Clinical trial NCT04956055: The Effect of Hand Reflexology on Anxiety and Vital Signs With Angiography
Official title: The Effect of Hand Reflexology on Anxiety and Vital Signs in Patients With Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Keywords: anxiety
life findings
coronary angiography
distress
reflexology
angiography
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled trial
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Demographic form
timeFrame: 15 July 2021-15 October 2021three months (face to face interview)
Secondary outcomes:
measure: Distress thermometer:
timeFrame: 15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to distress
Other outcomes:
measure: Vital signs
timeFrame: 15 July 2021-15 October 2021 three months (fever-centigrade, respiration per minute, blood pressure mmHg)
measure: State anxiety inventory
timeFrame: 15 July 2021-15 October 2021 5 minute (face to face interview) patient mark statement and give score
measure: Visual Analog Scale
timeFrame: 15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to pain
Locations:
city: Kocaeli
country: Turkey
facility: Gebze Fatih Hospital
Study officials:
affiliation: Marmara University
name: Hatice Karabuga Yakar
role: STUDY_DIRECTOR
References: