Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives

NCT04809519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives

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.

OTHER

Ongoing treatment

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.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2021-12-31
Completion
2022-01-21

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809519 on ClinicalTrials.gov