Clinical trial NCT04527237: Acupressure in Acute Stroke Patients
Official title: Acupressure Physiological Parameters in Patients With Acute Stroke, Its Effect on Anxiety and Sleep Quality: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Keywords: Shiatsu
stroke
Nervousness
Sleep Habits
Vital Signs
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: To examine the effect of acupressure application on physiological parameters, anxiety and sleep quality in patients with acute stroke.

Method: Randomized controlled trial will be carried out in the stroke patients in Turkey. The research will include two groups, an intervention (n=32) and a placebo (n=32).

Since the critical period in the care of the patient who had an acute stroke is the first 72 hours;

* An application and evaluation will be made every 12 hours after the first application. In other words, a person will be given 2 applications a day with an interval of 12 hours and a total of 6 applications within 72 hours.
* Depending on the number of points selected and the duration of the print on each point; the session duration of an individual will be approximately 25 minutes.
* Physiological measurements will be made before and after the acupressure application. Physiological measurements 10-15 min. From acupressure application. will be taken before and the same measurements after acupressure 20-30. Will be taken again in the min interval.
* Application to acupressure points in a certain order; Baihui (GV20), Susanli (ST36), Hegu (LI4), Shenmen (HT 7) and Quchi (LI11) will be held.

The application steps of the placebo group will be the same as the acupressure application steps. Unlike acupressure, it will be waited for 2 minutes only in contact with the thumb, without any pressure or scrub on the bone protrusions, away from the real acupressure points, where the meridian does not pass and there are no active points. To reduce the electrical effect of the touch, gloves will be worn only in contact.

Detailed description: Stroke is a medical emergency and 25% of patients experience neurological deterioration 24-48 hours after stroke. After stroke, 15-30% of patients live with permanent sequelae, and 20% become in need of care. Therefore, the care provided in the acute period (24-72 hours) is critical in shaping recovery and prognosis. It is possible to prevent neurological and medical complications with safe and effective stroke care (Boyraz 2015).

There are many factors that affect the occurrence of complications in patients with acute stroke. The most common of these factors are increased blood pressure, decreased oxygen saturation, fever, heart rate and respiratory rate physiological parameters. The follow-up and control of physiological parameters is of vital importance, especially in patients with acute stroke (Greer et al.2008; Uzuner, Steiner et al.2014; Kutluk and Balkan 2015). In addition, it is stated that the sudden change in the health status of the individual, the emergence of anxiety due to the hospitalization process and the inability to perform daily life activities, the difficulty in adapting to the treatment process, and the disruption of sleep patterns may be effective in the emergence of complications (Jariani et al 2011).

Despite the symptoms or complications of stroke, it is one of the most important goals of health care to make patients feel good and help them to continue their daily life activities (Ovayol and Ovayol 2016). Among the nursing interventions applied to relieve these symptoms or complications, there are complementary and alternative treatment (CAM) methods (Khorshid 2005; Taşçı 2015). Many of the CAM methods are similar to nursing practices in terms of focusing on the holistic concept (Taşçı 2015).

In the literature, it is stated that acupressure application, which is among the CAM methods in stroke patients, is frequently used and is an effective application (Song et al.2015; Shın and Lee 2007; Kang, Sok, and Kang 2009; Yue, Jiang, and Wong 2012). Acupressure (Shiatsu) is a massage technique applied with fingers and palms, based on traditional Chinese Medicine, consisting of the words shi = finger = and atsu = pressure. Acupressure is one of the oldest healing methods. This method ensures proper functioning of energy channels (such as blood circulation) by applying pressure to acupuncture points with fingers, palms, tennis balls or special stimulation tools to activate the self-healing power of the body, regulate energy flow, and relieve uncomfortable symptoms. The acupressure technique is a noninvasive, safe, effective method that has no side effects (Song et al.2015; Mucuk and Ceyhan 2015). Although acupressure application is included in the Nursing Interventions Classification (NIC), it is a method that increases the independent functions of the nurse and improves the patient and nurse interaction (Özkan and Balcı 2018).

As a result of the literature review, it has been proven that acupressure applications are effective in coping with many symptoms and complications in stroke patients, but there is no study examining the effect of acupressure application on the control of physiological parameters, anxiety and sleep quality in patients with acute stroke in the world and in our country. Considering that acupressure application is a non-invasive, safe and effective method, it is thought that the application of acupressure in the acute stroke period can reduce the development rate of complications, increase the quality of healing, reduce the patient's anxiety and increase the patient's sleep quality, and more evidence-based studies can be undertaken to defend its effectiveness clearly. is needed.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with acute stroke,
* Patients arriving at the clinic within 24 hours from the onset of stroke,
* Patients who have had a stroke for the first time,
* NIHSS \<16,
* Turkish-speaking patients,
* Patients who can speak,
* Patients 18 and older,
* Patients without neurological diseases other than stroke,
* Patients who agree to participate in the study,
* Patients who are willing to access medical records since hospitalization.

Exclusion Criteria:

* Patients diagnosed other than stroke (such as subarachnoid hemorrhage, aneurysm, dementia, psychiatric disease),
* Having a malignancy,
* The existence of unstable Angina Pectoris,
* Having congestive Heart Failure.

Primary outcomes:
measure: Systolic blood pressure (mmHg)
timeFrame: 3 days
measure: Diastolic blood pressure (mmHg)
timeFrame: 3 days
measure: Pulse (beat/minute)
timeFrame: 3 days
measure: Fever (Cº)
timeFrame: 3 days
measure: Respiratory rate (rate/minute)
timeFrame: 3 days
measure: Oxygen saturation (mmHg)
timeFrame: 3 days
measure: Anxiety (Spielberger State-Trait Anxiety Inventory / STAI)
timeFrame: 3 days
measure: Sleep quality (Richard-Campbell Sleep Scale (RCSS))
timeFrame: 3 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 3 days
measure: Barthel Daily Life Activities Index (BI)
timeFrame: 3 days
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant İzzet Baysal Üniversitesi
Study officials:
affiliation: Bolu Abant Izzet Baysal University Health Sciences Faculty
name: Dilek Yılmaz, Res Assist
role: PRINCIPAL_INVESTIGATOR
References: