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The synergistic effect of useing two pressure points p6 and third eye on preoperative anxiety in orthopedic patients of Iran University of Medical Sciences hospitals

Protocol summary

Summary
The purpose of this study was to investigate the synergistic effect of using two pressure points p6 and third eye on preoperative anxiety in orthopedic patients of Iran University of Medical Sciences hospitals.This was a single blind quasi-experimental controlled trial in 108 patients who were candidates orthopedic surgeries and didn't have epilepsy; taking anti-anxiety and sedative drugs; drug addiction; etc. The randomized design was divided into 4 groups (each group consisting of 27 patients), which included(p6) the first group, the second group, the third eye, the third group,(p6) and the third eye, and the fourth group, the control group. The method of applying acupressure in the intervention group, pressure is applied at the desired location for ten minutes with a thumb on the spot (P6) and by a small plastic bead at the third eye point, so that the patient feels pain and in the control group, only touch alone is performed without any compression in the areas (P6) and the third eye for ten minutes. Before intervention and half an hour after intervention, in 4 groups, the Absolute Anxiety Inventory of Spielberger will be completed by the patient.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091136126N1
Registration date: 2017-09-24, 1396/07/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
fariba keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 090 6205
Email address
keshavarz.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The synergistic effect of useing two pressure points p6 and third eye on preoperative anxiety in orthopedic patients of Iran University of Medical Sciences hospitals
Public title
The effect of useing two pressure points p6 and third eye on preoperative anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lack of skin disease in the area of acupressure; elective surgery (non-emergency procedures); lack of mental illness; no history of surgery; having at least a reading and writing literacy; at least 15 years of age and a maximum age of 65 Year. Exclusion criteria: history of epilepsy; anti-anxiety drugs and sedatives one week before participating in the study; drug addiction; having relatives among the medical staff.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower Tehran, Iran
City
tehran
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.IUMS.REC 1396.30212

Health conditions studied

1

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

Primary outcomes

1

Description
preoperative anxiety
Timepoint
before and 30 min after intervention
Method of measurement
spielburger questionnaire)

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, pressure is applied at the desired location for ten minutes with a thumb on the spot (P6) and by a small plastic bead at the third eye point, so that the patient feels pain.
Category
Prevention

2

Description
In the control group, only touch alone is performed without any compression in the areas (P6) and the third eye for ten minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences hospitals
Full name of responsible person
Fariba Keshavarz
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Keshavarz
Position
MSc operation room
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2558
Fax
Email
keshavarz71f@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Keshavarz
Position
MSc of operation room
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2558
Fax
Email
keshavarz71f@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Keshavarz
Position
MSc of operation room
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2558
Fax
Email
keshavarz71f@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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