AcupressureNCT06916351
Effect of Acupressure Applied Before CAG on Pain, Anxiety and Vital Signs
A study testing Acupressure in people with Acupressure and Coronary Angiography and Intervention, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupressure, Coronary Angiography and Intervention
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 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
- Over 18 years of age,
- Able to understand and speak Turkish,
- Open to communication,
- First time undergoing radial artery coronary angiography,
- Elective patients undergoing planned (non-urgent) coronary angiography,
- Patients who did not undergo stent/balloon intervention during angiography,
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- Awake and conscious during coronary intervention (not having taken sedatives (dormicum/fentanyl))
- No deformities or lesions in the areas where acupressure will be applied (hematoma, ecchymosis, etc.)
- Having not taken sedatives or painkillers 5 hours before the angiography,
- No experience with acupressure,
- No history of attending training courses and yoga classes to control stress and anxiety in the last six months
- No diagnosis of anxiety disorder and not receiving medical treatment
- No diagnosis of depression and not receiving medical treatment
- Flat on the back (patients without respiratory distress, etc.),
- Hemodynamically stable (no chest pain or arrhythmia),
- Patients who volunteer to participate in the study,
Who cannot join
- Diagnosed with any psychiatric disease
- Previously undergone coronary angiography from the radial or femoral artery
- Chronic pain
- Used opioid medication
- CAG procedure to be performed from the femoral artery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure Applied Before Coronary Angiography on Pain, Anxiety and Vital Signs in Patients
This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography.
Read the detailed description
This randomized controlled experimental study was conducted at the Kocaeli City Hospital Angiography Unit to determine the effects of acupressure applied before coronary angiography on pain, anxiety and vital signs of the patients scheduled to undergo coronary angiography. It was conducted at the Kocaeli City Hospital Angiography Unit. The study used a stratified block randomization method and 93 patients who met the inclusion criteria were assigned to two different intervention groups, one of which received acupressure and the other a sham intervention before coronary angiography, and a control group receiving standard care. Data were collected using the 'Personal Information Form', 'State Anxiety Inventory (STAI)', 'Visual Analog Scale (VAS)' and 'Patient Follow-up Form'.
- Conditions
- Acupressure, Coronary Angiography and Intervention
- Being tested
- Acupressure, Sham acupressure
- Keywords
- pain, coronary angiography, anxiety, vital signs, Acupressure, nursing care
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure will be applied to a total of three points: the 4th point of the Large Intestine Meridian (LI4-Hegu point) and the 6th point of the pericardial meridian (PC6- Nei Guan point), located three fingers above the wrist.
Sham acupressureOther
Sham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians.
| Study group | Role | What they receive |
|---|---|---|
| Sham acupressure | Placebo comparator | Sham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians. To prepare the points for acupressure, these points will be rubbed for approximately 20-30 seconds without applying direct pressure, reducing tissue sensitivity. The researcher will then apply acupressure to these points and symmetrical points using the thumb for three minutes, but will apply less pressure than required levels. Similar to the acupressure group, preparations and acupressure application will take approximately 20 minutes in total for each patient. Receives: Other: Sham acupressure |
| Control | No intervention | Patients in the control group will not receive any intervention and will receive routine treatment and care. |
| Acupressure | Experimental | Acupressure will be applied to a total of three points, namely HT7, LI4, and PC6, determined by the researcher with a certificate according to literature and expert opinion before the CAG procedure for the acupressure group. The "cun" measurement unit will be used to determine the points where the application will be made. Before the application, after approximately 20-30 seconds of heating and rubbing without direct pressure on the acupressure points, the researcher will manually press the determined acupressure points with the thumb for 10 seconds to create a depth of 1-1.5 cm. Pressure will be applied to each acupressure point for three consecutive minutes (in the breathing rhythm) without lifting the finger, allowing for two seconds of relaxation. Since the symmetry of the three different points selected on the other extremity will also be applied, a total of 18 minutes of pressure will be applied to each point, with the condition of three minutes. Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Scale (STAI)
The State-Trait Anxiety Scale (STAI) is a scale developed by Spielberger et al. in 1970. The STAI determines how an individual feels at a certain moment and under a certain condition. The Turkish adaptation of the STAI was made by Öner and Le Compte in 1983 and the Cronbach alpha coefficient was reported as 0.94 (Öner and Le Compte, 1985). The STAI consists of 20 questions on a four-point Likert type. The statements in the STAI are evaluated as not at all 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A score of 0-19 indicates no anxiety, a score of 20-39 indicates mild, a score of 40-59 indicates moderate and a score of 60-79 indicates severe anxiety. It is stated that those who score 60 points and above need professional help.
Measured: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later
Visual pain scale for pain assessment
The scale is a 10 cm vertical or horizontal line on which patients mark their pain, with no pain written on one end and unbearable pain on the other. The distance between where the patient marks their pain and the no pain range is measured and recorded. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.
Measured: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later
Secondary outcomes (4)
The blood pressure measurements
Blood pressure monitoring will be used to evaluate the effects of acupressure, sham and control groups on physiological signs of pain and anxiety. Systolic and diastolic blood pressure measurements are performed by the researcher using the same manual sphygmomanometer instrument. Blood pressure is expressed in "mmHg".
Measured: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
The heart rate measurement
Heart rate will be used to evaluate the effects of acupressure, sham and control groups on physiological signs of pain and anxiety. Heart rate is measured by the researcher by counting over the radial artery (the untreated artery) for one minute. Heart rate refers to the number of beats per minute.
Measured: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
Respiratory rate
It will be used to evaluate the effects of breathing, acupressure, sham and control groups on physiological signs of pain and anxiety. Respiratory rate is measured by the researcher by counting the inspiratory and expiratory movements of the chest for one minute. Respiratory rate refers to the number of breaths per minute.
Measured: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
Oxygen saturation
Oxygen saturation will be used to evaluate the effects of pain and anxiety on hemodynamic parameters in acupressure, sham and control groups. Oxygen saturation was measured by placing a pulse oximeter on the patient's finger, which was used by the researcher to determine the level of oxygen in the blood. The normal reference range for the evaluation of oxygen saturation expressed as SpO2 was accepted as 95-100%.
Measured: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies 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
- It is a single-blind, parallel group, pre-test-post-follow-up randomized controlled experimental study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarenur Ozen, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916351
- Sponsor's protocol ID
- BandirmaOnyediEylul University
- Other IDs
- Ethics Committee
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied Before Coronary Angiography on Pain, Anxiety and Vital Signs in Patients
- ClinicalTrials.gov ID
- NCT06916351
- Acronym / sponsor ID
- BandirmaOnyediEylul University
- Conditions
- Acupressure, Coronary Angiography and Intervention
- Keywords
- pain, coronary angiography, anxiety, vital signs, Acupressure, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Apr 2025 (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.
This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography.
Detailed description
This randomized controlled experimental study was conducted at the Kocaeli City Hospital Angiography Unit to determine the effects of acupressure applied before coronary angiography on pain, anxiety and vital signs of the patients scheduled to undergo coronary angiography. It was conducted at the Kocaeli City Hospital Angiography Unit. The study used a stratified block randomization method and 93 patients who met the inclusion criteria were assigned to two different intervention groups, one of which received acupressure and the other a sham intervention before coronary angiography, and a control group receiving standard care. Data were collected using the 'Personal Information Form', 'State Anxiety Inventory (STAI)', 'Visual Analog Scale (VAS)' and 'Patient Follow-up Form'.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- It is a single-blind, parallel group, pre-test-post-follow-up randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Sham acupressure | Placebo comparator | Other: Sham acupressureSham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians. To prepare the points for acupressure, these points will be rubbed for approximately 20-30 seconds without applying direct pressure, reducing tissue sensitivity. The researcher will then apply acupressure to these points and symmetrical points using the thumb for three minutes, but will apply less pressure than required levels. Similar to the acupressure group, preparations and acupressure application will take approximately 20 minutes in total for each patient. |
| Control | No intervention | –Patients in the control group will not receive any intervention and will receive routine treatment and care. |
| Acupressure | Experimental | Other: AcupressureAcupressure will be applied to a total of three points, namely HT7, LI4, and PC6, determined by the researcher with a certificate according to literature and expert opinion before the CAG procedure for the acupressure group. The "cun" measurement unit will be used to determine the points where the application will be made. Before the application, after approximately 20-30 seconds of heating and rubbing without direct pressure on the acupressure points, the researcher will manually press the determined acupressure points with the thumb for 10 seconds to create a depth of 1-1.5 cm. Pressure will be applied to each acupressure point for three consecutive minutes (in the breathing rhythm) without lifting the finger, allowing for two seconds of relaxation. Since the symmetry of the three different points selected on the other extremity will also be applied, a total of 18 minutes of pressure will be applied to each point, with the condition of three minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Over 18 years of age,
- Able to understand and speak Turkish,
- Open to communication,
- First time undergoing radial artery coronary angiography,
- Elective patients undergoing planned (non-urgent) coronary angiography,
Key exclusion criteria (5 listed)
- Diagnosed with any psychiatric disease
- Previously undergone coronary angiography from the radial or femoral artery
- Chronic pain
- Used opioid medication
- CAG procedure to be performed from the femoral artery
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 will be applied to a total of three points: the 4th point of the Large Intestine Meridian (LI4-Hegu point) and the 6th point of the pericardial meridian (PC6- Nei Guan point), located three fingers above the wrist. | Other | Acupressure |
| Sham acupressureSham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians. | Other | Sham acupressure |
Primary outcome
State-Trait Anxiety Scale (STAI)
Time frame: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later
The State-Trait Anxiety Scale (STAI) is a scale developed by Spielberger et al. in 1970. The STAI determines how an individual feels at a certain moment and under a certain condition. The Turkish adaptation of the STAI was made by Öner and Le Compte in 1983 and the Cronbach alpha coefficient was reported as 0.94 (Öner and Le Compte, 1985). The STAI consists of 20 questions on a four-point Likert type. The statements in the STAI are evaluated as not at all 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A score of 0-19 indicates no anxiety, a score of 20-39 indicates mild, a score of 40-59 indicates moderate and a score of 60-79 indicates severe anxiety. It is stated that those who score 60 points and above need professional help.
Visual pain scale for pain assessment
Time frame: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later
The scale is a 10 cm vertical or horizontal line on which patients mark their pain, with no pain written on one end and unbearable pain on the other. The distance between where the patient marks their pain and the no pain range is measured and recorded. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.
4 secondary outcomes
The blood pressure measurements
Time frame: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
The heart rate measurement
Time frame: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
Respiratory rate
Time frame: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
Oxygen saturation
Time frame: Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.
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 8 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acupressure and Coronary Angiography and Intervention, run by Bandırma Onyedi Eylül 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 16 inclusion and 5 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 8 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
State-Trait Anxiety Scale (STAI) (time frame: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later). The study lists 2 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 8 Apr 2025.