Clinical trial NCT06271226: The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters
Official title: The Effect of Acupressure Applied to Intensive Care Patients on Pain and Physiological Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Patients
Pain
Keywords: acupressure
critical care nursing
complementary therapies
pain management
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: neurological evaluation
timeFrame: it is applied to the participants before the start of the study
measure: evaluation of pain
timeFrame: The pain scores of the patients included in the study will be recorded twice a day (morning and evening).
measure: evaluation of physiological parameters
timeFrame: The data of the patients included in the study will be recorded twice a day (morning and evening).
Secondary outcomes:
measure: evaluation of physiological parameters
timeFrame: The data of the patients included in the study will be recorded twice a day (morning and evening) for 2 days.
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun Eğitim Araştırma Hastanesi
Study officials:
affiliation: Ondokuz Mayıs universty
name: emine yaman lezki
role: PRINCIPAL_INVESTIGATOR
References: