Comparison of Heart Rate Variability Biofeedback and Eurythmy Therapy to Reduce Stress in Nurses and Midwives: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Emotional Exhaustion assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent; Female; Working as a nurse or midwife
排除标准
- •Cardiac pacemaker; Severe cardiac arrhythmias (assessed based on medical history)
研究组 & 干预措施
Behavioral - Heart Rate Variability Biofeedback (HRV-BF)
干预措施: HRV Biofeedback (Behavioral)
Behavioral - Eurythmy Therapy (EYT)
干预措施: Behavioral - Eurythmy Therapy (EYT) (Behavioral)
结局指标
主要结局
Change in Emotional Exhaustion assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
时间窗: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
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.
Change in Depersonalization assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
时间窗: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
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.
Change in Personal Accomplishment assessed by the Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
时间窗: Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.
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.
次要结局
- Change in Work Overload assessed by the Trier Inventory for Chronic Stress (TICS)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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(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(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(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(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(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(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(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(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(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(Within 1 week before the start of the intervention and within 1 week after completion of the 6-week intervention.)