Acute PainNCT05235841
Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity
A study testing acupressure in people with Acute Pain and Blood Pressure, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to evaluate the effect of acupressure applied before CA procedure on systolic and diastolic blood pressure, mean arterial pressure, pulse and pain intensity parameters after CA. Design: The study is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Blood Pressure
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2018to 26 Dec 2020
- 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 of age and older
- undergoing the coronary angiography process for the first time
- planned coronary angiography
- be able to communicate
Who cannot join
- having psychological or mental disorders
- having a limb amputation
- receiveing therapy such as massage or acupressure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
Official title: Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity of Patients Underwent Coronary Angiography: A Randomized Controlled Trial
Objective: The aim of this study was to evaluate the effect of acupressure applied before CA procedure on systolic and diastolic blood pressure, mean arterial pressure, pulse and pain intensity parameters after CA.
Design: The study is a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients whomet the research criteria.
Read the detailed description
Heart disease is the most important cause of mortality and morbidity in developed and developing countries, despite all preventive and therapeutic initiatives and newly developed methods.Besides the drug treatments, interventional procedures are also used to diagnose and treat some heart diseases, which are life-saving and have few risks. CA, one of the interventional methods commonly used for this purpose, is the process of obtaining cine-angiographic images by injecting contrast agents into femoral, brachial, radial, axillary arteries.
People experience fear of death and consequent anxiety because CA is an invasive diagnostic method. There is a lot of uncertainty about the procedure, and the usage of this method in the diagnosis of an organ with high vital importance, such as the heart, causes fear.High levels of stress cause cardiac irritability and increased blood pressure; while anxiety and stress persist, temporary myocardial ischemia, increased heart rate, palpitations, and chest pain may develop.
The aim of nursing care in CA patients is to ensure the relief and comfort of the patient before, during, and after the procedure, to determine and prevent complications that may develop at an early stage.It is noted that reducing anxiety and pain before and after CA is essential in ensuring the stability of vital signs. Acupressure used for this purpose is a non-pharmacological nursing initiative that can relieve and reduce pain and regulate anxiety-related blood pressure. This study evaluates the impact of acupressure applied before CA on systolic and diastolic blood pressure, mean arterial pressure, pulse, and pain severity parameters after CA.
Design: The study was a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients, met the research criteria were divided into 50 in the intervention (IG) and 50 in the control group (CG) by simple randomization method.
Intervention: The IG received acupressure and the CG received no acupressure. Acupressure was applied to patients in the IG 30-60 minutes before CA. In the study the Li4, HT7, and Extra 1 acupressure points and repeated measures were selected; pain intensity, systolic and diastolic blood pressure and pulse parameters of the patients were measured three times.
- Conditions
- Acute Pain, Blood Pressure
- Being tested
- acupressure
- Keywords
- Acupressure, Coronary Angiography
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Acupressure is a complementary and supportive approach used in symptom management.
| Study group | Role | What they receive |
|---|---|---|
| AG | Experimental | The group that met the criteria of the study and applied acupressure protocol before Coronary Angiography Receives: Other: acupressure |
| CG | No intervention | BEFORE CORONARY ANGIOGRAPHY, THE GROUP WITHOUT ANY INTERVENTION, CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) (T1)
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Measured: Baseline
Visual Analog Scale (VAS) (T2)
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Measured: 5-15 minutes after coronary angiography
Visual Analog Scale (VAS) (T3)
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Measured: 1 hour after the 2nd time VAS assessment
Blood Pressure (T1)
Digital and Calibrated Blood pressure monitor
Measured: Baseline
Blood Pressure (T2)
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Measured: 5-15 minutes after coronary angiography
Blood Pressure (T3)
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Measured: 1 hour after the 2nd time blood pressure measurement
Heart Rate (T1)
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Measured: Baseline
Heart Rate (T2)
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Measured: 5-15 minutes after coronary angiography
Heart Rate (T3)
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Measured: 1 hour after the 2nd time heart rate measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start15 Jul 2018
- Primary completion15 Oct 2018
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- Randomized two arm (intervention and usual care) clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Derya Ister, Kahramanmaras Sutcu Imam University
- Investigators
- emine derya ister, pHD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235841
- Sponsor's protocol ID
- KahramanmarasSIU2021
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derya Ister E, Altinbas Y. Effect of Acupressure on the Blood Pressure, Heart Rate, and Pain Severity of Patients who Underwent Coronary Angiography: A Randomized Controlled Trial. Altern Ther Health Med. 2023 Oct;29(7):216-221.
PubMed 36112790
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity of Patients Underwent Coronary Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05235841
- Acronym / sponsor ID
- KahramanmarasSIU2021
- Conditions
- Acute Pain, Blood Pressure
- Keywords
- Acupressure, Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 11 Feb 2022 (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.
Objective: The aim of this study was to evaluate the effect of acupressure applied before CA procedure on systolic and diastolic blood pressure, mean arterial pressure, pulse and pain intensity parameters after CA.
Design: The study is a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients whomet the research criteria.
Detailed description
Heart disease is the most important cause of mortality and morbidity in developed and developing countries, despite all preventive and therapeutic initiatives and newly developed methods.Besides the drug treatments, interventional procedures are also used to diagnose and treat some heart diseases, which are life-saving and have few risks. CA, one of the interventional methods commonly used for this purpose, is the process of obtaining cine-angiographic images by injecting contrast agents into femoral, brachial, radial, axillary arteries.
People experience fear of death and consequent anxiety because CA is an invasive diagnostic method. There is a lot of uncertainty about the procedure, and the usage of this method in the diagnosis of an organ with high vital importance, such as the heart, causes fear.High levels of stress cause cardiac irritability and increased blood pressure; while anxiety and stress persist, temporary myocardial ischemia, increased heart rate, palpitations, and chest pain may develop.
The aim of nursing care in CA patients is to ensure the relief and comfort of the patient before, during, and after the procedure, to determine and prevent complications that may develop at an early stage.It is noted that reducing anxiety and pain before and after CA is essential in ensuring the stability of vital signs. Acupressure used for this purpose is a non-pharmacological nursing initiative that can relieve and reduce pain and regulate anxiety-related blood pressure. This study evaluates the impact of acupressure applied before CA on systolic and diastolic blood pressure, mean arterial pressure, pulse, and pain severity parameters after CA.
Design: The study was a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients, met the research criteria were divided into 50 in the intervention (IG) and 50 in the control group (CG) by simple randomization method.
Intervention: The IG received acupressure and the CG received no acupressure. Acupressure was applied to patients in the IG 30-60 minutes before CA. In the study the Li4, HT7, and Extra 1 acupressure points and repeated measures were selected; pain intensity, systolic and diastolic blood pressure and pulse parameters of the patients were measured three times.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized two arm (intervention and usual care) clinical trial
| Arm | Type | Receives |
|---|---|---|
| AG | Experimental | Other: acupressureThe group that met the criteria of the study and applied acupressure protocol before Coronary Angiography |
| CG | No intervention | –BEFORE CORONARY ANGIOGRAPHY, THE GROUP WITHOUT ANY INTERVENTION, CONTROL GROUP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 18 years of age and older
- undergoing the coronary angiography process for the first time
- planned coronary angiography
- be able to communicate
Key exclusion criteria (3 listed)
- having psychological or mental disorders
- having a limb amputation
- receiveing therapy such as massage or acupressure.
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 |
|---|---|---|
| acupressureAcupressure is a complementary and supportive approach used in symptom management. | Other | AG |
Primary outcome
Visual Analog Scale (VAS) (T1)
Time frame: Baseline
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Visual Analog Scale (VAS) (T2)
Time frame: 5-15 minutes after coronary angiography
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Visual Analog Scale (VAS) (T3)
Time frame: 1 hour after the 2nd time VAS assessment
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
Blood Pressure (T1)
Time frame: Baseline
Digital and Calibrated Blood pressure monitor
Blood Pressure (T2)
Time frame: 5-15 minutes after coronary angiography
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Blood Pressure (T3)
Time frame: 1 hour after the 2nd time blood pressure measurement
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Heart Rate (T1)
Time frame: Baseline
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Heart Rate (T2)
Time frame: 5-15 minutes after coronary angiography
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Heart Rate (T3)
Time frame: 1 hour after the 2nd time heart rate measurement
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 36112790Derya Ister E, Altinbas Y. Effect of Acupressure on the Blood Pressure, Heart Rate, and Pain Severity of Patients who Underwent Coronary Angiography: A Randomized Controlled Trial. Altern Ther Health Med. 2023 Oct;29(7):216-221.
- Individual participant dataSharing planned: No
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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 derya ister, pHD principal investigator
Kahramanmaras Sutcu Imam University
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 Acute Pain and Blood Pressure, run by Kahramanmaras Sutcu Imam 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (T1) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235841, which also lists 1 linked publication.
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 11 Feb 2022.