Uncontrolled HypertensionUHTINuMNCT04809519
Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives
A study testing Ongoing treatment in people with Uncontrolled Hypertension and Treatment Compliance, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Hypertension, Treatment Compliance, Behavior, Health
- What is being tested?
- Ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2021to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Community Social Area (Hayat Park)
Antalya, Konyaaltı, 07070
About this study
Official title: Effect of Integrative Nursing Based Multimodal Interventions on Blood Pressure, Stress and Treatment Compliance Levels in Uncontrolled Hypertensives: Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives, Ongoing treatment
- 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
- Medical subject headings
- Patient Compliance, Health Behavior, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ongoing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Official and self-Blood Pressure Measurements
Measured: 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.
Measured: 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.
Measured: Change from Baseline Hypertensive Treatment Compliance at 12 months
Secondary outcomes (2)
Physical activity level
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).
Measured: Change from Baseline Physical activity level at 12 months
BMI
height and weight measurement
Measured: Change from Baseline BMI at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Oct 2021
- Primary completion31 Dec 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Dagistan Akgoz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809519
- Sponsor's protocol ID
- 0030
- Acronym
- UHTINuM
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dagistan Akgoz A, Gozum S. Integrative, multimodal nursing intervention for uncontrolled hypertension: randomized controlled trial effects on blood pressure, perceived stress, and medication adherence. Clin Hypertens. 2026 Feb 1;32:e6. doi: 10.5646/ch.2026.32.e6. eCollection 2026.
PubMed 41660670
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrative Nursing Based Multimodal Interventions on Blood Pressure, Stress and Treatment Compliance Levels in Uncontrolled Hypertensives: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04809519
- Acronym / sponsor ID
- UHTINuM / 0030
- Keywords
- Uncontrolled Hypertension, Treatment Adherence and Compliance, Integrative Medicine, Holistic Nursing, Yoga, Meditation, Breathing Exercises, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHTINuM | Experimental | Other: Integrative Nursing based Multimodal Interventions for Uncontrolled HypertensivesUHTINuM 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. |
| Control group | Active comparator | Other: Ongoing treatmentControl 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Nursing based Multimodal Interventions for Uncontrolled HypertensivesIn 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 | UHTINuM |
| Ongoing treatmentThe 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. | Other | Control group |
Primary outcome
Blood Pressure
Time frame: For 12 weeks
Official and self-Blood Pressure Measurements
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.
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.
2 secondary outcomes
Physical activity level
Time frame: Change from Baseline Physical activity level at 12 months
BMI
Time frame: Change from Baseline BMI at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 41660670Dagistan Akgoz A, Gozum S. Integrative, multimodal nursing intervention for uncontrolled hypertension: randomized controlled trial effects on blood pressure, perceived stress, and medication adherence. Clin Hypertens. 2026 Feb 1;32:e6. doi: 10.5646/ch.2026.32.e6. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ongoing treatment in people with Uncontrolled Hypertension and Treatment Compliance, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: For 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.