The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

Arizona State University (ASU)

Status: Completed

Conditions: Bone Marrow Transplant; Narrative; Hematopoietic Stem Cell Transplantation; Communication Research; Emotion Regulation; Mood; Heart Rate Variability; Autonomic Nervous System; Psychological Distress; Stress

Treatments: Behavioral: Baseline Surveys; Behavioral: Heart rate variability waitlist and Digital storytelling Control intervention; Behavioral: Heart rate variability biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04275830

STUDY00010085

PG12840 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Baseline and HRVB+DS group

Experimental group

Description:

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to HRVB+DS arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend either a group or one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will also be asked to watch four digital stories of other HCT patients (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).

Treatment:

Behavioral: Heart rate variability biofeedback

Behavioral: Baseline Surveys

Baseline and HRVB waitlist +DS control group

Other group

Description:

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to HRVB waitlist +DS control arm. After the baseline data collection, during two weeks, they will be provided four digital stories of other HCT patients sharing their experiences (challenges, feelings, strategies, coping, each 2-3 minutes long). At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Treatment:

Behavioral: Heart rate variability waitlist and Digital storytelling Control intervention

Behavioral: Baseline Surveys