1. Home
  2. Approved trials
  3. » فارسی

Comparison of the efficacy of two factors of acupressure and desirable Azkar on the patients’ anxiety before surgery

Protocol summary

Study aim
The efficacy of two factors of acupressure and desirable Azkar on the patients’ anxiety before surgery
Design
The study will be randomized controlled clinical trial on 150 people who were included in the study through simple sampling and randomly one of the three groups of acupressure, recommended azkar or control group
Settings and conduct
This study is a randomized controlled trial that will be performed to investigate and compare the effectiveness of two methods of acupressure and recommended remembrance on the anxiety of patients undergoing surgery in hospitals in Ferdows
Participants/Inclusion and exclusion criteria
Inclusion criteria: not having any special problems in the spot of receiving acupressure, not having any sight disorder that can prevent choosing the proper spot in the standard of anxiety examination, not receiving tranquilizers, painkillers, or drugs effective on anxiety such as Inderal for more than one month.Not having pain, epilepsy, or mental disorder, history of using acupressure, presence of thyroid diseases, addiction to drugs, pregnancy, previous surgery due to malignancy
Intervention groups
To apply acupressure, the third eye point (Yintang), which is located between the two eyes, will be pressed for about 10 minutes. In the desirable Azkar group, the research units will listen to Hamd and Zikr La hool and La qwat ela be llah several times using an audio source. In the control group, pressure will be applied for 10 minutes on the false point, which has no effect on the patient's sedation.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201026049149N1
Registration date: 2020-11-28, 1399/09/08
Registration timing: registered_while_recruiting

Last update: 2020-11-28, 1399/09/08
Update count: 0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Azade Araste
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 0117
Email address
azadearaste@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of two factors of acupressure and desirable Azkar on the patients’ anxiety before surgery
Public title
the efficacy of two factors of acupressure and desirable Azkar on the patients’ anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No special problems at the site of acupressure Do not take sedatives, such as Inderal analgesics for more than a month No pain, history of epilepsy or mental health problems No history of thyroid disease and taking drugs that affect it No drug addiction No visual disturbances
Exclusion criteria:
Reluctance to participate in the study
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 141
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done easily and 150 eligible patients will be included in the study and randomly divided into three groups of 50 (acupressure, recommended azkar, control).
Blinding (investigator's opinion)
Single blinded
Blinding description
In the control group, pressure will be applied for 10 minutes in a lying position that has no effect on patient sedation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Shahid Motahari St., Chamran Hospital
City
ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-07-03, 1399/04/13
Ethics committee reference number
IR.BUMS.REC.1399.136

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
anxiety
Timepoint
before, immediately after and 30 min after intervention
Method of measurement
scale for anxiety

2

Description
vital sign
Timepoint
before, immediately after and 30 min after intervention
Method of measurement
A mercury manometer to measure the blood pressure, clock for Heart and respiratory rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acupressure in the third eye (Yintang) between the two eyes for 10 minutes
Category
Prevention

2

Description
Intervention group: desirable Azkar
Category
Prevention

3

Description
Control group: Apply pressure for 10 minutes on the supine point, which has no effect on the patient's sedation
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Azade Araste
Street address
Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3272 0117
Email
azadearaste@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Birjand University of Medical Sciences › Research & Innovation
Street address
Shahid Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
esearch@bums.ac.ir
Web page address
http://rsh.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Azade Araste
Position
msc-Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3272 0117
Email
azadearaste@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
azade araste
Position
MSC Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3272 0117
Email
azadearaste@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
azade araste
Position
MSC
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3272 0117
Email
azadearaste@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data collected
When the data will become available and for how long
From the year 1400
To whom data/document is available
All researchers
Under which criteria data/document could be used
Legal use and with the permission of the researcher
From where data/document is obtainable
azadearaste@yahoo.com
What processes are involved for a request to access data/document
One day to a maximum of one week
Comments
Loading...