NCT00819182

Breathe for Hot Flashes Randomized Controlled Trial

Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Hot Flashes

Interventions

Type	Name	Description
BEHAVIORAL	Paced respiration	Breathing exercise
BEHAVIORAL	Sham comparator: fast shallow breathing	sham breathing exercise

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-06-01
• Completion: 2013-02-01
• First posted: 2009-01-08
• Last updated: 2016-03-24
• Results posted: 2014-02-28

Locations

1 site across 1 country: United States