Coronary AngiographyNCT06312397
The Effect on Back Pain and Fatigue Level of Acupressure
A study testing Acupressure in people with Coronary Angiography, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 30 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned coronary angiography from the femoral region
- Not diagnosed with low back pain
- No stent or other interventional procedure was performed during the coronary angiography procedure.
Who cannot join
- Those who have had acupressure before for any purpose
- Problems such as bleeding and dysrhythmia occur after coronary angiography,
- Those with burns, scars, scratches and deformities at the acupressure point
- Having any psychological disorder,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Birgül VURAL DOĞRU
Mersin, 33110
Birgül VURAL DOĞRU, Associate Professor, 03243610001, bvuraldogru@gmail.com
About this study
Official title: The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study
This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.
Read the detailed description
To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.
Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.
According to G-power analysis, the total number of samples was calculated as 120.
A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).
A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.
- Conditions
- Coronary Angiography
- Being tested
- Acupressure, Sham acupressure
- Keywords
- Coronary angiography, Acupressure, Low back pain, Fatigue, Muscle
- Medical subject headings
- Low Back Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity The symmetry of the three selected different points will also be applied to the other extremity.
After coronary angiography, acupressure will be applied for a total of 15 minutes.
Sham acupressureOther
In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Active comparator | After coronary angiography, acupressure will be applied for a total of 15 minutes. For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity.
The symmetry of the three selected different points will also be applied to the other extremity. Receives: Other: Acupressure |
| Sham acupressure | Placebo comparator | In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass. Receives: Other: Sham acupressure |
| Control group | No intervention | With the control group, no intervention was conducted, and only standard care was given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Pain
It is used to measure subjectively perceived pain. On the scale, which includes the numbers between 0 and 10 cm, which are the most commonly used to determine the intensity of pain quantitatively, with painlessness at one end and the most severe pain possible at the other end, "0" defines painlessness and "10" defines the most severe pain.
Measured: 1 year
Visual Analog Scale for Fatigue
The fatigue scale is a 10 cm scale that evaluates the severity of fatigue ranked from 0 to 10.
On the left side of the scale, there is a rating of "I do not feel tired", and on the right side, there is a rating of "I feel extreme fatigue and exhaustion".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start4 Mar 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
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 Coronary AngiographyStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Three groups ( acupressure group, sham acupressure group and control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgul Vural Dogru, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312397
- Sponsor's protocol ID
- MU-HF-BVD-01
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vural Dogru B, Ozbay H, Aktan A. The effect on back pain and fatigue level of acupressure after coronary angiography: A randomized single-blind sham-controlled study. Pain Manag Nurs. 2026 Sep 11:S1524-9042(26)00273-0. doi: 10.1016/j.pmn.2026.08.012. Online ahead of print.
PubMed 42728195
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT06312397
- Acronym / sponsor ID
- MU-HF-BVD-01
- Conditions
- Coronary Angiography
- Keywords
- Coronary angiography, Acupressure, Low back pain, Fatigue, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 15 Mar 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.
This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.
Detailed description
To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.
Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.
According to G-power analysis, the total number of samples was calculated as 120.
A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).
A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups ( acupressure group, sham acupressure group and control group)
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Active comparator | Other: AcupressureAfter coronary angiography, acupressure will be applied for a total of 15 minutes. For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity. The symmetry of the three selected different points will also be applied to the other extremity. |
| Sham acupressure | Placebo comparator | Other: Sham acupressureIn the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass. |
| Control group | No intervention | –With the control group, no intervention was conducted, and only standard care was given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned coronary angiography from the femoral region
- Not diagnosed with low back pain
- No stent or other interventional procedure was performed during the coronary angiography procedure.
Key exclusion criteria (4 listed)
- Those who have had acupressure before for any purpose
- Problems such as bleeding and dysrhythmia occur after coronary angiography,
- Those with burns, scars, scratches and deformities at the acupressure point
- Having any psychological disorder,
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 |
|---|---|---|
| AcupressureFor the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity The symmetry of the three selected different points will also be applied to the other extremity. After coronary angiography, acupressure will be applied for a total of 15 minutes. | Other | Acupressure group |
| Sham acupressureIn the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass. | Other | Sham acupressure |
Primary outcome
Visual Analog Scale for Pain
Time frame: 1 year
It is used to measure subjectively perceived pain. On the scale, which includes the numbers between 0 and 10 cm, which are the most commonly used to determine the intensity of pain quantitatively, with painlessness at one end and the most severe pain possible at the other end, "0" defines painlessness and "10" defines the most severe pain.
Visual Analog Scale for Fatigue
Time frame: 1 year
The fatigue scale is a 10 cm scale that evaluates the severity of fatigue ranked from 0 to 10. On the left side of the scale, there is a rating of "I do not feel tired", and on the right side, there is a rating of "I feel extreme fatigue and exhaustion".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 42728195Vural Dogru B, Ozbay H, Aktan A. The effect on back pain and fatigue level of acupressure after coronary angiography: A randomized single-blind sham-controlled study. Pain Manag Nurs. 2026 Sep 11:S1524-9042(26)00273-0. doi: 10.1016/j.pmn.2026.08.012. Online ahead of print.
Related trials for Coronary Angiography
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
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.
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 Coronary Angiography, run by Mersin 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 3 inclusion and 4 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 15 Mar 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT06312397, 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 15 Mar 2024.