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Effectiveness of Sexual Counseling on Sexual Dysfunction of Women with Polycystic Ovarian Syndrome

Protocol summary

Summary
This study is a randomized controlled trials without blinding. The aim of the study the effectiveness of sexual counseling on sexual dysfunction of women with polycystic ovarian syndrome. Inclusion criteria include married, having sexual activity during past six months, the definitive of diagnosis of the polycystic ovarian syndrome by a gynecologist and records in document with is based on the criteria of the Rotterdam, having sexual function score that is less than 28 before intervention, etc. If one of the exclusion criteria has happen, such as, missing one of the session, the patient cannot continue the study. The method of sampling is available sampling and then eighty women that are sexual scores less than 28, randomly, will be in working and control group by Balanced Block Randomization method. Intervention for working group include four individual counselling sessions for 60 minutes’ consultation in accordance with PLISSIT model that will be carried out once a week. The first session is Permission, second session, Limited Information, third session, Specific Suggestion and the end session is Intensive Therapy. At the end of the intervention, training manual prepared and will be presented for control group. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512023034N16
Registration date: 2017-04-14, 1396/01/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Mansoureh Jamshidimanesh
Name of organization / entity
Iran University Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1811
Email address
delshad2@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy School of Nursing and Midwifery , Iran University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Sexual Counseling on Sexual Dysfunction of Women with Polycystic Ovarian Syndrome
Public title
Effectiveness of Counseling on Sexual Dysfunction of Women with Polycystic Ovarian Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Married; 18_45 years’ old; Iranian; Having at least degree of knowledge; Having sexual activity during past six months; The definitive diagnosis of the polycystic ovarian syndrome by a gynecologist and records in document which is based on the criteria of Rotterdam; Having sexual function score that is less than 28 before intervention; Lack of pregnancy and lactation and unwillingness to be pregnant during intervention; Lack of other acute physical and mental disease and endocrine disorder like thyroid disorders, diabetes based on the patient’s medical document; Lack of consumption alcohol and drugs by patients and her husband according to the patient’s reports; Lack of consumption drugs that are effective on sexual activity like ant depression, antihypertensive drugs...; Lack of consumption of any drugs or hormonal intervention during the last 60 days before intervention; Lack of history of women surgery such as genital surgery and breast surgery; Lack of sexual dysfunction by patient’s husband (according to patients reports); Lack of participation in training classes to counseling for sexual dysfunction; Lack of stressful events that are unrelated to pregnancy Exclusion criteria: Missing one of the session; Occurrences of stressful events that are unrelated to pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to the Milad Tower,Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
19964
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.IUMS.REC1395.9311373024

Health conditions studied

1

Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Satisfication
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

2

Description
Arousal
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

3

Description
Lubrication
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

4

Description
Orgasm
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

5

Description
Desire
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

6

Description
Sexual Dysfunction
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

7

Description
Pain
Timepoint
Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire
Method of measurement
Female Sexual Function Index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First, the Female sexual Function Index questionnaire (FSFI) will be completed by 80 patients with inclusion criteria in the presence of researcher, individually . Then randomely , patients will be divided into two groups, intervention and control groups in the same time .Intervention for working group include four individual counseling sessions for 60 minutes’ consultations in accordance with PLISSIT model that will be carried out once a week by researcher. The first meeting after introduction and description of the goal of study, the first step (Permission) runs. At this stage, the patient will be allowed to speak about her sexual problems. At this stage, counseling techniques such as listening skills and pay attention to non-verbal gestures will be used and understood false beliefs and knowledge of patients and by collecting history and completed Sexual Function Index questionnaire, their problems will be diagnosised. At second session (Limited Information) which consultant will talk about the anatomy and physiology of the reproductive system and sexual cycle. In addition, explain about the disease, its side effects and its effect on sexual function and for a better understanding, slides and images color will be used. Third session (Specific Suggestion) according to each patient by clients help, suggestions for remission of the disease will be done. For example,sensate focus technique,exersice, massage and etc, due to personal problem will be advised. Last session (Intensive Therapy) is the final step. Patients who pass previous three sessions of counseling are suspected to any mental disorder, a history of rape and etc., will be referred to health professionals. At the end of he each session, summery of that session, will be given to clients such as brochures and booklet. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed.
Category
Other

2

Description
At the end of intervention, training manual wich contains information about sexual responsive cycle, physiology and anatomy of the genital tract, polycystic ovarian syndrome and its side effects, etc, prepared and will be presented for the control group. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar General Hospital
Full name of responsible person
Fahimeh Golbabaei, Master of Midwifery Student
Street address
Firoozgar General Hospital, Beh Afarin St. , Karimkhan St. , Valiasr Sq. , Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr Rafiei Frough, Dr Mousavi Alijavad
Street address
Iran University of Medical Sciences, Next to the Milad Tower, Shahid Hemmat Highway , 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, School of Nursing and Midwifery, 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
School Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fahimeh Golbabaei
Position
Master of Midwifery Student
Other areas of specialty/work
Street address
Iran University of Medical Sciences, School of Nursing and Midwifery, Rashidyasemi St. , Valiasr St. , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
farnaz2006_1000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr Mansoureh Jamshidimanesh
Position
Phd of Reproductive Health
Other areas of specialty/work
Street address
Iran University of Medical Sciences, School of Nursing and Midwifery, Rashidyasemi St. , Valiasr St. , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
Jamshidimanesh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery , Iran University of Medical Sciences
Full name of responsible person
Fahimeh Golbabaei
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
Iran University of Medical Sciences, School of Nursing and Midwifery, Rashidyasemi St. , Valiasr St. , Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
farnaz2006_1000@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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