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Spots Global Cancer Trial Database for The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

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Trial Identification

Brief Title: 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 ID: NCT04275830

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HonorHealth, Scottsdale, Arizona, United States

Contact Details

Name: Sunny Kim, PhD

Affiliation: Arizona State University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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