Comparison of HRV Biofeedback and Eurythmy Therapy as Stress Management Interventions for Female Nurses and MidwivesNCT07827092
Stress Management Among Nurses and Midwives in Inpatient Care
A study testing HRV Biofeedback and Behavioral - Eurythmy Therapy (EYT) in people with Comparison of HRV Biofeedback and Eurythmy Therapy as Stress Management Interventions for Female Nurses and Midwives, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
This study compares two six-week stress-management programs for female nurses and midwives working in a hospital: heart rate variability biofeedback and Eurythmy Therapy. Participants will be randomly assigned to one of the two programs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparison of HRV Biofeedback and Eurythmy Therapy as Stress Management Interventions for Female Nurses and Midwives
- What is being tested?
- HRV Biofeedback and Behavioral - Eurythmy Therapy (EYT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2012to 9 Mar 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent; Female; Working as a nurse or midwife
Who cannot join
- Cardiac pacemaker; Severe cardiac arrhythmias (assessed based on medical history)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Heart Rate Variability Biofeedback and Eurythmy Therapy to Reduce Stress in Nurses and Midwives: A Randomized Controlled Trial
This study compares two six-week stress-management programs for female nurses and midwives working in a hospital: heart rate variability biofeedback and Eurythmy Therapy. Participants will be randomly assigned to one of the two programs. Before and after the program, questionnaires and heart rate variability measurements will be used to assess changes in burnout, stress, depression, sleep quality, quality of life, and the body's ability to regulate stress.
Read the detailed description
This randomized, active-controlled, parallel-group study investigates the effects of two six-week stress-management interventions-heart rate variability biofeedback (HRV-BF) and Eurythmy Therapy (EYT)-in female nurses and midwives working in a hospital setting. Participants will be randomly assigned to one of the two intervention groups. Assessments will be conducted before and after the intervention using questionnaires and heart rate variability (HRV) measurements. The primary outcomes are the three subscales of the Maslach Burnout Inventory (MBI): Emotional Exhaustion, Depersonalization, and Reduced Personal Accomplishment. Secondary outcomes include the nine scales of the Trier Inventory for Chronic Stress (TICS), the SF-12 score, the global score of the Pittsburgh Sleep Quality Index (PSQI), the total score of the General Depression Scale (ADS; German version of the CES-D), time- and frequency-domain parameters derived from a 10-minute resting HRV measurement, and time-domain parameters derived from a 2-minute breathing test. The study follows a mixed factorial 2 × 2 design, with intervention group as the between-subject factor and time point as the within-subject factor. The primary focus is on whether changes over time differ between the two intervention groups.
- Being tested
- HRV Biofeedback, Behavioral - Eurythmy Therapy (EYT)
- Keywords
- Occupational stress, Burnout, Nurses, Midwives, Heart rate variability, HRV biofeedback, Eurythmy Therapy, Stress management, Sleep quality, Quality of life
- Medical subject headings
- Occupational Stress, Burnout, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV BiofeedbackBehavioural
Participants will receive a six-week heart rate variability biofeedback (HRV-BF) intervention using the Qiu device. The first two training sessions will take place at the study center under the supervision of a trained professional and will last approximately 30-45 minutes each. Subsequently, participants will perform 15 minutes of HRV biofeedback training independently at home each day. Supervised booster sessions will be conducted at the study center after 7, 21, and 35 days, each lasting approximately 20-30 minutes. The total intervention period will be six weeks.
Behavioral - Eurythmy Therapy (EYT)Behavioural
Participants will receive a six-week Eurythmy Therapy (EYT) intervention. The first two exercise sessions will take place at the study center under the supervision of a qualified Eurythmy Therapist and will last approximately 30-45 minutes each. Subsequently, participants will independently practice the learned Eurythmy Therapy exercises at home for 15 minutes each day. Supervised booster sessions will be conducted at the study center after 7, 21, and 35 days, each lasting approximately 20-30 minutes. The total intervention period will be six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral - Heart Rate Variability Biofeedback (HRV-BF) | Experimental | Not described Receives: Behavioral: HRV Biofeedback |
| Behavioral - Eurythmy Therapy (EYT) | Experimental | Not described Receives: Behavioral: Behavioral - Eurythmy Therapy (EYT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Exhaustion assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Emotional Exhaustion is assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory - Human Services Survey (MBI-HSS). The MBI-HSS is a 22-item self-report questionnaire comprising three subscales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. The Emotional Exhaustion subscale consists of 9 items rated on a 7-point frequency scale from 0 (never) to 6 (every day), resulting in a score ranging from 0 to 54. Higher scores indicate greater emotional exhaustion.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Depersonalization assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Depersonalization is assessed using the Depersonalization subscale of the Maslach Burnout Inventory - Human Services Survey (MBI-HSS). The subscale consists of 5 items rated on a 7-point frequency scale from 0 (never) to 6 (every day), resulting in a score ranging from 0 to 30. Higher scores indicate greater depersonalization.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Personal Accomplishment assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Personal Accomplishment is assessed using the Personal Accomplishment subscale of the Maslach Burnout Inventory - Human Services Survey (MBI-HSS). The subscale consists of 8 items rated on a 7-point frequency scale from 0 (never) to 6 (every day), resulting in a score ranging from 0 to 48. Higher scores indicate greater personal accomplishment and therefore lower burnout.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Secondary outcomes (23)
Change in Work Overload assessed by the Trier Inventory for Chronic Stress (TICS)
Work Overload is assessed using the corresponding subscale of the Trier Inventory for Chronic Stress (TICS). The TICS is a 57-item self-report questionnaire assessing chronic stress across nine domains. Items are rated on a 5-point frequency scale from 0 (never) to 4 (very often/always) with reference to experiences during the previous three months. Higher subscale scores indicate greater chronic stress in the respective domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Social Overload assessed by the Trier Inventory for Chronic Stress (TICS)
Social Overload is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Pressure to Perform assessed by the Trier Inventory for Chronic Stress (TICS)
Pressure to Perform is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Work Discontent assessed by the Trier Inventory for Chronic Stress (TICS)
Work Discontent is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Excessive Demands at Work assessed by the Trier Inventory for Chronic Stress (TICS)
Excessive Demands at Work are assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Lack of Social Recognition assessed by the Trier Inventory for Chronic Stress (TICS)
Lack of Social Recognition is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Social Tensions assessed by the Trier Inventory for Chronic Stress (TICS)
Social Tensions are assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Social Isolation assessed by the Trier Inventory for Chronic Stress (TICS)
Social Isolation is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Chronic Worrying assessed by the Trier Inventory for Chronic Stress (TICS)
Chronic Worrying is assessed using the corresponding subscale of the TICS. Higher subscale scores indicate greater chronic stress in this domain.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Physical Component Summary Score assessed by the 12-Item Short Form Health Survey (SF-12)
Physical health-related quality of life is assessed using the Physical Component Summary (PCS-12) of the 12-Item Short Form Health Survey (SF-12). The SF-12 is a 12-item self-report measure of health-related quality of life. The PCS-12 is calculated according to the standardized SF-12 scoring algorithm, with higher scores indicating better physical health-related quality of life.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Mental Component Summary Score assessed by the 12-Item Short Form Health Survey (SF-12)
Mental health-related quality of life is assessed using the Mental Component Summary (MCS-12) of the 12-Item Short Form Health Survey (SF-12). The MCS-12 is calculated according to the standardized SF-12 scoring algorithm, with higher scores indicating better mental health-related quality of life.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Global Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality is assessed using the global score of the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and sleep disturbances over the previous month across seven components. The seven component scores are summed to obtain a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Depressive Symptoms assessed by the German version (ADS, Allgemeine Depressionsskala) of the Center for Epidemiologic Studies Depression Scale (CES-D)
Depressive symptoms are assessed using the German version (ADS, Allgemeine Depressionsskala) of the Center for Epidemiologic Studies Depression Scale (CES-D). The 20-item self-report questionnaire assesses the frequency of depressive symptoms during the previous week. Items are rated on a 4-point scale, resulting in a total score ranging from 0 to 60. Higher scores indicate greater depressive symptom severity.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Root Mean Square of Successive Differences (RMSSD) During Resting Heart Rate Variability Measurement
Heart rate variability is assessed during a 10-minute resting measurement. The root mean square of successive differences (RMSSD) is calculated from successive normal-to-normal (NN) interbeat intervals and is reported in milliseconds (ms). RMSSD reflects short-term beat-to-beat heart rate variability.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN) During Resting Heart Rate Variability Measurement
Heart rate variability is assessed during a 10-minute resting measurement. The standard deviation of normal-to-normal intervals (SDNN) is calculated as the standard deviation of all normal-to-normal (NN) interbeat intervals during the analyzed recording and is reported in milliseconds (ms).
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Natural Log-Transformed High-Frequency Power [ln(HF Power)] During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. Absolute high-frequency (HF) power represents spectral power within the HF band of 0.15 to 0.40 Hz and is initially calculated in milliseconds squared (ms²). HF power is natural log-transformed [ln(HF Power)] for statistical analysis. Change is calculated as the post-intervention ln(HF Power) value minus the pre-intervention ln(HF Power) value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in the Natural Log-Transformed Low-Frequency to High-Frequency Power Ratio [ln(LF/HF Ratio)] During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. The LF/HF ratio is calculated by dividing absolute low-frequency power by absolute high-frequency power. LF power is determined within the frequency band of 0.04 to 0.15 Hz, and HF power within the frequency band of 0.15 to 0.40 Hz. The LF/HF ratio is dimensionless and is natural log-transformed for statistical analysis. Change is calculated as the post-intervention ln(LF/HF ratio) value minus the pre-intervention ln(LF/HF ratio) value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Relative High-Frequency Power During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. Relative high-frequency (HF) power represents the proportion of total spectral power occurring within the HF band of 0.15 to 0.40 Hz. It is calculated as HF power divided by total power and multiplied by 100 and is reported as a percentage (%). Change is calculated as the post-intervention value minus the pre-intervention value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Relative Low-Frequency Power During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. Relative low-frequency (LF) power represents the proportion of total spectral power occurring within the LF band of 0.04 to 0.15 Hz. It is calculated as LF power divided by total power and multiplied by 100 and is reported as a percentage (%). Change is calculated as the post-intervention value minus the pre-intervention value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Absolute Low-Frequency Power During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. Absolute low-frequency (LF) power represents spectral power within the LF band of 0.04 to 0.15 Hz and is reported in milliseconds squared (ms²). Change is calculated as the post-intervention value minus the pre-intervention value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Total Power During Resting Heart Rate Variability Measurement
Frequency-domain heart rate variability is assessed during a 10-minute resting measurement. Total power represents the overall spectral power of normal-to-normal (NN) interval variability across the prespecified analyzed frequency range. It is calculated as the sum of the spectral power in the very-low-frequency, low-frequency, and high-frequency bands and is reported in milliseconds squared (ms²). Change is calculated as the post-intervention value minus the pre-intervention value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in the Percentage of Successive Normal-to-Normal Intervals Differing by More Than 50 Milliseconds (pNN50) During Resting Heart Rate Variability Measurement
Heart rate variability is assessed during a 10-minute resting measurement. pNN50 is calculated as the number of pairs of successive normal-to-normal (NN) interbeat intervals that differ by more than 50 milliseconds, divided by the total number of successive NN interval pairs and multiplied by 100. The parameter is reported as a percentage (%). Change is calculated as the post-intervention value minus the pre-intervention value.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Change in Normalized Respiratory Sinus Arrhythmia (RSAnorm) During Resting Heart Rate Variability Measurement
Cardiac autonomic regulation during controlled breathing is assessed using a 2-minute breathing test. Normalized respiratory sinus arrhythmia (RSAnorm) is derived from heart rate variability during the breathing test according to the prespecified analysis procedure. Higher values indicate a greater respiratory modulation of heart rate.
Measured: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start16 Jan 2012
- Primary completion20 Jan 2012
- Study completion9 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of HRV Biofeedback and Eurythmy Therapy as Stress Management Interventions for Female Nurses and MidwivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Die Filderklinik, Filderstadt, Germany, University of Wuerzburg
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Professor, Study director, ARCIM Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827092
- Sponsor's protocol ID
- STM_01
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available.