Coronary Angiography (CAG)NCT06779955
Effect of Foot Massage After Coronary Angıography on Back Paın and Vıtal Sıgns
A study testing foot massage application in people with Coronary Angiography (CAG), run by ayşenur kahveci at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the effect of foot massage on patients' back pain and vital signs after coronary angiography. It is important for the transfer of nonpharmacological methods to clinical applications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography (CAG)
- What is being tested?
- foot massage application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Literate
- Over 18 years of age,
- Transfemoral CAG,
- No vision or hearing problems,
- Dorsal pedal and posterior tibial pulses are normal,
- No back pain in the last week before CAG,
Who cannot join
- No physiological or hemodynamic instability during and after CAG,
- Sensory disorders that impair the perception of back pain (paraplegia)
- Active bleeding at the site of cardiac dysrhythmia or catheter insertion,
- Known hemorrhagic disorders,
- History of spinal surgery or herniated disc in the lower back,
- Inflammation or infection in the leg or sole,
- Serious health problems in the feet,
- Not using opioid agents, tranquilizers or anesthetics before, during and 4 hours after CAG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Research Was Planned As a Randomized Controlled Experimental Study to Evaluate the Effects of Foot Massage on Back Pain and Vital Signs in Patients Undergoing Coronary Angiography.
The aim of the study was to evaluate the effect of foot massage on patients' back pain and vital signs after coronary angiography. It is important for the transfer of nonpharmacological methods to clinical applications
Read the detailed description
Cardiovascular diseases are the leading cause of death worldwide. According to the World Health Organization (WHO) data, approximately 393 million people lost their lives due to cardiovascular diseases in 2019. Similarly, when we look at the causes of death in our country, cardiovascular diseases are the leading cause.
Coronary artery disease (CAD), which is among the cardiovascular diseases, is the most important cause of mortality and morbidity. It is also one of the serious diseases that cause significant moral and financial burden on society . Sedentary lifestyle, change in eating habits, smoking, increased life expectancy with advancing technology, diabetes, hypertension and hyperlipidemia increase the prevalence of cardiovascular diseases. The increasing prevalence of risk factors among healthy individuals suggests that the material and moral burden caused by CAD will increase in the near future.
Early diagnosis and treatment are of vital importance in terms of prognosis in coronary artery diseases . Coronary angiography (CAG) is the gold standard in the diagnosis of CAD. Coronary angiography (CAG) and percutaneous transluminal coronary angioplasty (PTCA) are the most commonly used invasive procedures in the diagnosis and treatment of CAD. Complications frequently encountered after the CAG procedure are thromboembolism, bleeding, and hematoma. In order to prevent local vascular complications that may occur at the entry site after the TFA procedure, patients should lie flat in the supine position for approximately 4-8 hours after the procedure, depending on the protocols of each hospital. Although the flat supine position is considered safe, it causes various problems in patients. Studies have shown that lying flat on the back for a long time causes complaints such as orthostatic hypotension, aspiration risk, decreased oxygen saturation, urinary retention, increased cardiac load, and back pain. After coronary angiography, patients mostly complain of back pain, and the incidence of back pain has been reported to be between 11.4% and 26.5% .
Back pain can increase sympathetic stimulation, which can increase heart rate, blood pressure, cardiac load, and myocardial oxygen consumption. These problems contribute to worsening myocardial ischemia. Therefore, management of back pain after CAG is of great importance, especially in patients with serious cardiac problems. Pharmacological and non-pharmacological methods are used in pain management. Although painkillers are the most common pain relief method, they can cause side effects such as inadequate pain relief, respiratory depression, somnolence, nausea, vomiting, and paralytic ileus. Therefore, healthcare professionals frequently apply safer integrated health practices that can reduce pain without causing serious side effects. Integrative health practices such as distraction, music, acupressure, aromatherapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), hot and cold applications and massage are used to reduce pain. Massage reduces pain by reducing cortisol and norepinephrine levels, increasing serotonin levels, stimulating endorphin release, facilitating blood flow, and increasing oxygenation in soft tissues. Another mechanism of action of massage is explained by the gate control theory, which argues that massage stimulates large nerve fibers and thus prevents pain signals from being transmitted to the central nervous system . There are many massage methods, such as whole-body massage, back massage, hand massage, and foot massage. Foot massage is among the most common types of massage. In foot massage, a certain amount of pressure is applied to certain points on the sole, which can affect the parts of the body associated with these points . Foot massage facilitates blood and lymph circulation in the body, thus accelerating the removal of waste products from the body, softening and stabilizing the movements of muscles, joints, and tendons, increasing muscle strength, and providing relaxation. Foot massage is a simple, inexpensive, and noninvasive procedure that can be used anywhere without the need for any special equipment and without compromising patient privacy. Kardan et al. In a study conducted by Kotrucihin et al., it was found that foot massage applied after coronary angiography reduced back pain.
Studies have reported that foot massage has positive effects on sleep quality, blood pressure and anxiety in patients with coronary disease, and that it reduces pain intensity and analgesic use when applied after surgery.
Pain diagnosis and control require teamwork. Within this team, nurses have an indispensable role as the healthcare personnel who spend the longest time with the patient. Relieving the patient's pain and increasing their comfort is an important part of nursing care. Nurses, who perform many applications while performing this task, also use massage, which is the most reliable pain control method.
The aim of this study was to evaluate the effect of foot massage on back pain and vital signs after CAG.
- Conditions
- Coronary Angiography (CAG)
- Being tested
- foot massage application
- Keywords
- CAD, NURSİNG, ayak masajı
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot massage applicationBehavioural
The characteristics of Massage Manipulations are an important feature in planning. Since the purpose of the massage is to rest, calm and relax, Effleurage (Stroke), Petrisage (Kneading) and Friction (Circular Rubbing) techniques that support circulation and have a loosening effect on the tissues have been chosen.A massage will be given to both feet for a total of 16 minutes, 8 minutes for each foot.The person receiving the massage will be lying down comfortably in a supine position, supported by pillows under the head and lower legs.Foot massage will be applied once to patients in the supine position at the first hour after their admission to the coronary intensive care unit following transfemoral angiography.
| Study group | Role | What they receive |
|---|---|---|
| foot massage | Experimental | Pain and vital signs will be assessed for patients in the intervention group half an hour after they have stabilized after angiography. Foot massage will be applied at 1 hour after angiography. 8 minutes of foot massage will be applied to each foot (16 minutes in total for both feet). Vital signs and VAS will be assessed again immediately after the application, at 4 hours and at 8 hours. Receives: Behavioral: foot massage application |
| control group | No intervention | No application will be made to the patients in the control group, and only the routine post-angiography care services of the service will be provided. Pain and vital signs assessment will be repeated half an hour, 1 hour, 4 hours and 8 hours after the patients leave the angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of foot massage after coronary angiography on back pain
Visual Analog Scale, The scale was developed by Freyd M. in 2001. VAS, which is a simple, effective, repeatable and minimally instrumented measurement tool, is a one-dimensional scale frequently used in the measurement of subjective parameters. The scale consists of a 10 cm long line drawn vertically or horizontally. At both ends of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to mark the appropriate place on this line where the pain intensity will intersect. The distance from the lowest VAS level to the patient's mark is measured with a ruler and the numerical value of the patient's pain intensity is obtained in centimeters(cm) or millimeters (mm).
Measured: The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Effect of foot massage after coronary angiography on vital signs
Vital Signs Evaluation Form:Pulse(bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and respiratory rate measurements(breaths/minute) of the patients before and after the procedure will be recorded on the form prepared by the researcher.
Measured: The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Angiography (CAG)Studies 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
- Simple randomization was used in the study.By computer randomization ,patients were divided into intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ayşenur kahveci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ayşenur kahveci, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779955
- Sponsor's protocol ID
- 0000-0003-2304-2994
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pre- and post- implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research Was Planned As a Randomized Controlled Experimental Study to Evaluate the Effects of Foot Massage on Back Pain and Vital Signs in Patients Undergoing Coronary Angiography.
- ClinicalTrials.gov ID
- NCT06779955
- Acronym / sponsor ID
- 0000-0003-2304-2994
- Conditions
- Coronary Angiography (CAG)
- Keywords
- CAD, NURSİNG, ayak masajı
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ayşenur kahveciUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 17 Jan 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.
The aim of the study was to evaluate the effect of foot massage on patients' back pain and vital signs after coronary angiography. It is important for the transfer of nonpharmacological methods to clinical applications
Detailed description
Cardiovascular diseases are the leading cause of death worldwide. According to the World Health Organization (WHO) data, approximately 393 million people lost their lives due to cardiovascular diseases in 2019. Similarly, when we look at the causes of death in our country, cardiovascular diseases are the leading cause.
Coronary artery disease (CAD), which is among the cardiovascular diseases, is the most important cause of mortality and morbidity. It is also one of the serious diseases that cause significant moral and financial burden on society . Sedentary lifestyle, change in eating habits, smoking, increased life expectancy with advancing technology, diabetes, hypertension and hyperlipidemia increase the prevalence of cardiovascular diseases. The increasing prevalence of risk factors among healthy individuals suggests that the material and moral burden caused by CAD will increase in the near future.
Early diagnosis and treatment are of vital importance in terms of prognosis in coronary artery diseases . Coronary angiography (CAG) is the gold standard in the diagnosis of CAD. Coronary angiography (CAG) and percutaneous transluminal coronary angioplasty (PTCA) are the most commonly used invasive procedures in the diagnosis and treatment of CAD. Complications frequently encountered after the CAG procedure are thromboembolism, bleeding, and hematoma. In order to prevent local vascular complications that may occur at the entry site after the TFA procedure, patients should lie flat in the supine position for approximately 4-8 hours after the procedure, depending on the protocols of each hospital. Although the flat supine position is considered safe, it causes various problems in patients. Studies have shown that lying flat on the back for a long time causes complaints such as orthostatic hypotension, aspiration risk, decreased oxygen saturation, urinary retention, increased cardiac load, and back pain. After coronary angiography, patients mostly complain of back pain, and the incidence of back pain has been reported to be between 11.4% and 26.5% .
Back pain can increase sympathetic stimulation, which can increase heart rate, blood pressure, cardiac load, and myocardial oxygen consumption. These problems contribute to worsening myocardial ischemia. Therefore, management of back pain after CAG is of great importance, especially in patients with serious cardiac problems. Pharmacological and non-pharmacological methods are used in pain management. Although painkillers are the most common pain relief method, they can cause side effects such as inadequate pain relief, respiratory depression, somnolence, nausea, vomiting, and paralytic ileus. Therefore, healthcare professionals frequently apply safer integrated health practices that can reduce pain without causing serious side effects. Integrative health practices such as distraction, music, acupressure, aromatherapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), hot and cold applications and massage are used to reduce pain. Massage reduces pain by reducing cortisol and norepinephrine levels, increasing serotonin levels, stimulating endorphin release, facilitating blood flow, and increasing oxygenation in soft tissues. Another mechanism of action of massage is explained by the gate control theory, which argues that massage stimulates large nerve fibers and thus prevents pain signals from being transmitted to the central nervous system . There are many massage methods, such as whole-body massage, back massage, hand massage, and foot massage. Foot massage is among the most common types of massage. In foot massage, a certain amount of pressure is applied to certain points on the sole, which can affect the parts of the body associated with these points . Foot massage facilitates blood and lymph circulation in the body, thus accelerating the removal of waste products from the body, softening and stabilizing the movements of muscles, joints, and tendons, increasing muscle strength, and providing relaxation. Foot massage is a simple, inexpensive, and noninvasive procedure that can be used anywhere without the need for any special equipment and without compromising patient privacy. Kardan et al. In a study conducted by Kotrucihin et al., it was found that foot massage applied after coronary angiography reduced back pain.
Studies have reported that foot massage has positive effects on sleep quality, blood pressure and anxiety in patients with coronary disease, and that it reduces pain intensity and analgesic use when applied after surgery.
Pain diagnosis and control require teamwork. Within this team, nurses have an indispensable role as the healthcare personnel who spend the longest time with the patient. Relieving the patient's pain and increasing their comfort is an important part of nursing care. Nurses, who perform many applications while performing this task, also use massage, which is the most reliable pain control method.
The aim of this study was to evaluate the effect of foot massage on back pain and vital signs after CAG.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple randomization was used in the study.By computer randomization ,patients were divided into intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| foot massage | Experimental | Behavioral: foot massage applicationPain and vital signs will be assessed for patients in the intervention group half an hour after they have stabilized after angiography. Foot massage will be applied at 1 hour after angiography. 8 minutes of foot massage will be applied to each foot (16 minutes in total for both feet). Vital signs and VAS will be assessed again immediately after the application, at 4 hours and at 8 hours. |
| control group | No intervention | –No application will be made to the patients in the control group, and only the routine post-angiography care services of the service will be provided. Pain and vital signs assessment will be repeated half an hour, 1 hour, 4 hours and 8 hours after the patients leave the angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Literate
- Over 18 years of age,
- Transfemoral CAG,
- No vision or hearing problems,
- Dorsal pedal and posterior tibial pulses are normal,
Key exclusion criteria (8 listed)
- No physiological or hemodynamic instability during and after CAG,
- Sensory disorders that impair the perception of back pain (paraplegia)
- Active bleeding at the site of cardiac dysrhythmia or catheter insertion,
- Known hemorrhagic disorders,
- History of spinal surgery or herniated disc in the lower back,
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 |
|---|---|---|
| foot massage applicationThe characteristics of Massage Manipulations are an important feature in planning. Since the purpose of the massage is to rest, calm and relax, Effleurage (Stroke), Petrisage (Kneading) and Friction (Circular Rubbing) techniques that support circulation and have a loosening effect on the tissues have been chosen.A massage will be given to both feet for a total of 16 minutes, 8 minutes for each foot.The person receiving the massage will be lying down comfortably in a supine position, supported by pillows under the head and lower legs.Foot massage will be applied once to patients in the supine position at the first hour after their admission to the coronary intensive care unit following transfemoral angiography. | Behavioural | foot massage |
Primary outcome
Effect of foot massage after coronary angiography on back pain
Time frame: The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Visual Analog Scale, The scale was developed by Freyd M. in 2001. VAS, which is a simple, effective, repeatable and minimally instrumented measurement tool, is a one-dimensional scale frequently used in the measurement of subjective parameters. The scale consists of a 10 cm long line drawn vertically or horizontally. At both ends of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to mark the appropriate place on this line where the pain intensity will intersect. The distance from the lowest VAS level to the patient's mark is measured with a ruler and the numerical value of the patient's pain intensity is obtained in centimeters(cm) or millimeters (mm).
Effect of foot massage after coronary angiography on vital signs
Time frame: The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Vital Signs Evaluation Form:Pulse(bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and respiratory rate measurements(breaths/minute) of the patients before and after the procedure will be recorded on the form prepared by the researcher.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Yes. Pre- and post- implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot massage application in people with Coronary Angiography (CAG), run by ayşenur kahveci 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Jan 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur K KAHVECİ (+90 05315750090, turkmenayse33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of foot massage after coronary angiography on back pain (time frame: The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.). 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 17 Jan 2025.