Back to resultsThe Effect of Acupressure on the Anxiety Level (Acupres)
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Acupressure, Nursing students, Anxiety, COVID-19
Eligibility Criteria
Inclusion Criteria:
The experimental group criteria to be included in the study;
- To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
- Not having physical problems that would prevent acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
- Not having experience with acupressure,
- Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
- Not using alcohol and drugs,
- Not having access to the devices required for internet and online education,
- Not being diagnosed with COVID-19 during the study,
- Not having any psychiatric diagnosis.,
The control group criteria to be included in the study;
- To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
- Not having experience with acupressure,
- Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
- Not having access to the devices required for internet and online education,
- Not using alcohol and drugs,
- Not being diagnosed with COVID-19 during the study,
- Not having any psychiatric diagnosis
Exclusion Criteria:
The experimental group criteria not to be included in the study;
- Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
- Having a physical problem that prevents acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
- To have an acupressure experience,
- Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
- Having access to the devices required for internet and online education,
- Using alcohol and substance,
- Being diagnosed with COVID-19 during the study,
- Any psychiatric diagnosis
The control group criteria not to be included in the study;
- Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
- To have an acupressure experience,
- Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
- Having access to the devices required for internet and online education,
- Using alcohol and substance,
- Being diagnosed with COVID-19 during the study,
- Having any psychiatric diagnosis.
Sites / Locations
- Turkey, Mersin University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Before the intervention, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. After rubbing, each individual's pain threshold level will be taken as a basis in order not to cause tissue damage. The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes. In the study group, an average of 13 minutes will be applied to HT7, LI4 and EX-HN3 points (five points in total) for two minutes each. The nursing students participating in the research will be given a total of 12 acupressure intervention remotely, three days a week, for four weeks, at least two hours after dinner and when they are calmest.
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
Outcomes
Primary Outcome Measures
Anxiety evaluated using the State Anxiety Scale
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
Secondary Outcome Measures
Anxiety evaluated using the Trait Anxiety Scale
In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher trait anxiety scores indicate that anxiety level is also high.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04849793
Brief Title
The Effect of Acupressure on the Anxiety Level
Acronym
Acupres
Official Title
The Effect of Acupressure on the Anxiety Level of Senior Nursing Students in the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled study evaluates the effect of acupressure application on the anxiety level of senior nursing students.The hypothesis of this study is that acupressure reduces anxiety levels.
Detailed Description
Methods: In the study, 52 senior nursing students were randomly assigned to the study and control groups. The study group (n = 26) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the thumb and the LI4 points located in the space between the index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) will be applied for an average of 10 minutes. No intervention will be made to the control group (n = 26). In order to avoid ethical problems, both groups will be given an informative training on acupressure and anxiety content at the end of the study. The primary outcome of the study is the effect of acupressure on the state anxiety level of senior nursing students. The secondary outcome of the study is the effect of acupressure on trait anxiety level in senior nursing students. The results will be collected before the acupressure and in the 4th week of the last intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Acupressure, Nursing students, Anxiety, COVID-19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, two-arm randomized controlled clinical trial
Masking
Participant
Masking Description
First of all, the names of all students will be listed alphabetically for the selection of 196 nursing students in the research population and 52 nursing students who will be the sample. Numbers between 1-196 will be written in front of each student in the ordered student list. 52 nursing students will be determined by randomization created in computer environment by an independent researcher who is not included in the study. A total of 52 students in the sample group determined by randomization will be separated according to the A and B groups created by the same statistician in computer environment.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Before the intervention, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. After rubbing, each individual's pain threshold level will be taken as a basis in order not to cause tissue damage. The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes. In the study group, an average of 13 minutes will be applied to HT7, LI4 and EX-HN3 points (five points in total) for two minutes each. The nursing students participating in the research will be given a total of 12 acupressure intervention remotely, three days a week, for four weeks, at least two hours after dinner and when they are calmest.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
Acupress
Intervention Description
Before starting the application, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. . The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes
Primary Outcome Measure Information:
Title
Anxiety evaluated using the State Anxiety Scale
Description
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
Time Frame
Change from before implementation and 4th week of practice
Secondary Outcome Measure Information:
Title
Anxiety evaluated using the Trait Anxiety Scale
Description
In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher trait anxiety scores indicate that anxiety level is also high.
Time Frame
Change from before implementation and 4th week of practice
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The experimental group criteria to be included in the study;
To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
Not having physical problems that would prevent acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
Not having experience with acupressure,
Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
Not using alcohol and drugs,
Not having access to the devices required for internet and online education,
Not being diagnosed with COVID-19 during the study,
Not having any psychiatric diagnosis.,
The control group criteria to be included in the study;
To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
Not having experience with acupressure,
Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
Not having access to the devices required for internet and online education,
Not using alcohol and drugs,
Not being diagnosed with COVID-19 during the study,
Not having any psychiatric diagnosis
Exclusion Criteria:
The experimental group criteria not to be included in the study;
Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
Having a physical problem that prevents acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
To have an acupressure experience,
Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
Having access to the devices required for internet and online education,
Using alcohol and substance,
Being diagnosed with COVID-19 during the study,
Any psychiatric diagnosis
The control group criteria not to be included in the study;
Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
To have an acupressure experience,
Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
Having access to the devices required for internet and online education,
Using alcohol and substance,
Being diagnosed with COVID-19 during the study,
Having any psychiatric diagnosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülay ALTUN UĞRAŞ, Doctorate
Organizational Affiliation
gulaltun@mersin.edu.tr
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seher GÜRDİL YILMAZ, Doctorate
Organizational Affiliation
shrgrdl@hotmail.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmet KARAMAN, Doctorate
Organizational Affiliation
ahmet.karaman@mersin.edu.tr
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Canan KANAT, MASTER
Organizational Affiliation
canankanat@mersin.edu.tr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turkey, Mersin University,
City
Mersin
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Acupressure on the Anxiety Level
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