How Important Is Acupressure Application in Balancing Heart Rate and Blood Pressure in the Treatment of Atrial Fibrillation? Single-Blind Randomized Experimental Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation is a common cardiac arrhythmia affecting 1-2% of the population. This
      rate is expected to increase in the next 30 years. The aim of this study is to determine the
      effect of acupressure applied to patients with chronic atrial fibrillation on blood pressure
      and heart rate.

      This study was designed as a randomized, placebo-controlled experimental study. As a result
      of the power analysis, 3 groups were formed, each consisting of 23 subjects. No procedure was
      applied to the control group before and after the measurements. In patients in the placebo
      group, an inverted and loose acupressure wristband was attached to the Shenman point to avoid
      applying pressure to any part of the wrist. Acupressure wristbands were applied towards the
      Shenmen point to provide adequate pressure to the patients in the intervention group and
      acupressure was applied twice a day. Acupressure was applied 4 times in two days.
    

Detailed description: 
      1. INTRODUCTION Atrial fibrillation (AF) is a commonly encountered cardiac arrhythmia,
           which affects 1-2% of the population and this rate is expected to increase within the
           next 30 years. The Framingham study, which was started in 1949 and is still ongoing,
           supports this predicted increase by stating that prevalence will increase together with
           age. In developing countries, the mean age of patients with AF is increasing, and is
           currently reported as in the range of 75-85 years . AF is seen in males two-fold more
           than in females . Causing stroke or long-term symptoms such as chest pain, shortness of
           breath, palpitations, listlessness, fatigue, insomnia and activity intolerance, AF
           reduces quality of life .

           There are 3 basic goals in AF treatment. These are control of heart rate, prevention of
           the risk of emboli and the treatment of arrhythmia. AF treatment should be reliable and
           low cost, and previous studies have shown supportive treatments which are low-cost, easy
           to apply, and have no side-effects. In particular, there are studies showing that
           acupuncture is effective in providing heart rate and arrhythmia control in AF.
           Acupressure, which is defined as non-invasive acupuncture is a treatment method that is
           applied using an acustimulation device or by applying physical pressure on certain
           points of the body with the fingers, hand, palm of the hand, wrist, or with a wristband,
           to regulate the disrupted energy balance through the energy channels of the body.
           Although it shows all the effects of acupuncture, it is less known than acupuncture, if
           it is not applied in accordance with the guideline guidelines, it may cause undesirable
           situations.

           It has been emphasised in literature that by stimulating acetylcholine, dopamine and
           encephalon expression, acupressure is effective in muscle relaxation and regulating
           blood circulation. It has been reported that the application of acupressure to patients
           has reduced back pain and headache, pain related to osteoarthritis, musculoskeletal
           system pain, neck pain, and pre and postoperative pain, and because of the reflexive
           effect of acupressure, has reduced nausea and vomiting by increasing the efficacy of the
           hypothalamus, which is an extrapyramidal pathway, has balanced the heart rate and
           reduced sleep disorders.

           As acupressure is not invasive, the acupressure training received within the scope of
           nursing care can be comfortably applied . However, there have been few studies of nurses
           on this subject, and there is a need for studies with a high level of evidence.

           Aim The aim of this study was to determine the effect on blood pressure and heart rate
           of acupressure applied to the Shenman (HT7) point in individuals with chronic AF.

           1.1 Research hypotheses H01: Acupressure applied to the Shenmen (HT7) acupuncture point
           would have no effect on systolic blood pressure in individuals with AF.

           H02: Acupressure applied to the Shenmen (HT7) acupuncture point would have no effect on
           diastolic blood pressure in individuals with AF.

           H03: Acupressure applied to the Shenmen (HT7) acupuncture point would have no effect on
           reducing heart rate in individuals with AF.

           H11: Acupressure applied to the Shenmen (HT7) acupoint has an effect on systolic blood
           pressure in individuals with AF.

           H12: Acupressure applied to the Shenmen (HT7) acupoint has an effect on diastolic blood
           pressure in individuals with AF.

           H13: Acupressure applied to the Shenmen (HT7) acupuncture point is effective in reducing
           heart rate in individuals with AF.

        2. METHOD

      2.1. Study Design and Patient Selection This study was carried out as a pretest-posttest
      placebo, randomized, parallel controlled experimental study conducted between 20.02.2018 and
      20.07.2018 in Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
      Cardiology Intensive Care Unit. In the cardiology department, there are 3 intensive care
      units, 4 isolation rooms, a total of 27 patient beds. Provides tertiary treatment and care
      services.

      In order to specialize in Acupressure, the researcher attended the acupressure course
      organized by the Antalya Health and Nature Therapies Association on February 9-10, 2018,
      which included 16 hours of theoretical and practical courses, and received the acupressure
      certificate. The researcher also attended an 8-hour basic electrocardiography (ECG) course
      and received an EKG course participation certificate.

      Inclusion criteria were patients with chronic AF, >18 years of age, fully conscious, oriented
      and cooperative, with a heart rate of 70-120 beats/min, and no history of recent open heart
      surgery.

      Patients with renal failure (which causes deterioration of heart rhythm and structure), liver
      failure (which affects hemodynamic balance) or hyperthyroidism (increased pulse rate) were
      excluded from the study.

      2.2. Sample selection Between 20.02.2018 and 20.07.2018, a total of 81 patients were treated
      in the ICU, and 12 of them were excluded from the study because they did not meet the
      inclusion criteria. Thus, 69 patients were included in the study . Power analysis was
      performed using G Power 3.1 software to determine the number of patients to be included in
      the placebo, intervention, and control groups. The analysis showed 69 patients in each group
      with 23, d:1.3344, an α-type error estimate of 0.05, and a power of 100% .

      2.3. Randomization and Blinding There were three cardiology intensive care units in the
      hospital where the research was conducted. We recruited placebo, control and experimental
      groups from different intensive care units so that the patients were not affected by each
      other. In this case, each group had to be in the same intensive care unit. We used a system
      to select which ICUs would be placebo, control, or experimental to ensure randomisation. We
      write the numbers 1, 2 and 3 on a piece of paper and put them in a bag. The groups were
      removed from the bag by an impartial nurse working in the ICU (Akbarnezhad et al., 2019).
      Then, we divided the patients into groups from a random number table according to the order
      of hospitalization until the sample power was obtained. The identities of the patients
      participating in the study were kept confidential. In conclusion, this study was conducted as
      a pretest-posttest placebo, randomized, parallel controlled experimental study.

      2.4. Data collection tools In this study, data were collected using the patient information
      form and data registration form.

      2.4.1. Patient Information Form It includes information such as age, height, weight,
      education level, marital status, occupation, employment status, other people they live with,
      medications they use, and social security status of the patients included in the study.

      2.4.2. Data Registration Form It is a form developed by researchers to record blood pressure
      and pulse values before and after the procedure.

      2.5. Process and Interventions

      2.5.1. Placebo Group Patients in the placebo group were informed about what acupressure was
      and why it was administered, and were told that they were in a study examining the effect of
      acupressure on blood pressure and heart rate. In this group, the acupressure wristband was
      placed on both wrists upside down and loosely in order not to apply pressure to the Shenmen
      (HT7) pressure point, and the wristband was worn for 5 minutes, and the procedure was
      completed . Blood pressure and heart rate values were recorded from the monitor before and
      after wearing the wristband at 09:00 in the morning and at 15:00 in the afternoon for two
      consecutive days .

      2.5.2. Acupressure Group Patients in the intervention group were informed about what
      acupressure was and why it was applied, and were told that they were in a study examining the
      effect of acupressure on blood pressure and heart rate. An acupressure wristband was
      correctly fitted on both wrists to provide adequate pressure to the HT7 point for 5 minutes .
      Blood pressure and heart rate values were recorded from the monitor before and after the
      acupressure application at 09:00 in the morning and at 15:00 in the afternoon with a
      wristband for two consecutive days. All data measured in this study were collected from the
      devices and no manual measurements were made.

      2.5.3. Control Group No procedure was applied to the patients in the control group. The
      patients in the control group, on the other hand, were told that only blood pressure and
      pulse values would be measured without giving any information about acupressure within the
      scope of the study . The patients received routine treatment and care.

      2.6. Security assessment Before, during and after the acupressure application, the pulse and
      blood pressure of the patients were continuously monitored in terms of the possibility of
      acupressure application to the heart point to have a negative effect on the pulse and blood
      pressure. During the application of acupressure, the patients were followed up for signs such
      as bradycardia, hypotension, and discomfort. Since the acupressure wristband may impair
      circulation in the arm, the patients were checked for side effects such as cyanosis,
      hematoma, and wrist pain. No complications developed in any patient.

      Acupressure was applied to the patients 4 times in total at 09:00 and 15:00 on the 1st and
      2nd days. Blood pressure and heart rate were measured 8 times before and after each
      procedure.

      2.6.1. Acupressure Practice Guide Acupressure application guide was created as a result of
      expert opinion and literature review.

        -  The patients were informed that acupressure would be applied twice, at 09:00 and 15:00
           on the same day.

        -  Care was taken to ensure that there was an interval of 6 hours between acupuncture
           applications.

        -  Acupressure was applied 4 times in total at 09:00 and 15:00 on two consecutive days.

        -  The patients were told that they may feel slight pain and pressure when pressure is
           applied with the acupressure wristband, and that the procedure can be terminated at any
           time if they feel uncomfortable.

        -  Acupuncture points were determined in each patient using their own fingers.

        -  In order not to make the application on a full stomach, it was applied before the meals
           or at least 1 hour after the meal.

        -  Care was taken to ensure that the application area was suitably lit, quiet and
           adequately ventilated.

        -  Care was taken to ensure that the application area was clean and dry.

        -  Patient privacy was respected.

        -  The patients were placed in the supine position during the application.

        -  Before the application, 1-2 minutes of relaxation massage (effusion) was applied to the
           acupressure areas.

        -  Following the relaxation massage, an acupressure wristband was applied to the HT7 point,
           the chronometer was started, and the acupressure wristband was removed after 5 minutes.

        -  After the procedure, the patients were placed in the semi-Fowler position.

      2.7. Ethical Approval Approval for the study was obtained from Kahramanmaraş Sütçü İmam
      University Faculty of Medicine Clinical Research Ethics Committee (decision dated 31.01.2018
      and numbered 18). On February 20, 2018, the necessary permission for the research was
      obtained from the rector of the same university. Informed consent was obtained from all
      participants participating in the study.

      2.8. Statistical analysis The data obtained in the study were statistically analyzed using
      the Statistical Package for Social Sciences (SPSS) vn. 25.0 software. Descriptive statistics
      were expressed as mean ± standard deviation (SD), number (n) and percent (%). Kruskal Wallis
      Analysis of Variance, Fisher Chi-square test, Posthoc and Wilcoxon tests were used in the
      evaluations. The results were stated at the 95% confidence interval. A p value of <0.05 was
      considered statistically significant.
    

Intervention name(s): How Important Is Acupress Applyıng In Atrıal Fıbrılatıon Treatment?
Intervention type(s): Other
Intervention description(s): The acupressure wristband was correctly attached to the Experimental Group and acupressure was applied. The placebo group was fitted with an inverted and loose acupressure wristband. No intervention was applied to the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Groups with the same trait random, independent, random, application and separated as the control group. Intervention is applied to a group, others are not interfered with, the results are followed by are compared.
It was performed as a single-blind, pretest-posttest placebo, randomized, parallel-controlled experimental study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupressure; atrial fibrillation; blood pressure; heart rate; randomized controlled trial; nursing care