Anxiety DisordersDIAL_XNCT05771909
Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers
A study testing NeurodigitX in people with Anxiety Disorders and Hospital Workers, run by Fondation Hôpital Saint-Joseph at 4 sites in France.
Trial summary
The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Hospital Workers, Deep Breath
- What is being tested?
- NeurodigitX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Nov 2023to 31 Dec 2024
- 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
Who may be able to join
- Healthcareworkers whose age ≥ 18 years,
- Healthcareworkers working in the Emergency Department, Intensive Care Unit and/or visiting the Bulle at least once a week (frequency assessed by Delphi method) at Hôpital Paris Saint-Joseph, healthcareworkers visiting the Bulle at Hôpital Marie-Lannelongue at least once a week and healthcareworkers working at Hôpital Sainte-Marie or Hôpital Léopold Bellan
- French speaking staff
- Staff affiliated to the social security system or, failing that, to another health insurance system
- Staff who have given their free, informed and written consent
Who cannot join
- Current participation in another interventional study regarding post-traumatic stress or anxiety
- Regular practice in the last year of deep breathing techniques in the context of anxiety management (meditation, cardiac coherence, etc.)
- Use of medications that slow down the heart rate: antiarrhythmics, calcium channel blockers, beta-blockers.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Marie Lannelongue
Le Plessis-Robinson
Hôpital Léopold BELLAN
Paris, 75014
Hôpital Paris Saint-Joseph
Paris, 75014
Hôpital Sainte-Marie
Paris, 75014
About this study
Official title: Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers: a Randomized Controlled Trial
The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. These international phenomena have also been observed in France.
In addition to the constraints of the general population, health care workers have been, and continue to be, subject to other forms of constraints, linked to their professional activity. Indeed, the risk of viral exposure is for them major, the confrontation with the deaths of patients because of their fragility or the weakness of the care structures, are more violent in connection with their immediate reality. In addition, the workload due to health imperatives has also led to physical and psychological exhaustion of the health care teams. In addition to the international evidence, the existence and severity of the psychological consequences for health care workers have recently been documented at the local level in a survey conducted among the staff of the Groupe hospitalier Paris Saint-Joseph (GhPSJ). In this study of more than 780 people, nearly half of whom were in charge of patients infected with SARS-CoV2, 62% reported increased anxiety since the beginning of the epidemic, 41% had symptoms of anxiety, 21% had symptoms of depression and 14% had signs of post-traumatic stress. Approximately 25% of the total population had chosen to make regular use of the "bulle" (a decompression and care platform made available to staff since the first wave within the establishment) with the aim of reducing the anxiety generated by the situation and particularly by their professional activity. Given the importance of anxiety symptoms detected in healthcare professionals during the COVID-19 pandemic, the use of a simple, brief technique, requiring neither trained personnel nor expensive or difficult-to-access devices, aimed at reducing anxious stress could be of significant benefit to the population, especially to caregivers.
Read more
The objective of this study is to measure the effect of deep breathing on the anxiety of health professionals in the aftermath of the COVID-19 pandemic, and its effect on their quality of life. In order to measure the quality of the sessions, the breathing movements will be performed using a calibrated program and their immediate effectiveness will be evaluated by the variation of the heart rate, visible just after the program by the user.
The NeurodigitX® system offers to control interactive 3D games on a smartphone application through breath via a sensor connected to the phone by Bluetooth. This tool also allows to measure by plethysmography the heart rate variability in a simple and non-invasive way.
This system has been created as a preventive health solution by allowing everyone to measure, compare and share the activity of their Autonomic Nervous System (ANS) to better predict, understand, prevent and treat certain chronic diseases.
- Conditions
- Anxiety Disorders, Hospital Workers, Deep Breath
- Being tested
- NeurodigitX, Control
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurodigitXOther
The "NeurodigitX Group" receiving this program will follow the recommendations for a period of three months (2 sessions of 2 minutes per day).
ControlOther
The "Control Group" does not receive the NeurodigitX application.
| Study group | Role | What they receive |
|---|---|---|
| NeurodigitX | Experimental | After randomization, the "NeurodigitX Group" receiving this program will follow the recommendations for a period of three months (2 sessions of 2 minutes per day).
At this visit and at the 1/2/3 and 6 month visits, staff will complete the following scales and questionnaires (15 minutes in length): Visual Anxiety Analog Scale (VAS), Spielberger Anxiety Scale - State (STAI form Y-A) and SF-12 Quality of Life Questionnaire.
All participants will be called in at 3 months for a visit to measure HRV via the app. Receives: Other: NeurodigitX |
| Control | Other | After randomization, the "Control Group" does not receive the NeurodigitX application.
At this visit and at the 1/2/3 and 6 month visits, staff will complete the following scales and questionnaires (15 minutes in length): Visual Anxiety Analog Scale (VAS), Spielberger Anxiety Scale - State (STAI form Y-A) and SF-12 Quality of Life Questionnaire.
All participants will be called in at 3 months for a visit to measure HRV via the app. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a 3-month program of regular deep breathing practice on anxiety
This outcome corresponds to the comparison of the evolution of anxiety scores between the 2 groups NeuroDigitX and Control, by Spielberger's State-Trait Anxiety Inventory. Each response to a STAI item is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest. For the AE and AT scales, there are 10 and 9 items respectively. To obtain the AE score, the scores obtained on the 20 items corresponding to AE (items 1 to 20) are added together.
Measured: Month 3
Secondary outcomes (5)
Effect of the program on quality of life at 3 month
This outcome corresponds to the comparison of changes in quality of life scores. The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. The SF-12 was created to reduce the burden of response.
Measured: Month 3
Effect of the program on quality of life at 6 month
This outcome corresponds to the comparison of changes in quality of life scores.The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. The SF-12 was created to reduce the burden of response.
Measured: Month 6
Effect of the program on the evolution of heart rate variability at 3 month
This outcome corresponds to the comparison of changes in heart rate variability measurements between the 2 groups at 3 months.
Measured: Month 3
Effect of the program by profession and department (emergency, intensive care, other department)
This outcome corresponds to the comparison of measures of anxiety according to the occupation and service of the volunteers.
Measured: Day 1
Effect of the program by profession and department (emergency, intensive care, other department)
This outcome corresponds to the comparison of measures of anxiety according to the occupation and service of the volunteers. Spielberger's State-Trait Anxiety Inventory: Each response to a STAI item is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest. For the AE and AT scales, there are 10 and 9 items respectively. To obtain the AE score, the scores obtained on the 20 items corresponding to AE (items 1 to 20) are added together.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start30 Nov 2023 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: medical device not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marguerite D'USSEL, MD, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771909
- Sponsor's protocol ID
- DIAL_X
- Acronym
- DIAL_X
- Status last verified
- Aug 2025
- First submitted
- 24 Feb 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casagrande M, Favieri F, Tambelli R, Forte G. The enemy who sealed the world: effects quarantine due to the COVID-19 on sleep quality, anxiety, and psychological distress in the Italian population. Sleep Med. 2020 Nov;75:12-20. doi: 10.1016/j.sleep.2020.05.011. Epub 2020 May 12.
PubMed 32853913Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.
PubMed 32466251Dutheil F, Mondillon L, Navel V. PTSD as the second tsunami of the SARS-Cov-2 pandemic. Psychol Med. 2021 Jul;51(10):1773-1774. doi: 10.1017/S0033291720001336. Epub 2020 Apr 24.
PubMed 32326997Ozamiz-Etxebarria N, Dosil-Santamaria M, Picaza-Gorrochategui M, Idoiaga-Mondragon N. Stress, anxiety, and depression levels in the initial stage of the COVID-19 outbreak in a population sample in the northern Spain. Cad Saude Publica. 2020 Apr 30;36(4):e00054020. doi: 10.1590/0102-311X00054020. eCollection 2020. English, Spanish.
PubMed 32374806Serafini G, Parmigiani B, Amerio A, Aguglia A, Sher L, Amore M. The psychological impact of COVID-19 on the mental health in the general population. QJM. 2020 Jun 22;113(8):531-7. doi: 10.1093/qjmed/hcaa201. Online ahead of print.
PubMed 32569360d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.
PubMed 35482772d'Ussel M, Adam F, Fels A, Chatellier G, Philippart F. Characteristics of Hospital Workers Using a Wellbeing Center Implemented During the COVID-19 Pandemic to Prevent the Emotional Impacts of the Crisis. Front Public Health. 2022 Jul 4;10:913126. doi: 10.3389/fpubh.2022.913126. eCollection 2022.
PubMed 35859769Lefevre H, Stheneur C, Cardin C, Fourcade L, Fourmaux C, Tordjman E, Touati M, Voisard F, Minassian S, Chaste P, Moro MR, Lachal J. The Bulle: Support and Prevention of Psychological Decompensation of Health Care Workers During the Trauma of the COVID-19 Epidemic. J Pain Symptom Manage. 2021 Feb;61(2):416-422. doi: 10.1016/j.jpainsymman.2020.09.023. Epub 2020 Sep 19.
PubMed 32961219
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05771909
- Acronym / sponsor ID
- DIAL_X / DIAL_X
- Conditions
- Anxiety Disorders, Hospital Workers, Deep Breath
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: medical device not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Mar 2023 (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.
The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. These international phenomena have also been observed in France.
In addition to the constraints of the general population, health care workers have been, and continue to be, subject to other forms of constraints, linked to their professional activity. Indeed, the risk of viral exposure is for them major, the confrontation with the deaths of patients because of their fragility or the weakness of the care structures, are more violent in connection with their immediate reality. In addition, the workload due to health imperatives has also led to physical and psychological exhaustion of the health care teams. In addition to the international evidence, the existence and severity of the psychological consequences for health care workers have recently been documented at the local level in a survey conducted among the staff of the Groupe hospitalier Paris Saint-Joseph (GhPSJ). In this study of more than 780 people, nearly half of whom were in charge of patients infected with SARS-CoV2, 62% reported increased anxiety since the beginning of the epidemic, 41% had symptoms of anxiety, 21% had symptoms of depression and 14% had signs of post-traumatic stress. Approximately 25% of the total population had chosen to make regular use of the "bulle" (a decompression and care platform made available to staff since the first wave within the establishment) with the aim of reducing the anxiety generated by the situation and particularly by their professional activity. Given the importance of anxiety symptoms detected in healthcare professionals during the COVID-19 pandemic, the use of a simple, brief technique, requiring neither trained personnel nor expensive or difficult-to-access devices, aimed at reducing anxious stress could be of significant benefit to the population, especially to caregivers.
The objective of this study is to measure the effect of deep breathing on the anxiety of health professionals in the aftermath of the COVID-19 pandemic, and its effect on their quality of life. In order to measure the quality of the sessions, the breathing movements will be performed using a calibrated program and their immediate effectiveness will be evaluated by the variation of the heart rate, visible just after the program by the user.
The NeurodigitX® system offers to control interactive 3D games on a smartphone application through breath via a sensor connected to the phone by Bluetooth. This tool also allows to measure by plethysmography the heart rate variability in a simple and non-invasive way.
This system has been created as a preventive health solution by allowing everyone to measure, compare and share the activity of their Autonomic Nervous System (ANS) to better predict, understand, prevent and treat certain chronic diseases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeurodigitX | Experimental | Other: NeurodigitXAfter randomization, the "NeurodigitX Group" receiving this program will follow the recommendations for a period of three months (2 sessions of 2 minutes per day). At this visit and at the 1/2/3 and 6 month visits, staff will complete the following scales and questionnaires (15 minutes in length): Visual Anxiety Analog Scale (VAS), Spielberger Anxiety Scale - State (STAI form Y-A) and SF-12 Quality of Life Questionnaire. All participants will be called in at 3 months for a visit to measure HRV via the app. |
| Control | Other | Other: ControlAfter randomization, the "Control Group" does not receive the NeurodigitX application. At this visit and at the 1/2/3 and 6 month visits, staff will complete the following scales and questionnaires (15 minutes in length): Visual Anxiety Analog Scale (VAS), Spielberger Anxiety Scale - State (STAI form Y-A) and SF-12 Quality of Life Questionnaire. All participants will be called in at 3 months for a visit to measure HRV via the app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthcareworkers whose age ≥ 18 years,
- Healthcareworkers working in the Emergency Department, Intensive Care Unit and/or visiting the Bulle at least once a week (frequency assessed by Delphi method) at Hôpital Paris Saint-Joseph, healthcareworkers visiting the Bulle at Hôpital Marie-Lannelongue at least once a week and healthcareworkers working at Hôpital Sainte-Marie or Hôpital Léopold Bellan
- French speaking staff
- Staff affiliated to the social security system or, failing that, to another health insurance system
- Staff who have given their free, informed and written consent
Key exclusion criteria (3 listed)
- Current participation in another interventional study regarding post-traumatic stress or anxiety
- Regular practice in the last year of deep breathing techniques in the context of anxiety management (meditation, cardiac coherence, etc.)
- Use of medications that slow down the heart rate: antiarrhythmics, calcium channel blockers, beta-blockers.
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 |
|---|---|---|
| NeurodigitXThe "NeurodigitX Group" receiving this program will follow the recommendations for a period of three months (2 sessions of 2 minutes per day). | Other | NeurodigitX |
| ControlThe "Control Group" does not receive the NeurodigitX application. | Other | Control |
Primary outcome
Effect of a 3-month program of regular deep breathing practice on anxiety
Time frame: Month 3
This outcome corresponds to the comparison of the evolution of anxiety scores between the 2 groups NeuroDigitX and Control, by Spielberger's State-Trait Anxiety Inventory. Each response to a STAI item is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest. For the AE and AT scales, there are 10 and 9 items respectively. To obtain the AE score, the scores obtained on the 20 items corresponding to AE (items 1 to 20) are added together.
5 secondary outcomes
Effect of the program on quality of life at 3 month
Time frame: Month 3
Effect of the program on quality of life at 6 month
Time frame: Month 6
Effect of the program on the evolution of heart rate variability at 3 month
Time frame: Month 3
Effect of the program by profession and department (emergency, intensive care, other department)
Time frame: Day 1
Effect of the program by profession and department (emergency, intensive care, other department)
Time frame: Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 32853913Casagrande M, Favieri F, Tambelli R, Forte G. The enemy who sealed the world: effects quarantine due to the COVID-19 on sleep quality, anxiety, and psychological distress in the Italian population. Sleep Med. 2020 Nov;75:12-20. doi: 10.1016/j.sleep.2020.05.011. Epub 2020 May 12.
- Background: PubMed 32466251Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.
- Background: PubMed 32326997Dutheil F, Mondillon L, Navel V. PTSD as the second tsunami of the SARS-Cov-2 pandemic. Psychol Med. 2021 Jul;51(10):1773-1774. doi: 10.1017/S0033291720001336. Epub 2020 Apr 24.
- Background: PubMed 32374806Ozamiz-Etxebarria N, Dosil-Santamaria M, Picaza-Gorrochategui M, Idoiaga-Mondragon N. Stress, anxiety, and depression levels in the initial stage of the COVID-19 outbreak in a population sample in the northern Spain. Cad Saude Publica. 2020 Apr 30;36(4):e00054020. doi: 10.1590/0102-311X00054020. eCollection 2020. English, Spanish.
- Background: PubMed 32569360Serafini G, Parmigiani B, Amerio A, Aguglia A, Sher L, Amore M. The psychological impact of COVID-19 on the mental health in the general population. QJM. 2020 Jun 22;113(8):531-7. doi: 10.1093/qjmed/hcaa201. Online ahead of print.
- Background: PubMed 35482772d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.
- Background: PubMed 35859769d'Ussel M, Adam F, Fels A, Chatellier G, Philippart F. Characteristics of Hospital Workers Using a Wellbeing Center Implemented During the COVID-19 Pandemic to Prevent the Emotional Impacts of the Crisis. Front Public Health. 2022 Jul 4;10:913126. doi: 10.3389/fpubh.2022.913126. eCollection 2022.
- Background: PubMed 32961219Lefevre H, Stheneur C, Cardin C, Fourcade L, Fourmaux C, Tordjman E, Touati M, Voisard F, Minassian S, Chaste P, Moro MR, Lachal J. The Bulle: Support and Prevention of Psychological Decompensation of Health Care Workers During the Trauma of the COVID-19 Epidemic. J Pain Symptom Manage. 2021 Feb;61(2):416-422. doi: 10.1016/j.jpainsymman.2020.09.023. Epub 2020 Sep 19.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Marguerite D'USSEL, MD study director
Fondation Hôpital Saint-Joseph
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeurodigitX in people with Anxiety Disorders and Hospital Workers, run by Fondation Hôpital Saint-Joseph at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of a 3-month program of regular deep breathing practice on anxiety (time frame: Month 3). 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 NCT05771909, which also lists 8 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 Aug 2025.