Effect of Integrative Nursing Based Multimodal Interventions on Blood Pressure, Stress and Treatment Compliance Levels in Uncontrolled Hypertensives: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
Purpose: The aim of this study is to evaluate the effect of multimodal interventions based on Integrative Nursing (IN) principles on blood pressure, stress, and hypertensive treatment compliance levels in individuals living in the community and with uncontrolled hypertension.
Design: This is a single-center, 1:1 randomized, single-blind, parallel, active comparator trial.
Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. In the study, the group in which Integrative Nursing Principles-Based Multimodal Interventions were applied (UHTINuM) was taken as the experimental (n: 24), the group in which health recommendations were given as the active comparator group (n: 24). The sample size calculated according to the reference study data is 62. However, this target number could not be reached due to the COVID-19 pandemic conditions. This study was carried out with adult individuals aged 50-65 in Hayat Park, which is located within the borders of Konyaaltı District of Antalya province. Multimodal interventions including 12-week meditation and breathing techniques, yoga, hypertension treatment compliance training, and home blood pressure measurement training were applied to the UHTINuM group. The control group was directed to a specialist doctor as an intervention, information notes for hypertensive individuals and standard brochures prepared by the Ministry of Health were given. The primary results of the study were measured using an aneroid and automatic blood pressure device (blood pressure measurement), Hill Bone Hypertension Treatment Adherence Scale, Perceived Stress Scale (PSS).
This will be the first study to evaluate the effect of multimodal interventions based on integrative nursing principles in uncontrolled hypertensives. If the hypotheses of the study are reached, it is expected that the planned intervention protocol will be used by other researchers and thus become widespread in the literature. Also, the results will help contribute to the provision of care in terms of IN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being diagnosed with hypertension and using regular medication for at least 1 year
- •Despite being diagnosed with hypertension, systolic blood pressure 140-159 diastolic blood pressure exceeding 90-99 mmHg
- •Being between the ages of 50-65
- •Not being an obstacle to physical activity
- •Volunteering to participate in research
排除标准
- •The individual is not at a cognitive level to answer the questions asked.
- •Having a mental illness that prevents the individual from participating in the initiative according to his / her own declaration.
- •Stage 2 hypertension (SBP> 160 mm Hg or diastolic blood pressure ≥100 mm Hg)
- •Having a renal problem and cardiovascular disease in which activity is prohibited by the specialist physician according to the statement of the individual.
- •Having practiced yoga once a month in the last 6 months Serious musculoskeletal problems such as spinal stenosis, which, according to the individual's statement, may limit participation in yoga.
- •The individual is using other mind-body therapies such as Qigong, tai chi or meditation.
结局指标
主要结局
Blood Pressure
时间窗: For 12 weeks
Official and self-Blood Pressure Measurements
Perceived Stress Level
时间窗: For 12 weeks
Perceived Stress Scale: A minimum of 0 and a maximum of 32 points are obtained from the scale. Higher total score means higher perceived stress level.
Hypertensive Treatment Compliance
时间窗: Change from Baseline Hypertensive Treatment Compliance at 12 months
Hill-Bone Compliance to High Blood Pressure Therapy Scale: The scale total score varies between 0 and 42 in relation to the number of items. The scores are evaluated for the interpretation of the total, medical, nutrition and interview sub-dimension compliance scores of the scale; If the person gets "0" points in total by giving the most positive answers to all questions, he / she is considered to be fully compatible.
次要结局
- BMI(Change from Baseline BMI at 12 months)
- Physical activity level(Change from Baseline Physical activity level at 12 months)
研究者
Ayse Dagistan Akgoz
Research Assistant
Akdeniz University