Trial Outcomes & Findings for The Effects of Emotional Exposure on State Anxiety (NCT NCT03458702)
NCT ID: NCT03458702
Last Updated: 2019-11-25
Results Overview
State anxiety (STAI-Y1 score) at baseline ( 10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after completion of 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)) was measured by Spielberger's 20 question State Anxiety Questionnaire (STAI-YI). Scores range from 20-80, with higher scores indicative of increased state anxiety.
COMPLETED
NA
56 participants
10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli
2019-11-25
Participant Flow
We recruited women from yoga classes at the university.
Qualified participants were asked to track their menstrual cycle using a menstrual log and e-mail the primary investigator on day 1 of the follicular phase of their menstrual cycle. The participant was then scheduled for condition A first or condition B first.
Participant milestones
| Measure |
YogaFit Then Quit Rest
Participants completed a 30 min YogaFit Session and then a 30 min Quiet Rest Session on different days.
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
On another day, participants completed 30 min of Quiet Rest
|
Quiet Rest Then Yoga Fit
Participants completed 30 min of Quiet Rest and then 30 min of YogaFit on different days.
|
|---|---|---|
|
Study Condition A (Yoga or Rest)
STARTED
|
28
|
28
|
|
Study Condition A (Yoga or Rest)
COMPLETED
|
24
|
22
|
|
Study Condition A (Yoga or Rest)
NOT COMPLETED
|
4
|
6
|
|
Study Condition B (Yoga or Rest)
STARTED
|
24
|
22
|
|
Study Condition B (Yoga or Rest)
COMPLETED
|
20
|
20
|
|
Study Condition B (Yoga or Rest)
NOT COMPLETED
|
4
|
2
|
|
Picture Rating/Body Composition
STARTED
|
20
|
20
|
|
Picture Rating/Body Composition
COMPLETED
|
20
|
20
|
|
Picture Rating/Body Composition
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
YogaFit Then Quit Rest
Participants completed a 30 min YogaFit Session and then a 30 min Quiet Rest Session on different days.
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
On another day, participants completed 30 min of Quiet Rest
|
Quiet Rest Then Yoga Fit
Participants completed 30 min of Quiet Rest and then 30 min of YogaFit on different days.
|
|---|---|---|
|
Study Condition A (Yoga or Rest)
Lost to Follow-up
|
4
|
6
|
|
Study Condition B (Yoga or Rest)
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
The Effects of Emotional Exposure on State Anxiety
Baseline characteristics by cohort
| Measure |
YogaFit and Quit Rest
n=40 Participants
Participants completed 30 min of YogaFit and then 30 min of Quiet Rest on different days.
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
STAI-Y2 score
|
39.05 units on a scale
STANDARD_DEVIATION 5.91 • n=5 Participants
|
|
Beck Depression Inventory
|
7.68 units on a scale
STANDARD_DEVIATION 4.21 • n=5 Participants
|
|
Body Mass Index (BMI)
|
23.21 kg/m^2
STANDARD_DEVIATION 3.12 • n=5 Participants
|
|
Body Fat Percentage
|
34.94 percentage
STANDARD_DEVIATION 7.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuliState anxiety (STAI-Y1 score) at baseline ( 10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after completion of 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)) was measured by Spielberger's 20 question State Anxiety Questionnaire (STAI-YI). Scores range from 20-80, with higher scores indicative of increased state anxiety.
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure
Baseline
|
33.48 score on a scale
Standard Deviation 9.41
|
33.53 score on a scale
Standard Deviation 10.63
|
|
STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure
Post-Condition
|
27.43 score on a scale
Standard Deviation 7.05
|
29.78 score on a scale
Standard Deviation 7.82
|
|
STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure
Post-Exposure
|
33.18 score on a scale
Standard Deviation 10.75
|
34.48 score on a scale
Standard Deviation 10.34
|
PRIMARY outcome
Timeframe: 10 min prior to condition, 30 min during condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuliHR in beats per min assessed utilizing three electrodes and ProComp Infiniti Software at baseline (10 min prior to condition), during the condition (30 min of YogaFit and Quiet Rest), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)).
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure
Baseline
|
72.48 beats per minute
Standard Deviation 10.61
|
73.59 beats per minute
Standard Deviation 11.25
|
|
Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure
During Condition
|
101.01 beats per minute
Standard Deviation 22.65
|
69.35 beats per minute
Standard Deviation 10.61
|
|
Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure
Post-Condition
|
74.51 beats per minute
Standard Deviation 10.39
|
70.43 beats per minute
Standard Deviation 9.77
|
|
Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure
Post-Exposure
|
71.69 beats per minute
Standard Deviation 9.73
|
70.17 beats per minute
Standard Deviation 9.65
|
PRIMARY outcome
Timeframe: 10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuliA measure of HRV, RMSSD, was assessed using three electrodes and CardioPro Infiniti-HRV Analysis Software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). HRV is associated with good health: increased RMSSD is thought to be beneficial.
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure
Baseline
|
61.32 milliseconds
Standard Deviation 30.80
|
61.87 milliseconds
Standard Deviation 33.98
|
|
Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Condition
|
62.41 milliseconds
Standard Deviation 36.33
|
75.66 milliseconds
Standard Deviation 40.67
|
|
Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Exposure
|
72.75 milliseconds
Standard Deviation 43.11
|
79.41 milliseconds
Standard Deviation 42.49
|
PRIMARY outcome
Timeframe: 10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuliA measure of HRV, LFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units. The formula for n.u. for LF = LF in ms2/LF in ms2 + LF in ms2 HRV is associated with good health: increased LFNU is thought to be beneficial.
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Baseline
|
53.50 ratio
Standard Deviation 17.13
|
53.75 ratio
Standard Deviation 17.93
|
|
Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Condition
|
52.56 ratio
Standard Deviation 16.07
|
54.50 ratio
Standard Deviation 17.77
|
|
Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Exposure
|
58.42 ratio
Standard Deviation 13.86
|
56.52 ratio
Standard Deviation 15.18
|
PRIMARY outcome
Timeframe: 10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuliA measure of HRV, HFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units. The formula for n.u. for HF = HF in ms2/LF in ms2 + LF in ms2. HRV is associated with good health: HFNU and LFNU are negatively correlated.
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Baseline
|
46.49 ratio
Standard Deviation 17.13
|
46.25 ratio
Standard Deviation 17.93
|
|
High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Condition
|
47.19 ratio
Standard Deviation 16.22
|
44.55 ratio
Standard Deviation 17.89
|
|
High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure
Post-Exposure
|
41.58 ratio
Standard Deviation 13.86
|
43.55 ratio
Standard Deviation 15.15
|
SECONDARY outcome
Timeframe: Post-Condition, 10 min after completion of YogaFit and Quiet RestRatings of perceived exertion (RPE) assessed using Borg's scale of perceived exertion and pain. Scores range from 6-20, with 6 indicating no exertion at all.
Outcome measures
| Measure |
YogaFit
n=40 Participants
YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)\], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
|
Quiet Rest
n=40 Participants
30 min of Quiet Rest
|
|---|---|---|
|
RPE Assessed Post-Condition
|
10.83 score on a scale
Standard Deviation 1.66
|
6.05 score on a scale
Standard Deviation 0.22
|
Adverse Events
YogaFit
Quiet Rest
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place