: Baseline (T1), 2 weeks after (T2)
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
Study officials:
affiliation: Arizona State University
name: Sunny Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: