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NCT00819182 · ClinicalTrials.gov registry record · NA
Breathe for Hot Flashes Randomized Controlled Trial
A NA study of Hot Flashes, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 218
- Enrollment target
- 1
- Study location
NCT00819182: Completed NA study of Hot Flashes, sponsored by Indiana University.
NCT00819182 is a NA study of Hot Flashes that has completed, run by Indiana University. The registered enrollment target is 218 participants, above the 162-participant average among 23 other Hot Flashes trials with a reported enrollment target (35% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819182, a NA study of Hot Flashes, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 218 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence. Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms. Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area. Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries. Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment. Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.
Primary Outcome
Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.
Conditions Studied
Interventions
- BEHAVIORAL Paced respiration
- BEHAVIORAL Sham comparator: fast shallow breathing
Study Locations (1)
Indiana
- Indiana University School of Nursing - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT00819182 record still lists
NCT00819182 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 23 other Hot Flashes trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Hot Flashes appearing as the primary indexed condition, and to 2 interventions - of which Paced respiration is the first listed.
NCT00819182 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00819182 about?
NCT00819182 is a clinical study titled "Breathe for Hot Flashes Randomized Controlled Trial". Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence. Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other meno...
What is the current status of trial NCT00819182?
This trial is currently completed. It is a NA study. The enrollment target is 218 participants. The study started on 2008-04. Estimated completion is 2013-02.
What conditions does trial NCT00819182 study?
This clinical trial studies the following conditions: Hot Flashes.
What interventions are being tested in trial NCT00819182?
The interventions under investigation include: Paced respiration (BEHAVIORAL), Sham comparator: fast shallow breathing (BEHAVIORAL).
Who is sponsoring clinical trial NCT00819182?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00819182 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hot Flashes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00819182's enrollment target sits among peer trials
218 5th of 23 higher than 19 of 23 other Hot Flashes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hot Flashes 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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