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HypertensionNCT06521242

The Effect of Training Given to With Hypertension

A study testing Patient Education in people with Hypertension and Train Sickness, run by Kader ÖZTÜRK at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study was conducted to examine the effects of the training given according to the Roy Adaptation Model on the sleep and quality of life of individuals with hypertension. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, Train Sickness
What is being tested?
Patient Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2021to 26 Dec 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being diagnosed with hypertension for at least 6 months
  • Having applied to clinics for follow-ups
  • Knowing the diagnosis and being able to express it verbally
  • Not having a communication problem
  • Being literate

Who cannot join

  • Incomplete data form
  • Leaving the study at any stage

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Turkey

    Erzurum, Yakutiye, 25100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Training Given According to the Roy Adaptation Model on the Sleep and Quality of Life of Individuals With Hypertension

The study was conducted to examine the effects of the training given according to the Roy Adaptation Model on the sleep and quality of life of individuals with hypertension.

Read the detailed description

Nurses have responsibilities in the treatment of hypertension, especially in controlling blood pressure and risk factors. Patient evaluation, diagnosis, follow-up, medication management, patient training, counseling, and clinical management of patients are among the responsibilities of nurses. It has been reported in previous studies that insufficient sleep duration and sleep apnea cause hypertension. Hypertension patients have been reported to have lower sleep quality scores when compared to individuals with normal blood pressure.

Training given by nurses on issues such as the importance of sleep, providing the necessary sleep time, and resting the individual can turn hypertension into a controllable disease. Previous studies reported that hypertension reduces the quality of life of individuals. Quality of life of hypertension patients is affected by factors such as age, gender, educational status, genetics, and the negative consequences of the disease. These negative consequences can be organ damage, side effects of drugs used, other diseases, obesity, and sexual dysfunctions. The negative psychological state of patients can affect blood pressure, quality of life, and sleep patterns negatively.

Nurses come to the forefront especially with their educational roles in preventive healthcare services, ensuring adaptation to disease and rehabilitation services. One of the most common models used to guide nursing practice and training is the Roy Adaptation Model (RAM) in nursing. Since RAM is functional in compliance with treatment and coping with chronic diseases, it is used as a conceptual model to construct and test nursing theories.

In a study that was conducted by Seah and Tham using RAM, it was reported that individuals adapted better to their disease in a changing environment in the treatment of bulimia nervosa. In the study of Afrasiabifar, Karimi, and Hassani, it was reported that patient training based on RAM strengthened the adjustment in the physiological state and self-concept areas of patients. It was found in another study that patients who received RAM training used effective coping mechanisms to adapt to various symptoms and responded more positively to treatment. In a study conducted by Lok et al., it was found that Cognitive Stimulation Therapy significantly increased the quality of life. Also, in another study that was conducted according to RAM, it was reported that web-based training increased the quality of life significantly in the physiological field.

There may be problems in compliance with the disease, symptoms, disease management, and treatment in hypertension patients. Patient training given by nurses is important in ensuring compliance with the disease, treatment, and care of hypertension patients. It is considered that the training based on RAM will be beneficial in the training to be given by nurses. Studies conducted in Turkey show that it is necessary to increase social awareness about hypertension and use model-based training by nurses who provide care. Because patient compliance is mainly focused on in patient training in the treatment process of hypertension and it is considered the most important variable in the treatment process. The present study was conducted to determine the effects of the training given according to RAM on sleep and quality of life in patients diagnosed with hypertension.

Being tested
Patient Education
Keywords
Nursing, Hypertension, Roy Adaptation Model, Sleep Quality, Quality of Life
Medical subject headings
Hypertension, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient EducationOther

    The intervention group was given 120 minutes of training.

Study groups in NCT06521242
Study groupRoleWhat they receive
Patient EducationExperimentalThe RAM-Based Training and Hypertension Training Manual were given to the intervention group for 8 weeks, once a week, for 2 hours each session. The patients in the intervention group were called during the 1st and 3rd weeks of the study, and telephone counseling was provided. Reminders were made for important points in RAM-based hypertension training in these meetings.
Receives: Other: Patient Education
Control GroupNo interventionRoutine nursing care was given to the patients in this group without any training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburg Sleep Quality Index (PSQI)

    The index was developed by Buysse et al. in 1989 to evaluate the sleep duration and intensity of individuals. The scale has 11 items and 7 sub-dimensions. These items are scored between 0-3. The scores that can be obtained from the scale range from "0" to "21" points. The Turkish validity and reliability of the scale was conducted by Ağargün et al. in 1996. A high total scale score indicates poor sleep quality. A reliable, valid, and standard measurement of sleep quality is made with PSQI. The Cronbach Alpha Internal Consistency Coefficient of the scale is 0.80.

    Measured: up to eight weeks

Secondary outcomes (1)
  1. SF-36 Quality of Life Scale

    The scale, which is widely used in health-related quality-of-life studies, was developed by Ware and Sherbourne. A high score on the scale indicates a good quality of life. The scores that can be obtained from the sub-dimensions and the sum of the scale vary between 0-100. A score approaching zero indicates poor health and 100 indicates good health. The Turkish validity and reliability of the scale was conducted by Pınar in 1995.

    Measured: up to eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start1 Jul 2021
  3. Primary completion1 Dec 2022
  4. Study completion26 Dec 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521242
Sponsor's protocol ID
Kader
Status last verified
Jul 2024
First submitted
26 Jun 2024
Last updated
25 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Patient Education in people with Hypertension and Train Sickness, run by Kader ÖZTÜRK 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 2 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 25 Jul 2024. 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?

Pittsburg Sleep Quality Index (PSQI) (time frame: up to eight weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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