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NCT03736954 · ClinicalTrials.gov registry record · NA
ICU Doulas Providing Psychological Support
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT03736954: Completed NA study, sponsored by Mayo Clinic.
NCT03736954 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03736954, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback
Primary Outcome
pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.
Interventions
- BEHAVIORAL positive suggestion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the finished NCT03736954 record still lists
NCT03736954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which positive suggestion is the first listed.
NCT03736954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03736954 about?
NCT03736954 is a clinical study titled "ICU Doulas Providing Psychological Support". Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. R...
What is the current status of trial NCT03736954?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2018-11-12. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03736954?
The interventions under investigation include: positive suggestion (BEHAVIORAL).
Who is sponsoring clinical trial NCT03736954?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03736954's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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