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Breathing your way to recovery: new study tests meditation for ICU stress

NCT ID NCT06867367

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study explores whether easy-to-learn breathing exercises and guided meditations can reduce stress, anxiety, and depression in elderly ICU survivors and their caregivers. Fourteen pairs (survivor and caregiver) will practice Isha Kriya meditation and Nadi Shuddhi breathing for about seven weeks, using a mobile app or group sessions. Researchers will track how often they practice, measure changes in mood and stress through surveys, and record brain activity with a safe, non-invasive EEG cap.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Isha Kriya meditation and Nadi Shuddhi breathing technique
What this could lead to
If it works, this could point toward a simple, low-cost way to support mental health and recovery for ICU survivors and their families.
What could go wrong
This is a very small pilot study with only 14 participants, so results may not apply to everyone. It is designed to test feasibility, not effectiveness, so it may not show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patient Inclusion/Exclusion Criteria Inclusion Criteria: 1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments. 2. Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days. 3. Caregivers who either live in the same household as the survivor or visit more than three times a week. Exclusion Criteria: Co-enrollment in other interventional studies will not be allowed. 1. Age \>=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices) 2. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.) 3. Non-US resident 4. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint). 5. Individuals discharged to a non-home location, such as a rehabilitation center, nursing home, or long-term acute care facility. 6. Individuals with limited internet access, which would prevent access to online guided meditation 7. Prisoners. 8. Individuals who refuse to participate in the study. 9. Not on vasopressor or inotropic support at the time of enrollment. 10. Not on non-invasive ventilation, high-flow nasal cannula (HFNC), or mechanically ventilated. 11. Not on continuous renal replacement therapy (CRRT). 12. Failure to pass Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) screening (\>3.6; Justification: Cognitive decline would limit the ability to engage with and complete the study interventions and assessments). 13. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels. 14. Known diagnosis of moderate or severe dementia. 15. Neurological injury. 16. Residing in a medical institution before admission. 17. Patient on hospice at or before the time of enrollment. 18. Mechanical ventilation at baseline or solely for airway protection. 19. Patient not expected to go home (e.g., transfer to a facility). 20. Patient not expected to survive two months or expected to transition to hospice. 21. Patient died in hospital before enrollment. 22. Attending physician declined enrollment. 23. Patient discharged before being approached for consent. 24. Either the patient or caregiver in the dyad declined participation (based on IQCODE or consent). Caregiver Inclusion/Exclusion Criteria Inclusion Criteria: 1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments. 2. Caregivers who either live in the same household as the survivor or visit more than three times a week. 3. Age ≥18 years old. Exclusion Criteria: 1. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.) 2. Non-US resident 3. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint). 4. Individuals with limited internet access, which would prevent access to online guided meditation 5. Prisoners. 6. Individuals who refuse to participate in the study. 7. Diagnosed with severe psychiatric disorders, such as schizophrenia, bipolar disorder, or ongoing substance abuse, that could interfere with participation. 8. Individuals actively receiving treatment for recent trauma 9. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels. 10. severe or acute medical illness

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Conditions

The condition(s) this trial relates to.

Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.