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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
What is being tested?
HRV Biofeedback and Behavioral - Eurythmy Therapy (EYT)
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.

Germany1 site
  • ARCIM Institute

    Filderstadt, Baden-Wurttemberg, 70794

Other trials in Germany

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 groups in NCT07827092
Study groupRoleWhat they receive
Behavioral - Heart Rate Variability Biofeedback (HRV-BF)ExperimentalNot described
Receives: Behavioral: HRV Biofeedback
Behavioral - Eurythmy Therapy (EYT)ExperimentalNot described
Receives: Behavioral: Behavioral - Eurythmy Therapy (EYT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  3. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  1. First posted18 Sep 2026
  2. Study start16 Jan 2012
  3. Primary completion20 Jan 2012
  4. Study completion9 Mar 2012

Resources

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)
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.

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