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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHTINuM | Experimental | UHTINuM is an acronym that defines multimodal interventions consisting of three components. These interventions are as follows: (1) Structured yoga program including meditation and breathing techniques (2) Hypertensive Treatment Compliance Training (3) Teaching blood pressure measurement and monitoring at home. |
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| Control group | Active Comparator | Control group will be receive information notes and standard brochures related to physical activity, healthy lifestyle behaviors advice, stop smoking etc. and will be referred to a specialist physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives | Other | In this study, multimodal interventions including yoga, meditation, and breathing techniques, compliance training for hypertension treatment, and home blood pressure measurement training will be applied to the experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Official and self-Blood Pressure Measurements | For 12 weeks |
| Perceived Stress Level | 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. | For 12 weeks |
| Hypertensive Treatment Compliance | 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. | Change from Baseline Hypertensive Treatment Compliance at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity level | International Physical Activity Questionnaire: The short form (seven questions) obtains information about walking, moderate and intense activities, and time spent sitting. The energy required for the activities is calculated by the MET minute score. The score obtained is classified as nonphysical (MET ≤ 600 energy level), insufficient physical activity level (MET = 600-3000 energy level), and sufficient physical activity level (MET ≥3000 energy level). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Social Area (Hayat Park) | Antalya | Konyaaltı | 07070 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41660670 | Derived | Dagistan Akgoz A, Gozum S. Integrative, multimodal nursing intervention for uncontrolled hypertension: randomized controlled trial effects on blood pressure, perceived stress, and medication adherence. Clin Hypertens. 2026 Feb 1;32:e6. doi: 10.5646/ch.2026.32.e6. eCollection 2026. |
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| Ongoing treatment | Other | The ongoing health service of the control group will continue. In addition, the control group will be directed to a specialist doctor and standard brochures prepared by the Ministry of Health for hypertensive individuals will be given. |
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| Change from Baseline Physical activity level at 12 months |
| BMI | height and weight measurement | Change from Baseline BMI at 12 months |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D015438 | Health Behavior |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D001519 | Behavior |
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