Determining the effect of acupressure in two points; Sanyinjiao (Sp6) and Taichong (Liv 3) on improvement of women’s sexual function and quality of sexual life
Design
This study is a non-blind randomized clinical trial with a control group. The estimated sample size is 126 individuals divided into two intervention and control groups with four-block random allocation.
Settings and conduct
The research environment is the health care centers affiliated Tehran University of Medical Sciences. Women who eligible will be divided into groups; intervention and control with the four-block random allocation. The intervention group will conduct the acupressure on the Liv3 and Sp6 for 8 weeks. The control group will no intervention during the study. Sexual function and sexual quality of life questionnaires will be completed before, immediately and 4 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women with Being in the permanent and monogamous marital relationship Having at least level of reading and writing literacy.
Exclusion criteria: Having sexual dysfunction being in the treatment process Addiction to narcotic drugs and alcohol Her husband has sexual dysfunction Positive history of unpleasant psychological experiences in the past six months Being in the pregnancy, lactation, and menopause period Having psychological and physical well-known chronic disease that affect sexual function Using drugs that effect the sexual function
Intervention groups
The intervention group will conduct the acupressure on the Liv3 and Sp6 after the training for 8 weeks. The control group will no intervention during the study but after that, based on their willing the researcher will educate them.
Main outcome variables
Sexual function, Quality of sexual life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N8
Registration date:2019-09-08, 1398/06/17
Registration timing:registered_while_recruiting
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure in two points; Sanyinjiao (Sp6) and Taichong (Liv3) on improvement of women’s sexual function and quality of sexual life
Public title
The effect of acupressure in two points; Sanyingjiao (Sp6) and Taichong (Liv3) on improvement of women’s sexual function and quality of sexual life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with
Being in the permanent and monogamous marital relationship
Having at least level of reading and writing literacy
Exclusion criteria:
Having sexual dysfunction being in the treatment process
Addiction to narcotic drugs and alcohol
Her husband has sexual dysfunction
Positive history of unpleasant psychological experiences in the past six months
Being in the pregnancy, lactation, and menopause period
Having psychological and physical well-known chronic disease that affect sexual function
Using drugs that effect the sexual function
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization method will be randomized block design with block size of 4. The block randomization method is designed to randomize participants into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. in this clinical trial with control and treatment groups, a randomized block procedure would be as follows: (1) a block size of 4 will be chosen, (2) possible balanced combinations with 2 A (intervention) and 2 B (control) subjects will be calculated as 6 (BBAA, BABA, BAAB, ABBA, ABAB, AABB) and (3) blocks will be randomly chosen to determine the assignment of all participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences, school of Nursing and Midwifery & Rehabil
Street address
Faculty of Nursing and Midwifery, South Nosrat Ave., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.TUMS.FNM.REC.1398.079
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Quality of sexual life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention, immediately and 4 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
2
Description
Quality of sexual life
Timepoint
Before the intervention, immediately and 4 weeks after the intervention
Method of measurement
Sexual quality of life-female (SQOL-F) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be trained by the researcher during two educational sessions. In these sessions, the acupressure technique, its benefits, and the correct location of the Liv3 and Sp6 points will be introduced to samples. Then, the sample in the presence of the researcher apply these points to their body and apply acupressure. The intervention will take place for 8 weeks by individuals in the intervention group. Researcher will be remember and follow the applying of the intervention by the sample through calling.
Category
Other
2
Description
Control group: The control group will not receive intervention. However, according to ethical consideration, if each member of the control group tends to receive an intervention service, they will be given it by the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers affiliated Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Street address
Tehran, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6119 0000
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraian, the Vice Chancellor of Research at Tehran University of Medicine Sciences
Street address
Keshavarz Blv., Qods St.,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after unrecognizable process of participants.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Research results would be available for academic researchers
Under which criteria data/document could be used
Research results would be available for same researches
From where data/document is obtainable
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author