Maternal StressNCT02119936
Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women
A study testing Heart Rate Variability Biofeedback Tool in people with Maternal Stress and Maternal Anxiety, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive functioning. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Stress, Maternal Anxiety, Maternal Health Services
- What is being tested?
- Heart Rate Variability Biofeedback Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patients are eligible for the study if they fulfill all the inclusion criteria specified below:
- Patient has signed the informed consent before any study specific procedures are performed.
- Patient is a pregnant female over 18 years of age that is an in-patient on the UNC Women's Hospital antepartum floor.
- Patient agrees to adhere to study requirements
Exclusion Criteria: Patients are not eligible for the study if they fulfill any of the exclusion criteria below:
- Does not speak English.
- Patient is not expected be on the antepartum floor of UNC Women's Hospital for at least 7 days.
- Patient's healthcare provider does not want the patient to participate for medical safety purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Heart Rate Variability Biofeedback as a Stress Reduction Tool for Hospitalized Pregnant Women at the University of North Carolina at Chapel Hill (UNC-CH)
Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive functioning. Additionally HRVB has been shown to significantly reduce anxiety features in women suffering from perinatal depression. The investigators hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy complications, who are at high risk for depression and anxiety.
Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk for depression and anxiety.
Procedures: The investigators plain to use a heart rate variability biofeedback tool to measure stress reduction in hospitalized expectant mothers. This tool will be coupled with validated surveys and scales, high frequency heart rate variability, saliva samples, and qualitative interviews to quantify the reduction in stress from the HRVB tool.
Read the detailed description
Background and Significance: Hospitalization during pregnancy is an unexpected interruption in the prenatal period that causes increased maternal anxiety and stress(MacMullen 1992). In a study of 129 women hospitalized for pregnancy complications, 25 met criteria for major depressive disorder(Brandon 2008). Such maternal depression is a risk factor for perinatal complications ranging from morbidity and mortality to neuropsychological developmental delays in the offspring(Poehlmann 2001). To date, however, few easily disseminated strategies have been identified to reduce stress among pregnant women.
To address this gap, the investigators plan a feasibility study of an easily-disseminated biofeedback tool to reduce stress among hospitalized expecting mothers(Beckham 2013). Converging evidence suggests that Heart Rate Variability Biofeedback (HRVB) can improve stress management and executive functioning (Association for Applied Psychophysiology and Biofeedback Inc 2011). Additionally, HRVB has recently been shown to reduce anxiety features in women suffering from perinatal depression at UNC (Beckham 2013). The investigators hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy complications, who are at high risk for depression and anxiety(Brandon 2008).
Objectives:
- To determine the feasibility of using HRVB among hospitalized pregnant women
- To measure the association between use of HRVB and maternal state anxiety.
- To measure the association between use of HRVB, biological markers of stress, indexed by salivary cortisol and oxytocin, and high frequency heart rate variability, measured using research-quality instruments
- To measure the effectiveness of HRVB in women with varying levels of clinical depression and anxiety
Study Design \& Methods: The investigators plan a pilot study to recruit 30 pregnant women who are receiving care on the antepartum floor of the North Carolina Women's Hospital.
At the baseline session,the investigators will consent each participant and then screen her for depression or anxiety. This screen will involve using the M.I.N.I Depression Module and the Edinburgh Postnatal Depression Screen (EPDS). Both assessments will be scored at baseline to determine if the participant has severe, moderate, or no clinical depression or anxiety. The investigators will also record if the participant is on anxiety or depression medication as apart of our screen. The investigators will also notes any medications given for other mental illness.
Once this screen is complete, the investigators will collect sociodemographic information and then proceed teach all the participants about biofeedback, how to use the HRVB device, coupled with deep breathing techniques to detach from stressful thoughts. The HRVB intervention will be administered by Carole Swanson, a registered nurse with extensive experience in maternity care, will complete the HeartMath® Interventions Certification Program(HeartMath LLC 2013). The certification provides detailed instruction on use of HRV Biofeedback for clinical care. The HeartMath device, the EmWave2, uses a heart rate sensor on the patient's earlobe to detect beat-to-beat variability, which is an index of vagal tone. The device is attached to a laptop computer to allow the user to view visual cues for deep breathing. The EmWave2 is currently used in clinical care in the inpatient psychiatry units at UNC hospitals.
Before and after each HRVB session, participants will complete three measures of current psychological distress (Spielberger State Anxiety Scale, Linear Analog Self Assessment, Warwick-Edinburgh Mental Well-Being scale). To measure biologic markers of stress, the investigators will collect saliva samples and measure blood pressure before and after administering HRVB. In addition information on the participants' high frequency heart rate variability will also be collected using the Single Channel 3991x Biolog, a research-quality measure of heart rate variability.
Participants will then be instructed to practice their deep breathing exercises for approximately ten minutes each day until the follow-up session and complete a brief log of these exercises. During this period participants will also be asked to complete validated inventories on perceived social support and life experiences (MOS Social Support Scale, Maternal Antenatal Attachment Scale and Adverse Childhood Experiences). At the follow up visit, approximately 5 to 7 days following the baseline session, administration of HRVB inventories on maternal mood, the saliva sample and measurement of high frequency heart rate variability will be repeated. The saliva sample will be used to measure salivary one or all of the following: oxytocin, alpha-amylase, and cortisol.
Finally the investigators will attempt a follow-up call with each participant six to eight weeks following discharge to measure continued use of HRVB techniques and satisfaction qualitative information on HRVB feasibility.
- Conditions
- Maternal Stress, Maternal Anxiety, Maternal Health Services
- Being tested
- Heart Rate Variability Biofeedback Tool
- Keywords
- Stress, Anxiety, Mental Health, Mental Health Services, Maternal Mental Health
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability Biofeedback ToolBehavioural
Also called emWave 2 (Heartmath)
The Heart Rate Variability Biofeedback tool (emWave 2) will capture heart rate variability (HRV) before and after deep breathing exercises are used among participants. Participants will be able to visualize changes in their HRV and then fill-out self-reported anxiety measures to determine if the breathing exercises and visualization of HRV affected anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Variability Biofeedback Tool | Experimental | Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction. Receives: Behavioral: Heart Rate Variability Biofeedback Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Using HRVB Among Hospitalized Pregnant Women
The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.
Measured: Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)
Secondary outcomes (5)
Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).
State-trait anxiety scores range from 40-80 with higher scores indicative of greater anxiety
Measured: Baseline to in-patient follow-up (5 to 7 days in between)
Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)
The investigators will measure HF-HRV in 1-minute segments during HRVB, and will test whether coherence score, as recorded by the HRVB device, correlates with HF-HRV.
Measured: Baseline to in-patient follow-up (5 to 7 days in between)
Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety
The investigators will stratify our population based on the depression screen used at the baseline visit. These groups will include those with severe, moderate, or lack of depression. The investigators will then compare these groups to the finds from the surveys on maternal mood and the difference noticed among the groups due to the HRVB tools.
Measured: Baseline to in-patient follow-up (5 to 7 days in between)
Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).
The Linear Analog Self-Assessment (LASA) form measures patient quality-of-life. Scores range from 6-30 with higher scores indicative of greater well-being.
Measured: Baseline to in-patient follow-up (5 to 7 days in between)
Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).
The Warwick Edinburgh Mental Well Being Scale is a 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.
Measured: Baseline to in-patient follow-up (5 to 7 days in between)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionOct 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal StressStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Samantha Meltzer-Brody, MD, MPH, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119936
- Sponsor's protocol ID
- 13-2051
- Status last verified
- May 2017
- First submitted
- 16 Apr 2014
- Last updated
- 19 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Beckham AJ, Greene TB, Meltzer-Brody S. A pilot study of heart rate variability biofeedback therapy in the treatment of perinatal depression on a specialized perinatal psychiatry inpatient unit. Arch Womens Ment Health. 2013 Feb;16(1):59-65. doi: 10.1007/s00737-012-0318-7. Epub 2012 Nov 25.
PubMed 23179141Brandon AR, Trivedi MH, Hynan LS, Miltenberger PD, Labat DB, Rifkin JB, Stringer CA. Prenatal depression in women hospitalized for obstetric risk. J Clin Psychiatry. 2008 Apr;69(4):635-43. doi: 10.4088/jcp.v69n0417.
PubMed 18312059MacMullen N, Dulski LA, Pappalardo B. Antepartum vulnerability: stress, coping, and a patient support group. J Perinat Neonatal Nurs. 1992 Dec;6(3):15-25. doi: 10.1097/00005237-199212000-00004. No abstract available.
PubMed 1295961Poehlmann J, Fiese BH. The interaction of maternal and infant vulnerabilities on developing attachment relationships. Dev Psychopathol. 2001 Winter;13(1):1-11. doi: 10.1017/s0954579401001018.
PubMed 11346045
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Heart Rate Variability Biofeedback as a Stress Reduction Tool for Hospitalized Pregnant Women at the University of North Carolina at Chapel Hill (UNC-CH)
- ClinicalTrials.gov ID
- NCT02119936
- Acronym / sponsor ID
- 13-2051
- Conditions
- Maternal Stress, Maternal Anxiety, Maternal Health Services
- Keywords
- Stress, Anxiety, Mental Health, Mental Health Services, Maternal Mental Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive functioning. Additionally HRVB has been shown to significantly reduce anxiety features in women suffering from perinatal depression. The investigators hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy complications, who are at high risk for depression and anxiety.
Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk for depression and anxiety.
Procedures: The investigators plain to use a heart rate variability biofeedback tool to measure stress reduction in hospitalized expectant mothers. This tool will be coupled with validated surveys and scales, high frequency heart rate variability, saliva samples, and qualitative interviews to quantify the reduction in stress from the HRVB tool.
Detailed description
Background and Significance: Hospitalization during pregnancy is an unexpected interruption in the prenatal period that causes increased maternal anxiety and stress(MacMullen 1992). In a study of 129 women hospitalized for pregnancy complications, 25 met criteria for major depressive disorder(Brandon 2008). Such maternal depression is a risk factor for perinatal complications ranging from morbidity and mortality to neuropsychological developmental delays in the offspring(Poehlmann 2001). To date, however, few easily disseminated strategies have been identified to reduce stress among pregnant women.
To address this gap, the investigators plan a feasibility study of an easily-disseminated biofeedback tool to reduce stress among hospitalized expecting mothers(Beckham 2013). Converging evidence suggests that Heart Rate Variability Biofeedback (HRVB) can improve stress management and executive functioning (Association for Applied Psychophysiology and Biofeedback Inc 2011). Additionally, HRVB has recently been shown to reduce anxiety features in women suffering from perinatal depression at UNC (Beckham 2013). The investigators hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy complications, who are at high risk for depression and anxiety(Brandon 2008).
Objectives:
- To determine the feasibility of using HRVB among hospitalized pregnant women
- To measure the association between use of HRVB and maternal state anxiety.
- To measure the association between use of HRVB, biological markers of stress, indexed by salivary cortisol and oxytocin, and high frequency heart rate variability, measured using research-quality instruments
- To measure the effectiveness of HRVB in women with varying levels of clinical depression and anxiety
Study Design \& Methods: The investigators plan a pilot study to recruit 30 pregnant women who are receiving care on the antepartum floor of the North Carolina Women's Hospital.
At the baseline session,the investigators will consent each participant and then screen her for depression or anxiety. This screen will involve using the M.I.N.I Depression Module and the Edinburgh Postnatal Depression Screen (EPDS). Both assessments will be scored at baseline to determine if the participant has severe, moderate, or no clinical depression or anxiety. The investigators will also record if the participant is on anxiety or depression medication as apart of our screen. The investigators will also notes any medications given for other mental illness.
Once this screen is complete, the investigators will collect sociodemographic information and then proceed teach all the participants about biofeedback, how to use the HRVB device, coupled with deep breathing techniques to detach from stressful thoughts. The HRVB intervention will be administered by Carole Swanson, a registered nurse with extensive experience in maternity care, will complete the HeartMath® Interventions Certification Program(HeartMath LLC 2013). The certification provides detailed instruction on use of HRV Biofeedback for clinical care. The HeartMath device, the EmWave2, uses a heart rate sensor on the patient's earlobe to detect beat-to-beat variability, which is an index of vagal tone. The device is attached to a laptop computer to allow the user to view visual cues for deep breathing. The EmWave2 is currently used in clinical care in the inpatient psychiatry units at UNC hospitals.
Before and after each HRVB session, participants will complete three measures of current psychological distress (Spielberger State Anxiety Scale, Linear Analog Self Assessment, Warwick-Edinburgh Mental Well-Being scale). To measure biologic markers of stress, the investigators will collect saliva samples and measure blood pressure before and after administering HRVB. In addition information on the participants' high frequency heart rate variability will also be collected using the Single Channel 3991x Biolog, a research-quality measure of heart rate variability.
Participants will then be instructed to practice their deep breathing exercises for approximately ten minutes each day until the follow-up session and complete a brief log of these exercises. During this period participants will also be asked to complete validated inventories on perceived social support and life experiences (MOS Social Support Scale, Maternal Antenatal Attachment Scale and Adverse Childhood Experiences). At the follow up visit, approximately 5 to 7 days following the baseline session, administration of HRVB inventories on maternal mood, the saliva sample and measurement of high frequency heart rate variability will be repeated. The saliva sample will be used to measure salivary one or all of the following: oxytocin, alpha-amylase, and cortisol.
Finally the investigators will attempt a follow-up call with each participant six to eight weeks following discharge to measure continued use of HRVB techniques and satisfaction qualitative information on HRVB feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variability Biofeedback Tool | Experimental | Behavioral: Heart Rate Variability Biofeedback ToolIntervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- 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 |
|---|---|---|
| Heart Rate Variability Biofeedback ToolAlso: emWave 2 (Heartmath)The Heart Rate Variability Biofeedback tool (emWave 2) will capture heart rate variability (HRV) before and after deep breathing exercises are used among participants. Participants will be able to visualize changes in their HRV and then fill-out self-reported anxiety measures to determine if the breathing exercises and visualization of HRV affected anxiety. | Behavioural | Heart Rate Variability Biofeedback Tool |
Primary outcome
Feasibility of Using HRVB Among Hospitalized Pregnant Women
Time frame: Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)
The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.
5 secondary outcomes
Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).
Time frame: Baseline to in-patient follow-up (5 to 7 days in between)
Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline to in-patient follow-up (5 to 7 days in between)
Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety
Time frame: Baseline to in-patient follow-up (5 to 7 days in between)
Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).
Time frame: Baseline to in-patient follow-up (5 to 7 days in between)
Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).
Time frame: Baseline to in-patient follow-up (5 to 7 days in between)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23179141Beckham AJ, Greene TB, Meltzer-Brody S. A pilot study of heart rate variability biofeedback therapy in the treatment of perinatal depression on a specialized perinatal psychiatry inpatient unit. Arch Womens Ment Health. 2013 Feb;16(1):59-65. doi: 10.1007/s00737-012-0318-7. Epub 2012 Nov 25.
- Results publication: PubMed 18312059Brandon AR, Trivedi MH, Hynan LS, Miltenberger PD, Labat DB, Rifkin JB, Stringer CA. Prenatal depression in women hospitalized for obstetric risk. J Clin Psychiatry. 2008 Apr;69(4):635-43. doi: 10.4088/jcp.v69n0417.
- Results publication: PubMed 1295961MacMullen N, Dulski LA, Pappalardo B. Antepartum vulnerability: stress, coping, and a patient support group. J Perinat Neonatal Nurs. 1992 Dec;6(3):15-25. doi: 10.1097/00005237-199212000-00004. No abstract available.
- Results publication: PubMed 11346045Poehlmann J, Fiese BH. The interaction of maternal and infant vulnerabilities on developing attachment relationships. Dev Psychopathol. 2001 Winter;13(1):1-11. doi: 10.1017/s0954579401001018.
- HRVB descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Samantha Meltzer-Brody, MD, MPH principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability Biofeedback Tool in people with Maternal Stress and Maternal Anxiety, run by University of North Carolina, Chapel Hill 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: stopped early, as of the sponsor's last update on 19 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Using HRVB Among Hospitalized Pregnant Women (time frame: Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119936, which also lists 4 linked publications.
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 19 Mar 2018.