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Paced Respiration for Vasomotor and Other Menopausal Symptoms: A Randomized, Controlled Trial

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ABSTRACT

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 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), in a Midwestern city and surrounding area.

PARTICIPANTS

Two hundred and eighteen randomized women (96 breast cancer survivors, 122 menopausal women without cancer), recruited through community mailings and registries (29 % minority).

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.

KEY RESULTS

There were no significant group differences for primary outcomes at 8-weeks or 16-weeks post-randomization. Most intervention participants did not achieve 50 % reduction in vasomotor symptoms, despite demonstrated ability to correctly do paced respiration and daily practice. Statistically significant differences in secondary outcomes at 8 and 16 weeks were small, not likely to be clinically relevant, and as likely to favor intervention as breathing control.

CONCLUSIONS

Paced respiration is unlikely to provide clinical benefit for vasomotor or other menopausal symptoms in breast cancer survivors or menopausal women without cancer.

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Acknowledgments

Contributors

There are no additional contributors who meet criteria for authorship.

Funders

The project described was supported by Award Number 5 R01 CA132927 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. The funding agency had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

Prior Presentations

None.

Conflict of Interest

The authors declare that they do not have a conflict of interest.

Author information

Authors and Affiliations

  1. Indiana University, Indianapolis, IN, USA

    Janet S. Carpenter PhD, RN, FAAN, Jingwei Wu MS, Julie L. Otte PhD, RN, Bryan Schneider MD, Kristin Ryker MPH & Eileen Tallman BS

  2. Purdue University, Indianapolis, IN, USA

    Debra S. Burns PhD, MT-BC

  3. University of Wisconsin, Madison, WI, USA

    Menggang Yu PhD

  4. Indiana University School of Nursing, 1111 Middle Drive, NU345, Indianapolis, IN, 46202, USA

    Janet S. Carpenter PhD, RN, FAAN, Julie L. Otte PhD, RN, Kristin Ryker MPH & Eileen Tallman BS

Authors
  1. Janet S. Carpenter PhD, RN, FAAN
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  2. Debra S. Burns PhD, MT-BC
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  3. Jingwei Wu MS
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  4. Julie L. Otte PhD, RN
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  5. Bryan Schneider MD
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  6. Kristin Ryker MPH
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  7. Eileen Tallman BS
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  8. Menggang Yu PhD
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Corresponding author

Correspondence to Janet S. Carpenter PhD, RN, FAAN.

Additional information

Trial registration: http://clinicaltrials.gov, NCT00819182

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplemental Table 3

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Supplemental Figure 2

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Supplemental Figure 3

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Carpenter, J.S., Burns, D.S., Wu, J. et al. Paced Respiration for Vasomotor and Other Menopausal Symptoms: A Randomized, Controlled Trial. J GEN INTERN MED 28, 193–200 (2013). https://doi.org/10.1007/s11606-012-2202-6

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  • DOI: https://doi.org/10.1007/s11606-012-2202-6

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