The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters
EFFECTOFACU
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2023
CompletedFirst Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 21, 2024
February 1, 2024
1.3 years
September 19, 2023
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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).
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 Outcomes (1)
evaluation of physiological parameters
The data of the patients included in the study will be recorded twice a day (morning and evening) for 2 days.
Study Arms (3)
acupressure
EXPERIMENTALInformation 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.
plasebo acupressure
ACTIVE COMPARATORIn 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
OTHERDuring 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).
Interventions
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.
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
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giresun Eğitim Araştırma Hastanesi
Giresun, 28000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
emine yaman lezki
Ondokuz Mayıs universty
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- participant and statistical analysis expert is blind.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- expert nurse
Study Record Dates
First Submitted
September 19, 2023
First Posted
February 21, 2024
Study Start
March 20, 2023
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- study results can be shared at the end of the study
- Access Criteria
- when the study is concluded, the data can be accessed within the limits determined by the principal investigator.
study results can be shared at the end of the study