Clinical trial NCT04809519: Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives
Official title: Effect of Integrative Nursing Based Multimodal Interventions on Blood Pressure, Stress and Treatment Compliance Levels in Uncontrolled Hypertensives: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Treatment Compliance
Behavior, Health
Nurse's Role
Keywords: Uncontrolled Hypertension
Treatment Adherence and Compliance
Integrative Medicine
Holistic Nursing
Yoga
Meditation
Breathing Exercises
Blood Pressure
Blood Pressure Monitoring, Home
Blood Pressure Monitoring, Self
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* BMI\> 40
* 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: For 12 weeks
measure: Perceived Stress Level
timeFrame: For 12 weeks
measure: Hypertensive Treatment Compliance
timeFrame: Change from Baseline Hypertensive Treatment Compliance at 12 months
Secondary outcomes:
measure: Physical activity level
timeFrame: Change from Baseline Physical activity level at 12 months
measure: BMI
timeFrame: Change from Baseline BMI at 12 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Community Social Area (Hayat Park)
state: Konyaaltı
Study officials:
References: