Protocol summary

Study aim
Evaluation of the effect of acupuncture on test anxiety
Design
A controlled clinical trial, with parallel groups, single-blind, randomized, on 114 medical students. Random blocking is used for randomization.
Settings and conduct
Acupressure has been proposed in the treatment of test anxiety today. This study is performed on medical students of Kermanshah. Samples will be divided into intervention and control groups (57 people in each group) based on random blocking. Participants are unaware of the type of allocation to intervention and control groups. The Shen Men point is used in the intervention group. This point is pressed in a circular, gentle, and uniform manner with the index finger for ten minutes. For the control group, an ineffective sham point is used and pressed in the same way as the intervention group. Before and after the intervention, the test anxiety questionnaire is completed by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: studying medicine; having an exam according to the approved program of the faculty. Exclusion criteria: history of mental illness; using psychotropic drugs (anti-anxiety and anti-depressant drugs) from one week before the study; having thyroid disease, and smoking.
Intervention groups
The groups include two groups of intervention and control. To apply acupressure in the intervention group, the Shen Men point is used, which is located in the upper wall of the ear cavity on the non-dominant side. This point is pressed in a circular, gentle, and uniform manner with the index finger for ten minutes. In the control group, the intervention is performed at the Sham point, which has no therapeutic effect. The location of this point is the outer corner of the left eyebrow and the beginning of the ear canal (non-dominant side).
Main outcome variables
Test anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100913004736N24
Registration date: 2022-01-12, 1400/10/22
Registration timing: prospective

Last update: 2022-01-12, 1400/10/22
Update count: 0
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on test anxiety in medical students
Public title
The effect of acupressure on test anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Studying medicine Having an exam based on the approved program of the faculty Willingness to participate in the study
Exclusion criteria:
Having a history of mental illness Use of psychotropic drugs (anti-anxiety and anti-depressant drugs) from one week before the study Having thyroid disease Smoking
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are randomly assigned to intervention and control groups. Randomization unit: individual Randomization tool: statistical software Blocks are generated by the software. Allocation concealment: The study is single-blind and participants are unaware of the assigned group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not know the type of group assigned.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti St.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.KUMS.MED.REC.1400.093

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Test anxiety
Timepoint
Before and after acupressure, test anxiety is measured using a questionnaire. Acupressure time is half an hour before the test.
Method of measurement
Sarason (1975) questionnaire is used to measure test anxiety.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Shen Men point is used which is located in the upper wall of the ear cavity on the non-dominant side. This point is pressed unilaterally, for ten minutes with the index finger in a circular, gentle, and uniform manner, by male or female researchers (according to the gender of the students). The samples are unaware of which group they belong to.
Category
Treatment - Other

2

Description
Control group: For the control group, the sham point is used in a similar way, which is located in the outer corner of the left eyebrow and at the beginning of the non-dominant side of the ear cavity. The study is a single-blind study, and the samples are unaware of which group they belong to.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Medicine
Full name of responsible person
Alireza Khatony
Street address
Nurse Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Shahid Beheshti St.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 6967
Fax
+98 83 3827 6967
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti St.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti St.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti St.
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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