AnxietyAcupresNCT04849793

The Effect of Acupressure on the Anxiety Level

A study testing Acupressure in people with Anxiety, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety
What is being tested?: Acupressure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Apr 2021to 15 May 2021
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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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,

Show all 17Show fewer

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

Who cannot join

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,

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Turkey, Mersin University,
Mersin

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acupressure on the Anxiety Level of Senior Nursing Students in the COVID-19 Pandemic

Read the 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.

Conditions: Anxiety
Being tested: Acupressure
Keywords: Acupressure, Nursing students, Anxiety, COVID-19
Medical subject headings: Anxiety Disorders, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupressureOther
Also called Acupress
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

Study groups in NCT04849793
Study group	Role	What they receive
Experimental	Experimental	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. Receives: Other: Acupressure
Control	No intervention	No intervention will be made to the control group, only the data will be collected at the same time as the study group.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Change from before implementation and 4th week of practice

Secondary outcomes (1)

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.
Measured: Change from before implementation and 4th week of practice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202115 May 2021

First posted19 Apr 2021
Study start15 Apr 2021
Primary completion15 May 2021
Study completion15 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Mersin 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, parallel, two-arm randomized controlled clinical trial
Masking: Single blind
Who is masked: Participant
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849793
Sponsor's protocol ID: MersinUniversity
Acronym: Acupres
Status last verified: Nov 2022
First submitted: 8 Apr 2021
Last updated: 14 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Acupressure on the Anxiety Level of Senior Nursing Students in the COVID-19 Pandemic
ClinicalTrials.gov ID: NCT04849793
Acronym / sponsor ID: Acupres / MersinUniversity
Conditions: Anxiety
Keywords: Acupressure, Nursing students, Anxiety, COVID-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Mersin UniversityUniversity, hospital or other
Study start: 15 Apr 2021 (actual)
Primary completion: 15 May 2021 (actual)
Study completion: 15 May 2021 (actual)
First posted: 19 Apr 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Prospective, parallel, two-arm randomized controlled clinical trial

Arm	Type	Receives
Experimental	Experimental	Other: AcupressureBefore 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.
Control	No intervention	–No intervention will be made to the control group, only the data will be collected at the same time as the study group.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

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.),

Key exclusion criteria (17 listed)

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.),

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
AcupressureAlso: AcupressBefore 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	Other	Experimental

Primary outcome

Anxiety evaluated using the State Anxiety Scale
Time frame: Change from before implementation and 4th week of practice
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

1 secondary outcome

Anxiety evaluated using the Trait Anxiety Scale
Time frame: Change from before implementation and 4th week of practice

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Individual participant dataSharing planned: No

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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.

Gülay ALTUN UĞRAŞ, Doctorate study director

gulaltun@mersin.edu.tr

Seher GÜRDİL YILMAZ, Doctorate principal investigator

shrgrdl@hotmail.com

Ahmet KARAMAN, Doctorate principal investigator

ahmet.karaman@mersin.edu.tr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure in people with Anxiety, run by Mersin 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 17 inclusion and 17 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: finished, as of the sponsor's last update on 14 Nov 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety evaluated using the State Anxiety Scale (time frame: Change from before implementation and 4th week of practice). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849793.

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 14 Nov 2022.