Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05350397 |
| Other study ID # |
KSUanestezia |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2018 |
| Est. completion date |
July 20, 2018 |
Study information
| Verified date |
March 2023 |
| Source |
Kahramanmaras Sutcu Imam University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
