Clinical trial NCT04849793: The Effect of Acupressure on the Anxiety Level
Official title: The Effect of Acupressure on the Anxiety Level of Senior Nursing Students in the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Acupressure
Nursing students
Anxiety
COVID-19
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two-arm randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from before implementation and 4th week of practice
Secondary outcomes:
measure: Anxiety evaluated using the Trait Anxiety Scale
timeFrame: Change from before implementation and 4th week of practice
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University,
Study officials:
affiliation: gulaltun@mersin.edu.tr
name: Gülay ALTUN UĞRAŞ, Doctorate
role: STUDY_DIRECTOR
affiliation: shrgrdl@hotmail.com
name: Seher GÜRDİL YILMAZ, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: ahmet.karaman@mersin.edu.tr
name: Ahmet KARAMAN, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: canankanat@mersin.edu.tr
name: Canan KANAT, MASTER
role: PRINCIPAL_INVESTIGATOR
References: