Clinical trial · Interventional
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autonomic Nervous System | — | UNRESOLVED | — |
| Bone Marrow Transplant | — | UNRESOLVED | — |
| Communication Research | — | UNRESOLVED | — |
| Emotion Regulation | — | UNRESOLVED | — |
| Heart Rate Variability | — | UNRESOLVED | — |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Mood | — | UNRESOLVED | — |
| Narrative | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline Surveys | Behavioral | — | UNRESOLVED |
| Heart rate variability biofeedback | Behavioral | — | UNRESOLVED |
| Heart rate variability waitlist and Digital storytelling Control intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Baseline and HRVB+DS 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).
- interventionNames
- Behavioral: Baseline Surveys
- Behavioral: Heart rate variability biofeedback
- type
- OTHER
- label
- Baseline and HRVB waitlist +DS control 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available