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

February 14, 2024 updated by: Emine Yaman Lezki, Ondokuz Mayıs University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Giresun, Turkey, 28000
        • Recruiting
        • Giresun Eğitim Araştırma Hastanesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupressure
Information about the pre-procedure intervention will be given. Before acupressure, the participant's physiological parameters and pain score will be recorded, then the hands will be washed in preparation for the acupuncture application and the patient will be placed in a supine or semi-sitting position. Compression points are HT7, P6, P7, Li4, Lv3 points and the location will be determined by the patient's own finger size. Before pressing, a relaxing-relaxing patting motion will be applied to these points for 10 seconds. Then, 1.5 minutes, 5 seconds of thumb pressure and 1 second of free pressure to each point will be applied to each point twice a day (morning and evening). In total it will take 15 minutes to press all the dots. At the end of the application and 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 twice a day (morning and evening) for 2 days.
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.
Other Names:
  • finger pressure
Active Comparator: plasebo acupressure
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.
Other: 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
Other Names:
  • sham acupressure
Other: 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).
Other: 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).
Other Names:
  • follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurological evaluation
Time Frame: it is applied to the participants before the start of the study
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
evaluation of pain
Time Frame: The pain scores of the patients included in the study will be recorded twice a day (morning and evening).
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).
evaluation of physiological parameters
Time Frame: The data of the patients included in the study will be recorded twice a day (morning and evening).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of physiological parameters
Time Frame: The data of the patients included in the study will be recorded twice a day (morning and evening) for 2 days.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: emine yaman lezki, Ondokuz Mayıs Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMUKAEK 2022/75 (Other Identifier: ONDOKUZ MAYIS UNIVERSTY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study results can be shared at the end of the study

IPD Sharing Time Frame

study results can be shared at the end of the study

IPD Sharing Access Criteria

when the study is concluded, the data can be accessed within the limits determined by the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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