Hematopoietic Stem Cell TransplantationNCT04275830
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
A study testing Baseline Surveys and Heart rate variability biofeedback in people with Hematopoietic Stem Cell Transplantation and Bone Marrow Transplant, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Bone Marrow Transplant, Heart Rate Variability
- What is being tested?
- Baseline Surveys and Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation, Bone Marrow Transplant, Heart Rate Variability, Autonomic Nervous System, Stress, Mood
- Being tested
- Baseline Surveys, Heart rate variability biofeedback, Heart rate variability waitlist and Digital storytelling Control intervention
- Keywords
- Digital Storytelling, Narrative, Cancer patients, Bone marrow transplant, Psychosocial health, Heart rate variability biofeedback
- Medical subject headings
- Emotional Regulation, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline SurveysBehavioural
Also called Baseline questionnaire
Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.
Heart rate variability biofeedbackBehavioural
Participants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a "priming" experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention.
Heart rate variability waitlist and Digital storytelling Control interventionBehavioural
Also called Narrative-based storytelling
Four Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (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). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2.
| Study group | Role | What they receive |
|---|---|---|
| Baseline and HRVB+DS group | Experimental | 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). Receives: Behavioral: Baseline Surveys; Behavioral: Heart rate variability biofeedback |
| Baseline and HRVB waitlist +DS control group | Other | 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. Receives: Behavioral: Baseline Surveys; Behavioral: Heart rate variability waitlist and Digital storytelling Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1), 2 weeks after (T2)
Secondary outcomes (1)
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.
Measured: Baseline (T1), 2 weeks after (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start4 Feb 2020
- Primary completion31 Dec 2021
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- HonorHealth Research Institute
- Responsible party
- Principal investigator, Wonsun (Sunny) Kim, Ph.D, Arizona State University
- Investigators
- Sunny Kim, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275830
- Sponsor's protocol ID
- STUDY00010085
- Other IDs
- PG12840
- Status last verified
- May 2022
- First submitted
- 17 Feb 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients
- ClinicalTrials.gov ID
- NCT04275830
- Acronym / sponsor ID
- STUDY00010085
- Conditions
- Hematopoietic Stem Cell Transplantation, Bone Marrow Transplant, Heart Rate Variability, Autonomic Nervous System, Stress, Mood
- Keywords
- Digital Storytelling, Narrative, Cancer patients, Bone marrow transplant, Psychosocial health, Heart rate variability biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- HonorHealth Research Institute
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline and HRVB+DS group | Experimental | Behavioral: Baseline Surveys, Behavioral: Heart rate variability biofeedbackIn-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). |
| Baseline and HRVB waitlist +DS control group | Other | Behavioral: Baseline Surveys, Behavioral: Heart rate variability waitlist and Digital storytelling Control interventionIn-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline SurveysAlso: Baseline questionnaireBaseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance. | Behavioural | Baseline and HRVB waitlist +DS control group, Baseline and HRVB+DS group |
| Heart rate variability biofeedbackParticipants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a "priming" experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention. | Behavioural | Baseline and HRVB+DS group |
| Heart rate variability waitlist and Digital storytelling Control interventionAlso: Narrative-based storytellingFour Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (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). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2. | Behavioural | Baseline and HRVB waitlist +DS control group |
Primary outcome
Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks
Time frame: Baseline (T1), 2 weeks after (T2)
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.
1 secondary outcome
Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks
Time frame: Baseline (T1), 2 weeks after (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunny Kim, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Surveys and Heart rate variability biofeedback in people with Hematopoietic Stem Cell Transplantation and Bone Marrow Transplant, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks (time frame: Baseline (T1), 2 weeks after (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.