Intensive Care PatientsEFFECTOFACUNCT06271226
The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters
A study testing acupressure in people with Intensive Care Patients and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients, Pain
- What is being tested?
- acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Giresun Eğitim Araştırma Hastanesi
Giresun, 28000
emine yaman lezki, +9005458026622, e_yaman95@hotmail.com
About this study
Official title: 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:
Read more
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.
Read the 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).
- Conditions
- Intensive Care Patients, Pain
- Being tested
- acupressure, placebo acupressure, control group
- Keywords
- acupressure, critical care nursing, complementary therapies, pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Also called finger pressure
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 acupressureOther
Also called sham 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 groupOther
Also called follow up
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).
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | 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. Receives: Other: acupressure |
| plasebo acupressure | Active comparator | 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. Receives: Other: placebo acupressure |
| control group | Other | 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). Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
blood pressure,heart rate,number of breaths,oxygen saturation
Measured: The data of the patients included in the study will be recorded twice a day (morning and evening) for 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PatientsStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yaman Lezki, Ondokuz Mayıs University
- Investigators
- emine yaman lezki, Principal investigator, Ondokuz Mayıs universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271226
- Sponsor's protocol ID
- OMUKAEK 2022/75
- Other IDs
- OMUKAEK 2022/75
- Acronym
- EFFECTOFACU
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study results can be shared at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied to Intensive Care Patients on Pain and Physiological Parameters
- ClinicalTrials.gov ID
- NCT06271226
- Acronym / sponsor ID
- EFFECTOFACU / OMUKAEK 2022/75
- Conditions
- Intensive Care Patients, Pain
- Keywords
- acupressure, critical care nursing, complementary therapies, pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressureInformation 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 comparator | Other: placebo acupressureIn 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 | Other | Other: control groupDuring 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressureAlso: finger pressureWith 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 | acupressure |
| placebo acupressureAlso: sham acupressuren 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 | plasebo acupressure |
| control groupAlso: follow upDuring 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 |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Yes. study results can be shared at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emine yaman lezki principal investigator
Ondokuz Mayıs universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Intensive Care Patients and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emine yaman lezki (+90 05458026622, e_yaman95@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurological evaluation (time frame: it is applied to the participants before the start of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.