Trial Outcomes & Findings for Three Different Programs of Paced Breathing in Treating Hot Flashes in Women (NCT NCT00569166)
NCT ID: NCT00569166
Last Updated: 2017-08-07
Results Overview
Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.
COMPLETED
NA
105 participants
Week 1 and Week 9
2017-08-07
Participant Flow
One-hundred and five (105) participants were recruited at Mayo Clinic Rochester between 3/08/2007 and 12/8/2009. There were 13 cancelled participants and were excluded from baseline characteristics table.
Participants were evaluated by telephone, or in person, according to the eligibility criteria and educated about the requirements of the study. Eligible and willing women were registered onto the study.
Participant milestones
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
31
|
|
Overall Study
COMPLETED
|
21
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
4
|
Reasons for withdrawal
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
Baseline Characteristics
Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Baseline characteristics by cohort
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=30 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=31 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=31 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Age, Customized
Between 18 and 49 years
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Age, Customized
>=50 years
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Breast Cancer History
Yes
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Breast Cancer History
No
|
10 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Average Frequency of Hot Flashes per day
<4 Hot flashes per day
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Average Frequency of Hot Flashes per day
4-9 Hot flashes per day
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Average Frequency of Hot Flashes per day
>=10 Hot flashes per day
|
19 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Current tamoxifen, raloxifene, or aromatase inhibitor treatment
Yes
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Current tamoxifen, raloxifene, or aromatase inhibitor treatment
No
|
16 participants
n=5 Participants
|
24 participants
n=7 Participants
|
19 participants
n=5 Participants
|
59 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 1 and Week 9Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=30 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=31 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=31 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9
|
-6.5 units on a scale
Standard Deviation 5.38
|
-7.5 units on a scale
Standard Deviation 8.14
|
-6.5 units on a scale
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=17 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=22 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=18 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 9 for PSQI Global Score
|
4.8 units on a scale
Interval -14.3 to 28.6
|
4.8 units on a scale
Interval -28.6 to 38.1
|
7.1 units on a scale
Interval -19.0 to 28.6
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who had both baseline and week 9 blood pressure measurements.
Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=19 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=24 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=25 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 9 on Blood Pressure Measurement
Systolic Blood Pressure Evening
|
-0.6 mmHg
Interval -16.2 to 10.6
|
-3.4 mmHg
Interval -14.2 to 14.3
|
2.2 mmHg
Interval -16.6 to 11.7
|
|
Change From Baseline to Week 9 on Blood Pressure Measurement
Diastolic Blood Pressure Morning
|
-4.1 mmHg
Interval -37.0 to 5.7
|
-1.9 mmHg
Interval -23.4 to 10.5
|
-1.6 mmHg
Interval -19.9 to 7.3
|
|
Change From Baseline to Week 9 on Blood Pressure Measurement
Diastolic Blood Pressure Evening
|
-2.1 mmHg
Interval -10.5 to 3.7
|
-1.7 mmHg
Interval -7.6 to 7.5
|
0.5 mmHg
Interval -15.6 to 7.3
|
|
Change From Baseline to Week 9 on Blood Pressure Measurement
Systolic Blood Pressure Morning
|
1.0 mmHg
Interval -14.0 to 9.4
|
0.1 mmHg
Interval -55.2 to 19.6
|
-0.4 mmHg
Interval -14.2 to 17.6
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=18 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=23 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=27 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
POMS Total Score
|
4.4 units on a scale
Standard Deviation 9.2
|
5.2 units on a scale
Standard Deviation 9.9
|
3.9 units on a scale
Standard Deviation 13.1
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Tension-Anxiety Subscale
|
0 units on a scale
Standard Deviation 16.0
|
5 units on a scale
Standard Deviation 13.5
|
3 units on a scale
Standard Deviation 20.7
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Depression-Dejection Subscale
|
1.1 units on a scale
Standard Deviation 9.3
|
3.9 units on a scale
Standard Deviation 13.2
|
-0.6 units on a scale
Standard Deviation 16.6
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Confusion-Bewilderment Subscale
|
5.6 units on a scale
Standard Deviation 11.2
|
5.2 units on a scale
Standard Deviation 9.7
|
0.9 units on a scale
Standard Deviation 8.0
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Fatigue-Inertia Subscale
|
8.6 units on a scale
Standard Deviation 19.0
|
12.4 units on a scale
Standard Deviation 20.1
|
13.8 units on a scale
Standard Deviation 23.3
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Vigor-Activity Subscale
|
8.1 units on a scale
Standard Deviation 17.8
|
4.3 units on a scale
Standard Deviation 21.5
|
4.6 units on a scale
Standard Deviation 17.2
|
|
Change From Baseline to Week 9 for POMS Total Score and Subscales
Anger-Hostility Subscale
|
2.8 units on a scale
Standard Deviation 14.5
|
0.5 units on a scale
Standard Deviation 11.8
|
1.5 units on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=18 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=23 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=25 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
POMS Total Score
|
-0.05 Correlation coefficient
|
-0.32 Correlation coefficient
|
0.29 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Tension-Anxiety Subscale
|
-0.18 Correlation coefficient
|
-0.36 Correlation coefficient
|
0.19 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Depression-Dejection Subscale
|
-0.05 Correlation coefficient
|
-0.35 Correlation coefficient
|
0.35 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Confusion-Bewilderment Subscale
|
0.21 Correlation coefficient
|
-0.33 Correlation coefficient
|
0.37 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Fatigue-Inertia Subscale
|
0.32 Correlation coefficient
|
-0.20 Correlation coefficient
|
0.26 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Vigor-Activity Subscale
|
-0.22 Correlation coefficient
|
0.04 Correlation coefficient
|
0.01 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9
Anger-Hostility Subscale
|
-0.25 Correlation coefficient
|
-0.25 Correlation coefficient
|
0.21 Correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=19 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=23 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=25 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 9 for BFI Fatigue Scores
Fatigue Right Now
|
8.9 units on a scale
Standard Deviation 25.8
|
13.5 units on a scale
Standard Deviation 19.9
|
17.2 units on a scale
Standard Deviation 28.8
|
|
Change From Baseline to Week 9 for BFI Fatigue Scores
Usual Fatigue
|
16.3 units on a scale
Standard Deviation 18.6
|
11.8 units on a scale
Standard Deviation 18.9
|
12.4 units on a scale
Standard Deviation 25.1
|
|
Change From Baseline to Week 9 for BFI Fatigue Scores
Worst Fatigue Last 24 Hours
|
12.6 units on a scale
Standard Deviation 32.8
|
18.7 units on a scale
Standard Deviation 23.2
|
18.8 units on a scale
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=19 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=23 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=23 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9
Fatigue Right Now
|
-0.25 Correlation coefficient
|
-0.20 Correlation coefficient
|
-0.18 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9
Usual Fatigue
|
0.13 Correlation coefficient
|
0.06 Correlation coefficient
|
-0.12 Correlation coefficient
|
|
Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9
Worst Fatigue Last 24 hours
|
0.11 Correlation coefficient
|
-0.36 Correlation coefficient
|
-0.11 Correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=19 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=24 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=27 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 9 for Symptom Distress Diary
Nervousness
|
4.4 units on a scale
Standard Deviation 22.3
|
4.2 units on a scale
Standard Deviation 17.4
|
6.3 units on a scale
Standard Deviation 27.9
|
|
Change From Baseline to Week 9 for Symptom Distress Diary
Fatigue
|
15.3 units on a scale
Standard Deviation 30.3
|
20.8 units on a scale
Standard Deviation 21.0
|
17.2 units on a scale
Standard Deviation 32.2
|
|
Change From Baseline to Week 9 for Symptom Distress Diary
Abnormal Sweating
|
20.0 units on a scale
Standard Deviation 41.8
|
24.6 units on a scale
Standard Deviation 30.2
|
29.2 units on a scale
Standard Deviation 41.1
|
|
Change From Baseline to Week 9 for Symptom Distress Diary
Trouble Sleeping
|
18.3 units on a scale
Standard Deviation 30.2
|
21.7 units on a scale
Standard Deviation 28.2
|
11.9 units on a scale
Standard Deviation 28.0
|
|
Change From Baseline to Week 9 for Symptom Distress Diary
Negative Mood
|
6.1 units on a scale
Standard Deviation 18.5
|
12.1 units on a scale
Standard Deviation 24.0
|
7.8 units on a scale
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: Includes all participants who completed both baseline and week 9 assessments.
Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores.
Outcome measures
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=19 Participants
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=24 Participants
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=25 Participants
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
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Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9
Fatigue
|
-0.24 Correlation coefficient
|
0.04 Correlation coefficient
|
0.26 Correlation coefficient
|
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Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9
Abnormal Sweating
|
-0.43 Correlation coefficient
|
-0.30 Correlation coefficient
|
-0.20 Correlation coefficient
|
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Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9
Trouble Sleeping
|
-0.56 Correlation coefficient
|
-0.15 Correlation coefficient
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-0.28 Correlation coefficient
|
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Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9
Nervousness
|
-0.30 Correlation coefficient
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-0.43 Correlation coefficient
|
0.15 Correlation coefficient
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Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9
Negative Mood
|
-0.19 Correlation coefficient
|
0.05 Correlation coefficient
|
0.21 Correlation coefficient
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Adverse Events
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paced Breathing (15 Min Once Daily, 6 Breaths/Min)
n=30 participants at risk
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)
n=31 participants at risk
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
n=31 participants at risk
Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Number of events 1 • Weekly during week 2 to week 9
|
6.5%
2/31 • Number of events 4 • Weekly during week 2 to week 9
|
3.2%
1/31 • Number of events 1 • Weekly during week 2 to week 9
|
|
General disorders
Influenza Symptoms
|
0.00%
0/30 • Weekly during week 2 to week 9
|
6.5%
2/31 • Number of events 2 • Weekly during week 2 to week 9
|
0.00%
0/31 • Weekly during week 2 to week 9
|
|
Nervous system disorders
Dizziness
|
16.7%
5/30 • Number of events 10 • Weekly during week 2 to week 9
|
12.9%
4/31 • Number of events 4 • Weekly during week 2 to week 9
|
3.2%
1/31 • Number of events 6 • Weekly during week 2 to week 9
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place