CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04809519
NCT04809519N/ACompleted

Effect of Integrative Nursing Based Multimodal Interventions on Blood Pressure, Stress and Treatment Compliance Levels in Uncontrolled Hypertensives: Randomized Controlled Trial

Akdeniz University·interventional·Posted Mar 22, 2021·Updated Mar 2, 2022

In Brief

A clinical study evaluating Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives and Ongoing treatment for Uncontrolled Hypertension and 3 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 22, 2021
Enrollment StartOct 6, 2021
Primary CompletionDec 31, 2021
Study CompletionJan 21, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.3 years ago

Interventions

Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensivesother

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.

Ongoing treatmentother

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.