Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives

NCT04809519 | Completed

• 1 other identifier: 0030
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Uncontrolled Hypertension; Treatment Compliance; Behavior, Health; Nurse's Role

Keywords

Uncontrolled Hypertension; Treatment Adherence and Compliance; Integrative Medicine; Holistic Nursing; Yoga; Meditation; Breathing Exercises; Blood Pressure; Blood Pressure Monitoring, Home; Blood Pressure Monitoring, Self

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Physical activity level

  Change from Baseline Physical activity level at 12 months

• BMI

  Change from Baseline BMI at 12 months

Study Arms (2)

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.

Other: Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives

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.

Other: Ongoing treatment

Interventions

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.

UHTINuM

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.

Control group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Community Social Area (Hayat Park)

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance; Health Behavior; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: October 6, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 21, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

TU (1)