Coronary Artery DiseaseNCT04956055
The Effect of Hand Reflexology on Anxiety and Vital Signs With Angiography
A study testing Reflexology in people with Coronary Artery Disease and Coronary Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of hand reflexology on anxiety and vital signs in patients undergoing coronary angiography. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 15 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be applied coronary angiography for the first time waiting for coronary angiography on the same day,
- Patients over the age of 18,
- Physically and mentally patients have the ability to fill forms,
- Patients who will undergo femoral angiography, that patients agree to participate in research
Who cannot join
- Patients who do not accept the study,
- Who are physically and mentally unable to fill the forms,
- Who have sudden changes in vital signs,
- Who do not voluntarily continue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hand Reflexology on Anxiety and Vital Signs in Patients With Coronary Angiography
This study was planned to determine the effect of hand reflexology on anxiety and vital signs in patients undergoing coronary angiography. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Since the study is a single-blind randomized clinical trial, in order to determine the randomization , a box with the names of the patients determined according to the participation criteria will be determined by the selection of the healthcare personnel responsible for the service, and the experimental and control groups. "Demographic Data Form" , "Distress Thermometer". "State Anxiety Inventory" , "Vital Signs Form" and Visual Analog Scale will be used to collect research data.
Read the detailed description
Reflexology is a technique of pressure or pressure that is applied manually to the special points of the hand, foot and sometimes ear areas. Reflexology is applied to the soles of the hands and feet, its circumference, surface, inner and outer edges and the ear area The most important differences that distinguish reflexology from other applied therapies are; It is a healing therapy method that provides the balance strength of the body and stimulates the body's self-healing mechanism. Every part of the body has a counterpart in the hands and feet. Accordingly, reflexology to the hands and feet makes it easier to solve the problem in patients and patients. It is an easy-to-apply, no-material, medicine-assisted therapy method. Since reflexology is a method of compression and pressure, the presses on the hand reduce the stimulation of the parasympathetic and sympathetic nervous system. In the meantime, it improves blood circulation in the patient and helps one to feel peaceful and well-being. Anxiety prior to coronary angiography may lead to changes in life findings such as hypertension in patients, increased blood sugar, increased heart rate, tremor, sweating. In many studies conducted in the world and in our country related to reflexology, it was observed that the patients in the experimental group decreased their anxiety levels, breath rates, heart rates, blood pressures, milk amount of mothers and pain levels.
Inspired by these studies, the Ministry of Health of the Republic of Turkey, on the newly developing hand reflexology in our country. At the Hospital, it will be the first time to be coronary angiography for the coronary angiography, and for the first time, only femoral angiography, which is capable of filling the forms physically and mentally, without invasive procedures related to the heart. A total of 60 patients constitute the sample of the study, provided that it is planned and to accept the study. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Since the study is a single-blind randomized clinical trial, in order to determine the randomization , a box with the names of the patients determined according to the participation criteria will be determined by the selection of the healthcare personnel responsible for the service, and the experimental and control groups. "Demographic Data Form" , "Distress Thermometer" "State Anxiety Inventory" , "Vital Signs Form" and Visual Analog Scale will be used to collect research data. The data will be taken face to face from patients who will participate in the study. The data collected from the sample group will be analyzed in program. Frequency values will be calculated to determine the distribution of categorical data, and chi-square analysis will be done and burr tables will be created. When comparing the averages of parameters containing more than two variables, variance analysis (anova) will be used and Tukey test results will be taken into consideration for significance. In repeated measurements, two-way analysis of variance (two way anova) will be used. If the research data are not normally distributed, analysis will be carried out using nonparametric tests. In this context, tests such as mann whitney u test, wilcoxon test and kruskal Wallis variance analysis will be used. In addition, the significance value of p will be considered as 0.5 for the research results to be in the 95% confidence interval .
There are not enough studies done with hand reflexology in the world and in our country. As it is an easy-to-apply, material-free therapy that can be performed under favorable conditions, it can be used to reduce anxiety before coronary angiography, to minimize stress levels and to keep changing life signs stable. Thanks to reflexology, anxiety status of the patient can be taken under control by using the internal energy of the patient without any side effects. Since reflexology is a therapy method that can be used in a wide range and shows its effect immediately, it is a method that can be used and beneficial in the field of nursing.
- Conditions
- Coronary Artery Disease, Coronary Disease
- Being tested
- Reflexology
- Keywords
- anxiety, life findings, coronary angiography, distress, reflexology, angiography
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
The patient will be kept in a lying position. First, the patient will be given four minutes of hand reflexology on each hand with warming and stimulation techniques.Reflexology will be applied to the left hand with the thumb of the right hand, the thumb of the left hand and the special points in the right hand. It will be applied to the fingers, palm, back of the hand, and finally the wrists, respectively, starting with the fingertips and using special reflexology techniques (a total of six minutes for each hand separately). By sending a moderate stimulus, a total of 20 minutes of reflexology session will continue.Since the patient reveals and uses his own internal energy at the end of the session, nobody should talk to the patient until five minutes after the procedure. Survey questions and vital signs would be examined five minutes after the session and the research with the participant would end.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | Experimental group to be applied hand reflexology Receives: Other: Reflexology |
| Control group | No intervention | experimental group for which hand reflexology will not be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic form
This form created by the researcher includes the patient's age, gender, marital status, smoking and alcohol use status, job, education level, country of origin, chronic illness, reason for angiography.
Measured: 15 July 2021-15 October 2021three months (face to face interview)
Secondary outcomes (1)
Distress thermometer:
It was developed by Roth et al in 1998 to determine the psychosocial distress of cancer patients.In the distress thermometer, it determines the distress level of the patient between 1 and 10 numerically.It is a simple visual scale that patients can answer even on their own.The participant expresses the distress he experiences by means of the numbers on this thermometer. 0 points indicate that the individual does not experience any distress, and 10 points indicates that the individual experiences distress at the upper limit. Distress thermometer validity and reliability study in our country in 2006. In the study, the sensitivity of the scale was 0.73 and the specificity was 0.49. In the study conducted in our country cut-off point of the scale was found to be 4.
Measured: 15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to distress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Karabuga Yakar, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956055
- Sponsor's protocol ID
- 16.03.2020-35
- Status last verified
- Jan 2021
- First submitted
- 28 Mar 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Reflexology on Anxiety and Vital Signs in Patients With Coronary Angiography
- ClinicalTrials.gov ID
- NCT04956055
- Acronym / sponsor ID
- 16.03.2020-35
- Conditions
- Coronary Artery Disease, Coronary Disease
- Keywords
- anxiety, life findings, coronary angiography, distress, reflexology, angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 9 Jul 2021 (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 study was planned to determine the effect of hand reflexology on anxiety and vital signs in patients undergoing coronary angiography. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Since the study is a single-blind randomized clinical trial, in order to determine the randomization , a box with the names of the patients determined according to the participation criteria will be determined by the selection of the healthcare personnel responsible for the service, and the experimental and control groups. "Demographic Data Form" , "Distress Thermometer". "State Anxiety Inventory" , "Vital Signs Form" and Visual Analog Scale will be used to collect research data.
Detailed description
Reflexology is a technique of pressure or pressure that is applied manually to the special points of the hand, foot and sometimes ear areas. Reflexology is applied to the soles of the hands and feet, its circumference, surface, inner and outer edges and the ear area The most important differences that distinguish reflexology from other applied therapies are; It is a healing therapy method that provides the balance strength of the body and stimulates the body's self-healing mechanism. Every part of the body has a counterpart in the hands and feet. Accordingly, reflexology to the hands and feet makes it easier to solve the problem in patients and patients. It is an easy-to-apply, no-material, medicine-assisted therapy method. Since reflexology is a method of compression and pressure, the presses on the hand reduce the stimulation of the parasympathetic and sympathetic nervous system. In the meantime, it improves blood circulation in the patient and helps one to feel peaceful and well-being. Anxiety prior to coronary angiography may lead to changes in life findings such as hypertension in patients, increased blood sugar, increased heart rate, tremor, sweating. In many studies conducted in the world and in our country related to reflexology, it was observed that the patients in the experimental group decreased their anxiety levels, breath rates, heart rates, blood pressures, milk amount of mothers and pain levels.
Inspired by these studies, the Ministry of Health of the Republic of Turkey, on the newly developing hand reflexology in our country. At the Hospital, it will be the first time to be coronary angiography for the coronary angiography, and for the first time, only femoral angiography, which is capable of filling the forms physically and mentally, without invasive procedures related to the heart. A total of 60 patients constitute the sample of the study, provided that it is planned and to accept the study. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Since the study is a single-blind randomized clinical trial, in order to determine the randomization , a box with the names of the patients determined according to the participation criteria will be determined by the selection of the healthcare personnel responsible for the service, and the experimental and control groups. "Demographic Data Form" , "Distress Thermometer" "State Anxiety Inventory" , "Vital Signs Form" and Visual Analog Scale will be used to collect research data. The data will be taken face to face from patients who will participate in the study. The data collected from the sample group will be analyzed in program. Frequency values will be calculated to determine the distribution of categorical data, and chi-square analysis will be done and burr tables will be created. When comparing the averages of parameters containing more than two variables, variance analysis (anova) will be used and Tukey test results will be taken into consideration for significance. In repeated measurements, two-way analysis of variance (two way anova) will be used. If the research data are not normally distributed, analysis will be carried out using nonparametric tests. In this context, tests such as mann whitney u test, wilcoxon test and kruskal Wallis variance analysis will be used. In addition, the significance value of p will be considered as 0.5 for the research results to be in the 95% confidence interval .
There are not enough studies done with hand reflexology in the world and in our country. As it is an easy-to-apply, material-free therapy that can be performed under favorable conditions, it can be used to reduce anxiety before coronary angiography, to minimize stress levels and to keep changing life signs stable. Thanks to reflexology, anxiety status of the patient can be taken under control by using the internal energy of the patient without any side effects. Since reflexology is a therapy method that can be used in a wide range and shows its effect immediately, it is a method that can be used and beneficial in the field of nursing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: ReflexologyExperimental group to be applied hand reflexology |
| Control group | No intervention | –experimental group for which hand reflexology will not be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be applied coronary angiography for the first time waiting for coronary angiography on the same day,
- Patients over the age of 18,
- Physically and mentally patients have the ability to fill forms,
- Patients who will undergo femoral angiography, that patients agree to participate in research
Key exclusion criteria (4 listed)
- Patients who do not accept the study,
- Who are physically and mentally unable to fill the forms,
- Who have sudden changes in vital signs,
- Who do not voluntarily continue
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 |
|---|---|---|
| ReflexologyThe patient will be kept in a lying position. First, the patient will be given four minutes of hand reflexology on each hand with warming and stimulation techniques.Reflexology will be applied to the left hand with the thumb of the right hand, the thumb of the left hand and the special points in the right hand. It will be applied to the fingers, palm, back of the hand, and finally the wrists, respectively, starting with the fingertips and using special reflexology techniques (a total of six minutes for each hand separately). By sending a moderate stimulus, a total of 20 minutes of reflexology session will continue.Since the patient reveals and uses his own internal energy at the end of the session, nobody should talk to the patient until five minutes after the procedure. Survey questions and vital signs would be examined five minutes after the session and the research with the participant would end. | Other | Experiment group |
Primary outcome
Demographic form
Time frame: 15 July 2021-15 October 2021three months (face to face interview)
This form created by the researcher includes the patient's age, gender, marital status, smoking and alcohol use status, job, education level, country of origin, chronic illness, reason for angiography.
1 secondary outcome
Distress thermometer:
Time frame: 15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to distress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Hatice Karabuga Yakar study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Coronary Artery Disease and Coronary Disease, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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 9 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hatice Karabuga Yakar, PhD (905356895745, hatice.karabuga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic form (time frame: 15 July 2021-15 October 2021three months (face to face interview)). 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 9 Jul 2021.