The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters

Pain Clinical Trial

— EFFECTOFACU  

Official title:

The Effect of Acupressure Applied to Intensive Care Patients on Pain and Physiological Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271226
• Other study ID #: OMUKAEK 2022/75
• Secondary ID: OMUKAEK 2022/75
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ondokuz Mayis University
• Contact: emine yaman lezki
• Phone: +90 05458026622
• Email: e_yaman95[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation). The main questions that the study aims to answer are: Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters. Acupressure applied to intensive care patients has an effect on physiological parameters. Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain.

Description:

This study is planned to be conducted as a single-blind randomized placebo-controlled-experimental. Patients for randomization will be divided into three groups as experimental, control and plesobo (without true acupressure). Before the patients in the intensive care unit are included in the study, the state of consciousness with the Glasgow coma scale (GCS) and their pain will be evaluated with the pain scale. Patients with a GCS of 9 and above and who have pain will be included in the study. Acu points to be used in the study: HT7, P6, P7, Li4, Lv3 points. Li4 and Lv3 are often associated with pain; HT7, P6 and P7 points are especially related to the heart and pericardium. In the first session of the acupressure intervention to be applied to the experimental group, the patients will be informed about how to perform the application. In order to ensure the physical comfort of the patient, the intervention times will be determined with two application intervals of 4 hours. Physiological parameters and pain score of the experimental group will be recorded before the procedure, then hands will be washed in line with the preparation for acupressure application, and supine or semifowler position will be given according to the patient's preference, taking into account the privacy of the patient. Pressure points will be determined using the patient's own finger measurements. Before pressing, a relaxing-relaxing patting motion will be applied to these points for 10 seconds. Afterwards, pressure will be applied to each point twice a day (morning and evening) with the thumb for 1.5 minutes, with 5 seconds of pressure and 1 second of free pressure on each point. It will take 15 minutes to press all points in total. At the end of the application and at 15 minutes and 30 minutes after the application, the participant's physiological parameter data and pain score will be re-evaluated and recorded. These data will be recorded 2 times a day (morning and evening) for 2 days. In the placebo group, the preparations and forms applied to the experimental group will be applied in the same way, but in accordance with the literature, an area 1.5 cm away from the acupressure point that has no connection with the acupressure point will be selected and the application will be made in the form of light touch. In the control group, pain and physiological parameters will be monitored and recorded twice a day (morning and evening) for 2 days without any application during the study (except for the routine treatment given by the physician).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being 18 years or older
• Volunteering to participate in the research.
• Getting a score of 9 and above on the Glasgow Coma Scale and being able to communicate meaningfully,
• Oxygen saturation of 85 and above
• Mean arterial pressure of 65 mmHg and above

Exclusion Criteria:

• Diagnosis of suspected acute stroke bleeding
• Taking antihypertensive and beta-blocker drugs the start of the study
• Receiving sedation (dormicum, propofol, brunette)
• Presence of ulcers, bilateral paralysis, necrotic tissue and signs of infection (fever, redness, discharge, temperature) at the pressure points
• Situations that will cause the participant to leave the study (death, transfer to another unit, discharge or unwillingness to continue working)
• Receiving inotropic therapy (dopamine, steradine, etc.)
• Absence of analgesic therapy in routine treatment.

Related Conditions & MeSH terms

• Intensive Care Patients
• Pain

Intervention

Other:
• acupressure
With acupressure, massage or pressure is applied to certain points on the body with fingers, hands or palms. The pressed points are the points on the skin that are sensitive to bioelectrical impulses and can easily transmit them.
• placebo acupressure
n the placebo group, the preparations and forms applied to the experimental group will be applied in the same way, but in accordance with the literature, an area 1.5 cm away from the acupressure point that has no connection with the acupressure point will be selected and the application will be made in the form of light touch
• control group
During the study, pain and physiological parameters will be monitored and recorded twice a day (morning and evening) for 2 days, without any application (other than the routine treatment given by the physician).

Locations

Country	Name	City	State
Turkey	Giresun Egitim Arastirma Hastanesi	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurological evaluation	It will be evaluated using the Glaskow Coma scale. With the Glaskow Coma scale, three main functions of the patients, namely eye opening, verbal and motor, are evaluated and scored. Patients' eye opening is scored as 1-4 points, verbal response as 1-5 points, and motor response as 1-6, and the level of consciousness is determined by the total score. As the score of the scale increases, the risk of mortality decreases and the level of awareness increases.	it is applied to the participants before the start of the study
Primary	evaluation of pain	Visual Analog Scale is a one-dimensional measurement tool used to evaluate the pain perceived by the person. The scale is 0-10 cm or 0-100 mm, with no pain (0) at one end, and the worst possible pain (10) at the other end.In the evaluation of VAS, 0 cm = no pain, 0.5-3 cm = mild pain, 3.5-6.5 cm = moderate pain, 7-10 cm = severe pain.	The pain scores of the patients included in the study will be recorded twice a day (morning and evening).
Primary	evaluation of physiological parameters	the physiological parameter was recorded with the registration form.This form includes the patients' blood pressure, heart rate, respiration and SPO2 values.	The data of the patients included in the study will be recorded twice a day (morning and evening).
Secondary	evaluation of physiological parameters	blood pressure,heart rate,number of breaths,oxygen saturation	The data of the patients included in the study will be recorded twice a day (morning and evening) for 2 days.