Trial Outcomes & Findings for Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS) (NCT NCT05961995)
NCT ID: NCT05961995
Last Updated: 2025-02-14
Results Overview
The primary outcomes were state and trait anxiety and mood states, measured using the State-Trait-Anxiety Inventory (STAI) and Profile of Mood States (POMS) respectively. The STAI-S evaluates current feelings of apprehension, tension, nervousness, and worry. The scale consists of two 20-item subscales and four rating categories including very much so, moderately so, somewhat and not at all. Scores for STAI range from 20 to 80. Higher scores indicate great anxiety, lower scores indicate no or low anxiety. The POMS is a 35-item validated questionnaire that assesses mood states of tension, depression, anger, vigor, fatigue and confusion. There is a variation in the range of scores for each subscale, with the lowest being 0 and the highest 60. A lower score indicates a better mood, and vice versa. Total score is calculated by summing the totals for the negative subscales and then subtracting the totals for the positive subscales with a higher score indicating worse mood disturbance.
COMPLETED
NA
45 participants
6 weeks
2025-02-14
Participant Flow
Participant milestones
| Measure |
HFN Meditation
Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.
Heartfulness meditation: Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
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|---|---|
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Overall Study
STARTED
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45
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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15
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS)
Baseline characteristics by cohort
| Measure |
HFN Meditation
n=30 Participants
Patients aged 18-80 years diagnosed with cyclic vomiting syndrome based on Rome criteria who meet the eligibility criteria were assigned for the 6 week heartfulness meditation sessions.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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29 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Age, Continuous
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39 years
STANDARD_DEVIATION 14.8 • n=5 Participants
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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23 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 weeksPopulation: Patients aged 18-80 years diagnosed with CVS who meet the Rome criteria
The primary outcomes were state and trait anxiety and mood states, measured using the State-Trait-Anxiety Inventory (STAI) and Profile of Mood States (POMS) respectively. The STAI-S evaluates current feelings of apprehension, tension, nervousness, and worry. The scale consists of two 20-item subscales and four rating categories including very much so, moderately so, somewhat and not at all. Scores for STAI range from 20 to 80. Higher scores indicate great anxiety, lower scores indicate no or low anxiety. The POMS is a 35-item validated questionnaire that assesses mood states of tension, depression, anger, vigor, fatigue and confusion. There is a variation in the range of scores for each subscale, with the lowest being 0 and the highest 60. A lower score indicates a better mood, and vice versa. Total score is calculated by summing the totals for the negative subscales and then subtracting the totals for the positive subscales with a higher score indicating worse mood disturbance.
Outcome measures
| Measure |
HFN Meditation
n=30 Participants
Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.
Heartfulness meditation: Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
|
|---|---|
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Baseline (week 1) State anxiety
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34.59 score on a scale
Standard Deviation 10.48
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Week 3 State anxiety
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35.05 score on a scale
Standard Deviation 10.19
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
week 6 State anxiety
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26.27 score on a scale
Standard Deviation 6.95
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
baseline (Week 1) Trait Anxiety
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41.67 score on a scale
Standard Deviation 15.02
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Week 3 Trait Anxiety
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39.76 score on a scale
Standard Deviation 11.98
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
week 6 Trait Anxiety
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36.10 score on a scale
Standard Deviation 11.73
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Baseline (week 1) POMS
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54.46 score on a scale
Standard Deviation 14.44
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Week 3 POMS
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48.75 score on a scale
Standard Deviation 9.28
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State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
Week 6 POMS
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46.43 score on a scale
Standard Deviation 9.67
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SECONDARY outcome
Timeframe: 6 weeksBSI-GSI scores are converted to area t-scores, with a mean of 50 and a standard deviation of 10. A higher t-score indicates greater psychological distress, whereas a lower t-score indicates less psychological distress. PROMIS scores in the clinical sample are reported as T-scores, with a mean of 50 and a standard deviation of 10. Higher T-scores for PROMIS Mental and PROMIS Physical indicate better mental and physical health respectively. PSQI sleep quality scores have a total minimum and maximum score of 0 and 21. A score of 0-5 is considered a good quality of sleep, whereas 6- 21 is considered a poor quality of sleep. COPE for religion and spirituality minimum score of 2 indicates no or limited use of spirituality or religion as a coping tool, whereas a maximum score of 8 indicates greater reliance on spirituality or religion as a coping strategy. VAS ranges from 0 to 10, a higher and lower VAS score indicates an increased and decreased perceived effectiveness respectively.
Outcome measures
| Measure |
HFN Meditation
n=30 Participants
Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.
Heartfulness meditation: Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
|
|---|---|
|
Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
BSI GSI WEEK 3
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55.68 score on a scale
Standard Deviation 9.68
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
BSI GSI WEEK 6
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54.21 score on a scale
Standard Deviation 9.56
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS Baseline-Mental
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46.63 score on a scale
Standard Deviation 9.44
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS week 6-Mental
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49.87 score on a scale
Standard Deviation 8.33
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
Sleep quality (PSQI)-Baseline
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1.21 score on a scale
Standard Deviation 0.73
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
BSI GSI BASELINE
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57.86 score on a scale
Standard Deviation 10.59
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS week 3-Mental
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46.89 score on a scale
Standard Deviation 7.81
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS Baseline-Physical
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46.61 score on a scale
Standard Deviation 9.37
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS week 3-Physical
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48.2 score on a scale
Standard Deviation 9.81
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
PROMIS week 6-Physical
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49.76 score on a scale
Standard Deviation 8.29
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
Sleep quality (PSQI)-Week 3
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0.96 score on a scale
Standard Deviation 0.88
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
Sleep quality (PSQI)-Week 6
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0.71 score on a scale
Standard Deviation 0.76
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
COPE- Religion/spirituality -Baseline
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3.76 score on a scale
Standard Deviation 2.02
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
COPE- Religion/spirituality-Week 3
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5.07 score on a scale
Standard Deviation 1.77
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
COPE - Religion/spirituality- Week 6
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5.31 score on a scale
Standard Deviation 1.56
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
VAS effectiveness score - baseline
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6.40 score on a scale
Standard Deviation 1.50
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Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
VAS effectiveness score - Week 6
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6.40 score on a scale
Standard Deviation 1.83
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Adverse Events
Single Arm Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thangam Venkatesan
The Ohio State University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place