NCT04809519: UHTINuM

Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives

Completed NA Last updated 2 March 2022

What this trial tests

NA trial testing Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives in Uncontrolled Hypertension in 48 participants. Completed in 21 January 2022.

Timeline

6 October 2021

Primary endpoint
31 December 2021

21 January 2022

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	48
Start date	6 October 2021
Primary completion	31 December 2021
Estimated completion	21 January 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives
• Ongoing treatment

Conditions studied

• Uncontrolled Hypertension — all drugs for Uncontrolled Hypertension →
• Treatment Compliance — all drugs for Treatment Compliance →
• Behavior, Health — all drugs for Behavior, Health →
• Nurse's Role — all drugs for Nurse's Role →

Sponsor

Akdeniz University

Who can join

Adults 50 to 65, any sex, with Uncontrolled Hypertension or Treatment Compliance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integrative, multimodal nursing intervention for uncontrolled hypertension: randomized controlled trial effects on blood pressure, perceived stress, and medication adherence.
   Dağıstan Akgöz A, Gözüm S. · · 2026 · PMID 41660670 · DOI 10.5646/ch.2026.32.e6