Protocol summary

Summary
The aim of this study was to determine the effect of acupressure on quality of life and symptoms of early menopause in women. In this study, eligible individuals of Yasouj all healthy women with health records selected and randomly divided into 4 groups (including Hugo acupressure, acupressure at Sanyinjiao point and the two groups false acupressure points) were divided .Of the four health centers in Yasouj two centers were selected randomly And then centers based on the number of health care records 50 samples randomly Using a random numbers table if the initial inclusion criteria were selected to achieve the desired sample size. Finally, 160 healthy postmenopausal women were enrolled. The main inclusion criteria: start 5-1 years of menopause, people with average quality of life score (52-26) and poor quality of life (87-52), the exclusion criteria: unwillingness to participate or continue to participate in the study, developing the diseases that have affected the outcome variable. Intervention for 4 weeks was just a day of rest. The purpose of the intervention was determined by the first pressure point, then the pressure of a pump and then pump behavior decompression was performed and the process for 30 minutes (15 minutes and 15 minutes resting pressure) to be repeated as. Baseline questionnaires, 2 weeks and 4 weeks after the intervention was completed by the participants. Quality of life score and menopausal symptoms in four groups and each group was compared before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052022347N1
Registration date: 2016-04-05, 1395/01/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-05, 1395/01/17
Registrant information
Name
Masoome Davoodi
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 4737
Email address
m.davoodi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Yasuj University of Medical Science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials acupressure points Sanyinjiao and Hugo and false points of acupressure on quality of life and symptoms in postmenopausal women
Public title
Acupressure effect on quality of life and symptoms of menopause
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: experiencing a normal menopause without surgery and medical intervention, lack of participation background in acupressure, 1 to 5 years should have been passed since the start of menopause, people with average quality of life score (52 -26) and poor quality of life (87-52). Exclusion criteria: The unwillingness to participate or continue to participate in the study, moving from the place of the study, suffering from diseases that affect the variables of consequence.
Age
From 48 years old to 58 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Science
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Approval date
2014-07-28, 1393/05/06
Ethics committee reference number
93.05.06.06

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
n95.1
ICD-10 code description
Symptoms such as hot flashes, insomnia, headaches, lack of concentration, associated with menopause

Primary outcomes

1

Description
symptoms of menopause
Timepoint
Before the intervention, two weeks after the intervention, four weeks after the intervention
Method of measurement
Kuperman questionnaire

2

Description
Quality of life
Timepoint
Before the intervention, two weeks after the intervention, four weeks after the intervention
Method of measurement
General Quality of Life Questionnaire sf12, Menopause Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Do acupressure in the Sanyinjiao point: In this group put pressure on the inside of the leg above the Wrist for 4 weeks as every other day for 30 minutes (15 minutes and 15 minutes resting pressure) was done
Category
Rehabilitation

2

Description
Do acupressure in Hugo false point: in this group one and a half inches from the point that Hugo was not in the main meridians, just back and touch the skin and the pressure was not applied.
Category
Rehabilitation

3

Description
Do acupressure in Sanyinjiao false point: in this group one and a half inches of Sanyinjiao point that was not in the main meridians, and touch only contact with the skin and the pressure was not applied.
Category
Rehabilitation

4

Description
Do acupressure in Hugo point: In this group put pressure on the back of hand bone in the angle between thumb and forefinger for 4 weeks every other day for 30 minutes each day (15 minutes of pressure and a 15-minute rest) Been.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dastgheyb Health Center
Full name of responsible person
Masoome Davoodi
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj

2

Recruitment center
Name of recruitment center
Health Center Sharaf Abad
Full name of responsible person
Masoome Davoodi
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Yasuj University of Medical Science
Full name of responsible person
Mahmood Naraki
Street address
Vice Chancellor for Research of Yasuj University of Medical Science, ground floor, Center Building of Yasuj University of Medical Sience, Setad, Shahid Motahari Boulevard, Yasuj.
City
Yasuj
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 of Yasuj University of Medical Science
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
Yasuj university of Medical Science
Full name of responsible person
Masoome Davoodi
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 3333 4737
Fax
+98 74 1333 7370
Email
davodi.ma@ymail.com www.yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr. Ardashir Afrasyabifar
Position
PHD in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 3223 4115
Fax
+98 74 1333 7370
Email
afrasiabifar@yahoo.com- afrasiabifar.ardashir@Yums.ac.ir - www.yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Masoome Davoodi
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 3333 4737
Fax
+98 74 1333 7370
Email
davodi.ma@ymail.com www.yums.ac.ir
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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