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).
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.
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.
- Conditions
- Hypertension, Train Sickness
- 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 group | Role | What they receive |
|---|---|---|
| Patient Education | Experimental | The 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 Group | No intervention | Routine 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.
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)
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.
- First posted25 Jul 2024
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kader ÖZTÜRK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kader ÖZTÜRK, Ataturk University
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given According to the Roy Adaptation Model on the Sleep and Quality of Life of Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT06521242
- Acronym / sponsor ID
- Kader
- Conditions
- Hypertension, Train Sickness
- Keywords
- Nursing, Hypertension, Roy Adaptation Model, Sleep Quality, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kader ÖZTÜRKUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 25 Jul 2024 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Experimental | Other: Patient EducationThe 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. |
| Control Group | No intervention | –Routine nursing care was given to the patients in this group without any training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Incomplete data form
- Leaving the study at any stage
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 |
|---|---|---|
| Patient EducationThe intervention group was given 120 minutes of training. | Other | Patient Education |
Primary outcome
Pittsburg Sleep Quality Index (PSQI)
Time frame: up to eight weeks
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.
1 secondary outcome
SF-36 Quality of Life Scale
Time frame: up to eight weeks
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 25 Jul 2024.
- Individual participant dataSharing planned: No
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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 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.