Skip to main content
OpenTrials
Completed

NCT Number: NCT04809519

Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uncontrolled Hypertension Behavior Behavior, Health Health Behavior Nurse's Role Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Treatment Compliance

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Social Area (Hayat Park)

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Blood Pressure

    Time frame: For 12 weeks

    Official and self-Blood Pressure Measurements

  2. Perceived Stress Level

    Time frame: For 12 weeks

    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.

  3. Hypertensive Treatment Compliance

    Time frame: Change from Baseline Hypertensive Treatment Compliance at 12 months

    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.

Secondary outcomes

  1. Physical activity level

    Time frame: Change from Baseline Physical activity level at 12 months

    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).

  2. BMI

    Time frame: Change from Baseline BMI at 12 months

    height and weight measurement

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Acronym: UHTINuM

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.