The Effect of Hand Reflexology on Anxiety and Vital Signs With Angiography

NCT ID: NCT04956055

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-01-15

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.

Conditions

Coronary Artery Disease; Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experiment group

Experimental group to be applied hand reflexology

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: OTHER

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.

Control group

experimental group for which hand reflexology will not be applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reflexology

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hatice Karabuga Yakar

Role: STUDY_DIRECTOR

Marmara University

Locations

Gebze Fatih Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Hatice Karabuga Yakar, PhD

Role: CONTACT

hatice.karabuga@gmail.com

905356895745

Habibe Engin, RN

Role: CONTACT

hemsire3505@gmail.com

905382032517

Other Identifiers

16.03.2020-35

Identifier Type: -

Identifier Source: org_study_id