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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
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.
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.
ARCIM Institute
Filderstadt, Baden-Wurttemberg, Germany
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
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