Acupressure in Acute Stroke Patients

NCT04527237 | Completed

• 1 other identifier: AIBU-HSF-DU-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursing Caries

Keywords

Shiatsu; stroke; Nervousness; Sleep Habits; Vital Signs

Outcome Measures

Primary Outcomes (8)

• Systolic blood pressure (mmHg)

  Systolic blood pressure measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke systolic and diastolic blood pressure measurements are recorded before and after application every 12 hours.

  3 days

• Diastolic blood pressure (mmHg)

  Diastolic blood pressure measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke systolic and diastolic blood pressure measurements are recorded before and after application every 12 hours.

  3 days

• Pulse (beat/minute)

  Pulse measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke pulse measurements are recorded before and after application every 12 hours.

  3 days

• Fever (Cº)

  Fever measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke fever measurements are recorded before and after application every 12 hours.

  3 days

• Respiratory rate (rate/minute)

  Respiratory rate measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke respiratory rate measurements are recorded before and after application every 12 hours.

  3 days

• Oxygen saturation (mmHg)

  Oxygen saturation measurements will be made 15 minutes before and 30 minutes after the acupressure application. After acute stroke oxygen saturation measurements are recorded before and after application every 12 hours.

  3 days

• Anxiety (Spielberger State-Trait Anxiety Inventory / STAI)

  Spielberger State Anxiety Scale: The scores obtained from the scale vary between 20-80, and high scores indicate high anxiety and low scores indicate low anxiety levels. The total score between 0-19 shows that there is no anxiety, the total score between 20-39 indicates mild, the total score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety. Continuity Anxiety Scale states how the person feels in the process, regardless of the situation and conditions. The scores obtained from the scale vary between 20-80. The average score level determined in the applications varies between 36 and 41. 0-30 shows low, 31-49 shows medium, 50-80 shows high anxiety.

  3 days

• Sleep quality (Richard-Campbell Sleep Scale (RCSS))

  The scale will be applied 3 times in total. The scale will be filled in after the night sleep after applying acupressure to the patient twice. In other words, the scale will be filled before acupressure applications on the second, third and fourth day of hospitalization. Each item of the scale is evaluated with visual analog scale technique ranging from 0-100. "0-25" score obtained from the scale indicates "very bad sleep", "76-100" score indicates "very good sleep".

  3 days

Secondary Outcomes (2)

• National Institute of Health Stroke Scale (NIHSS)

  3 days

• Barthel Daily Life Activities Index (BI)

  3 days

Study Arms (2)

acupressure

EXPERIMENTAL

The person will be given 2 applications a day at 12-hour intervals and 6 applications in 72 hours in total.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. In addition, the Continuous Anxiety Scale will be applied once before application, the State Anxiety Scale will be applied once before the application and 3 times in total after the application at the end of every 24 hours. Sleep Scale will be applied 3 times in total before the next day after application. Application to acupressure points in a certain order; Baihui, Susanli, Hegu, Shenmen and Quchi will be held. After 2-3 minutes of approach to the patient and proper positioning, 20 seconds of preparation of each of the notes will be prepared and then 2 minutes acupressure application will be applied to each point.

Other: acupressure

placebo

PLACEBO COMPARATOR

The false acupressure application steps (temperature of the environment, patient's position, application time, frequency and repetition, evaluation period etc.) will be the same as the acupressure application steps. Unlike acupressure, it will only be in contact with wearing gloves to reduce the electrical effect of touch, away from the actual acupressure points. Touching any part of the body or making skin contact can be an effect alone, as well as other meridians and points are located near the existing meridian and selected points, and entering their area of influence, pressing or scrubbing can cause other effects to be activated.

Other: Placebo

Interventions

acupressure OTHER

The person will be given 2 applications a day at 12-hour intervals and 6 applications in 72 hours in total. 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. In addition, the Continuous Anxiety Scale will be applied once before application, the State Anxiety Scale will be applied once before the application and 3 times in total after the application at the end of every 24 hours. Sleep Scale will be applied 3 times in total before the next day after application.

acupressure

Placebo OTHER

Unlike acupressure, it will only be in contact with gloves, to reduce the electrical effect of touch, away from the actual acupressure points.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant İzzet Baysal Üniversitesi

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Dilek Yılmaz, Res Assist

  Bolu Abant Izzet Baysal University Health Sciences Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: August 26, 2020
• Study Start: November 1, 2020
• Primary Completion: May 12, 2021
• Study Completion: December 22, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

TU (1)