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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00819182
The ClinicalTrials.gov registry entry for NCT00819182 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 162-participant average among 23 other Hot Flashes trials with a reported enrollment target (35% higher). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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