Protocol summary

Summary
The aim of this study is to assess the efficacy of performing educational package (training in the field of menopause, sexual function and dysfunction, stimulus control, sensate focus, real confrontation and conflict intervention) based on consultant midwife, on sexual function in postmenopausal women and sexual satisfaction of middle-aged couples. The study is a single blind controlled randomized clinical trial. The study population will consist of postmenopausal women aged 44-55 years and their wives who will attend primary health care centers in Mahmoud Abad, who has sexual dysfunction that identify through research tool. If they have tendency to participate in the study, with their wives will be randomly allocated in intervention group (n=50) and control group (n=50). Randomization is performed by Random sequence generator software. Participants with conditions of include criteria of the study and natural menopause will have the right to participate in the study. Sessions will be established to a single couple. The study questionnaire include of demographic information, FSFI, IIEF, GHQ, ISS, check table the positive and negative stimuli identification impact on sexual function. Validity and reliability of these tools were confirmed. At baseline, participant in both groups will complete questionnaires. A week later, the intervention group will be present in training sessions (four sixty-minute session once a week). Two weeks later, post-test and fallow-up of the two groups in terms of sexual function and satisfaction will be done two months later. The person assessing the outcome, about the group that belongs the participant in it, is blind. In the control group, during the study will not be any intervention, but to consider the ethical aspects, after doing research, training manual containing the contents of the meetings will be presented to them.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112631117N1
Registration date: 2016-12-16, 1395/09/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-16, 1395/09/26
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences, Sari, Iran
Expected recruitment start date
2016-11-07, 1395/08/17
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effectiveness of performing educational package based on consultant midwife on sexual function in postmenopausal women and sexual satisfaction of middle-aged couples
Public title
Investigate the effectiveness of performing educational package based on consultant midwife on sexual function in postmenopausal women and sexual satisfaction of middle-aged couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: A written consent to participate in the study; Their husbands alive and living with his wife; One year from the last menstrual period of the past; They have a natural menopause; Obtaining a score less than 26/5 of the scale of sexual function; Having basic literacy; Having age between 44 to 55 years; Having sexual dysfunction, at least in the last 4 weeks; Lack of drug addiction; No diagnosis of severe physical or mental disease in postmenopausal women, according to GHQ questionnaire. Exclusion criteria: The receipt of any psychological or additional treatment such as hormone therapy for menopause before or during the study; Chronic diseases such as advanced physical and mental diabetes, multiple sclerosis, heart disease and psychosis; The occurrence of any event or crisis in their life such special events as the death of relatives, incurable disease in family members in the last month; receive any formal education about sex before or during the study; The absence of the wife of training sessions and Consultancy; Diagnosis of impotence in the IIEF questionnaire wife.
Age
From 44 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ethics committee of Mazandaran University of Medical sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem square, Moalem street
City
Sari
Postal code
4816715793
Approval date
2016-11-06, 1395/08/16
Ethics committee reference number
IR.MAZUMS.REC.95.2574

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure

Primary outcomes

1

Description
Sexual function in postmenopausal women
Timepoint
A week before, two weeks after the last sessions, two months after the last sessions
Method of measurement
Female Sexual Function Questionnaire Rosen

Secondary outcomes

1

Description
Sexual satisfaction of middle-aged couples.
Timepoint
A week before, two weeks after the last sessions, two months after the last sessions
Method of measurement
International sexual satisfaction questionnaire Larson

Intervention groups

1

Description
Control group: This group during the study will not be any intervention, but to consider the ethical aspects, after doing research, training manual containing the contents of the meetings will be presented to them.
Category
Behavior

2

Description
Intervention group: Sessions will be established to a single couple. Educational – consultative sessions will be established four sixty-minute sessions once a week. The contents of the meeting include, training in the field of menopause, sexual function and dysfunction, stimulus control, sensate focus, real confrontation and conflict intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Healthcare Center, Mahmoud Abad, Iran
Full name of responsible person
Dr. Soghra Khani
Street address
Sexual and reproductive health research center, Nasibeh nursing and Midwifery faculty, Vesal street, Amir Mazandarani Boulvard.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square, Moalem Street.
City
sari
Grant name
Grant code / Reference number
IR.Mazums.rec.95.2574
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. Khani Soghra
Position
PHD/ Assistant Professor
Other areas of specialty/work
Street address
ُSexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir khanisog343@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. Khani Soghra
Position
PHD/ Assistant Professor
Other areas of specialty/work
Street address
ُSexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir khanisog343@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. Khani Soghra
Position
PHD/ Assistant professor
Other areas of specialty/work
Street address
ُSexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir khanisog343@gmail.com
Web page address
www.mazums.ac.ir

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
Loading...