Foot ReflexologyNCT05631522
Effect of Foot Reflexology on Pain Associated With Mediastinal Chest Drain Removal
A study testing foot reflexology in people with Foot Reflexology, run by Mansoura University.
Trial summary
Cardiovascular diseases (CVDs) remain the leading cause of death worldwide and significantly affect patient quality of life and socioeconomic status. The care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Reflexology
- What is being tested?
- foot reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 28 Feb 2023
- 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
- Adult conscious patients ≥ 18 years old after OHS, who have a mediastinal chest drain.
- Gender: male and female
Who cannot join
- 1. Sedated patients 2. Patients with any problem in the foot as a wound, allergy, injury, pain, callus, corn, fungal skin infection, or previous scars.
- 3. Patients use analgesics for 6 hours before the intervention.
About this study
Official title: The Effect of Foot Reflexology on Pain Severity Associated With Mediastinal Chest Drain Removal in Patients Undergoing Open-Heart Surgery
Cardiovascular diseases (CVDs) remain the leading cause of death worldwide and significantly affect patient quality of life and socioeconomic status. The care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. The burden of CVD and the high prevalence of CVD risk factors in Egypt are alarming.
Despite great evidence of adverse clinical impact, the pain remains infrequently assessed and poorly managed in ICU. Pain has serious physical and psychological effects which can impair patient recovery and discharge. Moreover, it does not allow the patients to collaborate appropriately during care-related procedures, such as mobilization and respiratory therapy.
Read the detailed description
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is commonly associated with an increased risk of blood clots and build-up of fatty deposits inside the arteries. CVD is the leading global cause of death accounting for more than 17.9 million deaths per year in 2019, representing 32% of all global deaths. Of these deaths, 85% were due to heart attack and stroke (World Health Organization [WHO], 2021). Mortality rate due to CVD is expected to grow to more than 23.6 million by 2030 (American Heart Association [AHA], 2017). In Egypt, the CVD mortality rate accounts for 46% of total deaths from all ages for both sexes (WHO, 2014).
There are many options for treating CVD, one of these options is open-heart surgery (OHS) especially coronary artery bypass graft (CABG) and valvular surgeries. CABG is done in patients with severe narrowing of the coronary arteries that do not respond to other treatment. Patients after OHS are usually transferred to the intensive care unit (ICU) to receive advanced medical care and close monitoring. They may suffer pain after OHS for various reasons including sternum incision, tissue excision, removal of saphenous vein, and the presence of chest drain as well as various factors related to the type of operation). Patients in the ICU are also exposed to many invasive and noninvasive painful procedures for diagnostic or therapeutic purposes.
Mediastinal chest drain placement (MCDP) and removal is one of these painful procedures. MCDP is a part from the standard care in cardiac surgery to assist the clearance of blood from the pericardial space. The mediastinum is the region between the pleural sacs, containing the heart and all of the thoracic viscera except the lungs. Drainage of fluid, or blood from the pericardial space after OHS is necessary to prevent complications as pericardium effusions and cardiac tamponade. It also helps to detect hemorrhage. Therefore, negative pressure drain is placed in the mediastinum .
Cardiac tamponade may occur after OHS as a result of blood or fluid collecting in the pericardial space compressing the heart and reducing cardiac output. However, mediastinal chest drain removal (MCDR) is a standardized potentially painful procedure that is commonly associated with pain and can be the worst hospital experience for those patients. MCDP after OHS is traditionally achieved using large-bore (28-36 Fr) plastic chest tubes for the first 24 hours after surgery or until drainage is minimal. MCDR reduces pain and improves the forced expiratory volume in one second. Therefore, it can improve the patients' fast recovery.
Separation of the drain from the adjoined tissues is painful as it adheres to the surrounding tissues. Sternal pain is a prevalent complication caused by CABG, which normally initiates within a few hours after surgery, and with poor control it is likely to predispose the patients to chronic pains lasting for six months to one year postoperatively.
The most disturbing complaint after OHS is acute pain, which is still a severe and under-treated problem. Moreover, MCDR is described as the worst pain experienced during the first 48 hours, which are spent in the ICU. Sternal pain may occur due to changing positions, coughing, deep breathing, use of a spirometer and movement in bed.
As being the fifth vital sign, pain is one of the most important factors causing physical and psychological discomfort to patients in the ICU. It induces physiological changes in most organ systems (WHO, 2011). Pain is a common symptom that increases patients' suffering and prolongs their hospital stay. This can delay their recovery time as the physiologic responses to pain inhibit the body's ability to react positively during the healing process.
Pain in ICU patients can contribute to unfavorable outcomes. The stress response to pain may cause hyperglycemia and increase catecholamine, cortisol, and antidiuretic hormone secretions. In addition, pain-induced reflex responses may alter respiratory mechanics, increase cardiac demands, and cause muscle spasms, rigidity, and contraction of skeletal muscles. There are many available pain assessment tools. These tools are used according to the patient's condition. If the patient is conscious and able to self-report pain, a visual analog scale and numerical rating scale can be used . For unconscious patients; a behavioral pain scale or the critical care observation tool can be used.
Pain management aims to alleviate pain or reduce it to an acceptable level. It includes two main basic approaches: pharmacological and non-pharmacological measures. Pharmacologic pain management refers to the use of medications as narcotics and non-narcotics analgesics. These medications control pain effectively but may be associated with many physical and psychological side effects. Additionally, the risk of drug dependency is high and the drugs are expensive. Moreover, using analgesics is the most common method to alleviate the pain induced by MCDR, but the patient response to medication can vary and may not achieve complete relaxation.
While non-pharmacological pain management measures include local anesthesia and complementary therapy. A combination of pharmacological and non-pharmacological approaches is reported to achieve the highest level of pain control with the least complications. Complementary therapy includes relaxation, touch therapy, music therapy, imagination, self-management, social support, and applying hot and cold therapy.
New modalities such as reflexology and cryotherapy can be used to deal with patients' pain, stress, and anxiety. These methods are simple, less expensive, non-invasive, and with fewer side effects. Reflexology is one of the most common complementary therapy used to produce stimulations on the referred reflexology areas. It is a systematic technique of applying pressure to particular points on the feet and hands to impact the health of related parts of the body. Each pressure point acts as a sensor that is linked with specific parts of the body. There are reflex points or zones in the feet correlated with all body parts. These zones form a chart of the body in the feet. Hence, when a specific reflex area is excited, the cells of the body comply by creating a reflex effect on the corresponding organs, nerves, tissues, and muscles.
Foot reflexology has been found to have the greatest impact on patients after cardiac surgery. It reduces tension, relieves fatigue, improves sleep and recovery time. It also reduces pain levels in patients following cardiac surgery. Evidence shows that reflexology massage is a simple and cost-effective technique. Moreover, it is considered a non-invasive method used to regulate the activity of the autonomic nervous system, coordinate physiological responses, alleviate anxiety, and induce relaxation.
- Conditions
- Foot Reflexology
- Being tested
- foot reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
Warm-Up Phase:
Pre-reflexology foot massage and all-over foot squeeze will be performed for two minutes.
Mini-Reflexology Session:
Specific reflexology will be performed with special attention to two important foot reflex areas that include:
Diaphragm and Solar Plexus Reflex Areas are located in the distance between the upper and middle third of the sole.
The Heart and Lung Reflex Areas are located below the chest of the foot. The heart pumps the oxygen-rich blood around the body
| Study group | Role | What they receive |
|---|---|---|
| foot reflexology group | Experimental | Patients who will receive foot reflexology before and throughout the MCDR procedure. Receives: Other: foot reflexology |
| control group | No intervention | Patients who will receive the routine ICU care during the MCDR procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of foot reflexology on pain
Incidence of pain during chest drain removal. Pain assessed by NRS [The scoring system is interpreted as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain] and CPOT scale [This pain assessment tool evaluates four clinical components: facial expressions, body movements, muscle tension, and compliance with the ventilator for mechanically ventilated patients or vocalization for the non-intubated patients. The CPOT score ranges from 2 to 8 and a score of more than 2 require pain management].
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot ReflexologyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, afnan attia ibrahim mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631522
- Sponsor's protocol ID
- P.0235
- Status last verified
- Nov 2022
- First submitted
- 26 May 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology on Pain Severity Associated With Mediastinal Chest Drain Removal in Patients Undergoing Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT05631522
- Acronym / sponsor ID
- P.0235
- Conditions
- Foot Reflexology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 30 Nov 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.
Cardiovascular diseases (CVDs) remain the leading cause of death worldwide and significantly affect patient quality of life and socioeconomic status. The care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. The burden of CVD and the high prevalence of CVD risk factors in Egypt are alarming.
Despite great evidence of adverse clinical impact, the pain remains infrequently assessed and poorly managed in ICU. Pain has serious physical and psychological effects which can impair patient recovery and discharge. Moreover, it does not allow the patients to collaborate appropriately during care-related procedures, such as mobilization and respiratory therapy.
Detailed description
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is commonly associated with an increased risk of blood clots and build-up of fatty deposits inside the arteries. CVD is the leading global cause of death accounting for more than 17.9 million deaths per year in 2019, representing 32% of all global deaths. Of these deaths, 85% were due to heart attack and stroke (World Health Organization [WHO], 2021). Mortality rate due to CVD is expected to grow to more than 23.6 million by 2030 (American Heart Association [AHA], 2017). In Egypt, the CVD mortality rate accounts for 46% of total deaths from all ages for both sexes (WHO, 2014).
There are many options for treating CVD, one of these options is open-heart surgery (OHS) especially coronary artery bypass graft (CABG) and valvular surgeries. CABG is done in patients with severe narrowing of the coronary arteries that do not respond to other treatment. Patients after OHS are usually transferred to the intensive care unit (ICU) to receive advanced medical care and close monitoring. They may suffer pain after OHS for various reasons including sternum incision, tissue excision, removal of saphenous vein, and the presence of chest drain as well as various factors related to the type of operation). Patients in the ICU are also exposed to many invasive and noninvasive painful procedures for diagnostic or therapeutic purposes.
Mediastinal chest drain placement (MCDP) and removal is one of these painful procedures. MCDP is a part from the standard care in cardiac surgery to assist the clearance of blood from the pericardial space. The mediastinum is the region between the pleural sacs, containing the heart and all of the thoracic viscera except the lungs. Drainage of fluid, or blood from the pericardial space after OHS is necessary to prevent complications as pericardium effusions and cardiac tamponade. It also helps to detect hemorrhage. Therefore, negative pressure drain is placed in the mediastinum .
Cardiac tamponade may occur after OHS as a result of blood or fluid collecting in the pericardial space compressing the heart and reducing cardiac output. However, mediastinal chest drain removal (MCDR) is a standardized potentially painful procedure that is commonly associated with pain and can be the worst hospital experience for those patients. MCDP after OHS is traditionally achieved using large-bore (28-36 Fr) plastic chest tubes for the first 24 hours after surgery or until drainage is minimal. MCDR reduces pain and improves the forced expiratory volume in one second. Therefore, it can improve the patients' fast recovery.
Separation of the drain from the adjoined tissues is painful as it adheres to the surrounding tissues. Sternal pain is a prevalent complication caused by CABG, which normally initiates within a few hours after surgery, and with poor control it is likely to predispose the patients to chronic pains lasting for six months to one year postoperatively.
The most disturbing complaint after OHS is acute pain, which is still a severe and under-treated problem. Moreover, MCDR is described as the worst pain experienced during the first 48 hours, which are spent in the ICU. Sternal pain may occur due to changing positions, coughing, deep breathing, use of a spirometer and movement in bed.
As being the fifth vital sign, pain is one of the most important factors causing physical and psychological discomfort to patients in the ICU. It induces physiological changes in most organ systems (WHO, 2011). Pain is a common symptom that increases patients' suffering and prolongs their hospital stay. This can delay their recovery time as the physiologic responses to pain inhibit the body's ability to react positively during the healing process.
Pain in ICU patients can contribute to unfavorable outcomes. The stress response to pain may cause hyperglycemia and increase catecholamine, cortisol, and antidiuretic hormone secretions. In addition, pain-induced reflex responses may alter respiratory mechanics, increase cardiac demands, and cause muscle spasms, rigidity, and contraction of skeletal muscles. There are many available pain assessment tools. These tools are used according to the patient's condition. If the patient is conscious and able to self-report pain, a visual analog scale and numerical rating scale can be used . For unconscious patients; a behavioral pain scale or the critical care observation tool can be used.
Pain management aims to alleviate pain or reduce it to an acceptable level. It includes two main basic approaches: pharmacological and non-pharmacological measures. Pharmacologic pain management refers to the use of medications as narcotics and non-narcotics analgesics. These medications control pain effectively but may be associated with many physical and psychological side effects. Additionally, the risk of drug dependency is high and the drugs are expensive. Moreover, using analgesics is the most common method to alleviate the pain induced by MCDR, but the patient response to medication can vary and may not achieve complete relaxation.
While non-pharmacological pain management measures include local anesthesia and complementary therapy. A combination of pharmacological and non-pharmacological approaches is reported to achieve the highest level of pain control with the least complications. Complementary therapy includes relaxation, touch therapy, music therapy, imagination, self-management, social support, and applying hot and cold therapy.
New modalities such as reflexology and cryotherapy can be used to deal with patients' pain, stress, and anxiety. These methods are simple, less expensive, non-invasive, and with fewer side effects. Reflexology is one of the most common complementary therapy used to produce stimulations on the referred reflexology areas. It is a systematic technique of applying pressure to particular points on the feet and hands to impact the health of related parts of the body. Each pressure point acts as a sensor that is linked with specific parts of the body. There are reflex points or zones in the feet correlated with all body parts. These zones form a chart of the body in the feet. Hence, when a specific reflex area is excited, the cells of the body comply by creating a reflex effect on the corresponding organs, nerves, tissues, and muscles.
Foot reflexology has been found to have the greatest impact on patients after cardiac surgery. It reduces tension, relieves fatigue, improves sleep and recovery time. It also reduces pain levels in patients following cardiac surgery. Evidence shows that reflexology massage is a simple and cost-effective technique. Moreover, it is considered a non-invasive method used to regulate the activity of the autonomic nervous system, coordinate physiological responses, alleviate anxiety, and induce relaxation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foot reflexology group | Experimental | Other: foot reflexologyPatients who will receive foot reflexology before and throughout the MCDR procedure. |
| control group | No intervention | –Patients who will receive the routine ICU care during the MCDR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult conscious patients ≥ 18 years old after OHS, who have a mediastinal chest drain.
- Gender: male and female
Key exclusion criteria (2 listed)
- 1. Sedated patients 2. Patients with any problem in the foot as a wound, allergy, injury, pain, callus, corn, fungal skin infection, or previous scars.
- 3. Patients use analgesics for 6 hours before the intervention.
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 reflexologyWarm-Up Phase: Pre-reflexology foot massage and all-over foot squeeze will be performed for two minutes. Mini-Reflexology Session: Specific reflexology will be performed with special attention to two important foot reflex areas that include: Diaphragm and Solar Plexus Reflex Areas are located in the distance between the upper and middle third of the sole. The Heart and Lung Reflex Areas are located below the chest of the foot. The heart pumps the oxygen-rich blood around the body | Other | foot reflexology group |
Primary outcome
Efficacy of foot reflexology on pain
Time frame: 1 day
Incidence of pain during chest drain removal. Pain assessed by NRS [The scoring system is interpreted as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain] and CPOT scale [This pain assessment tool evaluates four clinical components: facial expressions, body movements, muscle tension, and compliance with the ventilator for mechanically ventilated patients or vocalization for the non-intubated patients. The CPOT score ranges from 2 to 8 and a score of more than 2 require pain management].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology in people with Foot Reflexology, run by Mansoura University.
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 2 inclusion and 2 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Efficacy of foot reflexology on pain (time frame: 1 day). 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 30 Nov 2022.