1. Home
  2. Approved trials
  3. » فارسی

Efficacy of sexual counseling on sexual behaviors in women with endometriosis, candidates for laparoscopic surgery.

Protocol summary

Study aim
To determine the effect of sexual counseling on sexual behaviors in women with endometriosis candidate for laparoscopic surgery.
Design
The research is a single-blind randomized clinical trial with two groups: intervention and control. women with endometriosis will be randomly divided into two groups of 30 each using a table of random numbers.
Settings and conduct
The setting of the study is Hazrat-e Rasool Akram affiliated to Iran University of Medical Sciences. Study objectives will be explained to women with endometriosis who is the candidate for laparoscopic surgery and informed written consent will be taken. 60 women with endometriosis will be randomly divided into two groups (intervention and control) by using the computer-generated table of random numbers. Sexual behavior and quality of life questionnaires will be completed in both control and intervention groups, prior to any intervention. In the intervention group, sexual counseling based on the PLISSIT model will be conducting weekly for 3 weeks and, laparoscopic surgery would be performed 4 weeks after the last session. Sexual behavior and quality of life questionnaires in the 3rd and 6th months after laparoscopic surgery will be completed by the patients and the results will be compared.
Participants/Inclusion and exclusion criteria
Women with endometriosis referring to Hazrat-e Rasool Akram will be enrolled according to inclusion criteria.
Intervention groups
In the intervention group, sexual counseling will be done, prior to laparoscopic surgery. They will receive three counseling 45-minute sessions based on the PLISSIT model. Four weeks after counseling sessions women will undergo laparoscopic surgery.
Main outcome variables
Efficacy of sexual counseling on sexual behaviors in women with endometriosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038567N1
Registration date: 2018-08-04, 1397/05/13
Registration timing: prospective

Last update: 2018-08-04, 1397/05/13
Update count: 0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
shahla chaichian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
chaichian.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of sexual counseling on sexual behaviors in women with endometriosis, candidates for laparoscopic surgery.
Public title
Efficacy of sexual counseling on sexual behaviors in women with endometriosis, candidates for laparoscopic surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not pregnant Sexually active Heterosexual Sexual dysfunction or dyspareunia during last 6 months Diagnosis of endometriosis by clinical symptoms (dysmenorrhea, dyspareunia, dysuria, dyschezia, pelvic pain, infertility, hematuria, etc.) clinical examinations examination, and imaging methods(ultrasound, MRI,…), Pelvic pain associated with endometriosis Negative history of hormonal medications (contraceptive pill, gonadotropins, etc.) during the last 3 months. No gynecologic malignancy Negative history of underlying diseases such as cardiovascular, respiratory, renal, hematological, liver, rheumatologic and neurological diseases, psychological disorders in women and spouses Negative history of psychiatric drugs by couple Interested in collaborating in research
Exclusion criteria:
Failure to prove endometriosis by surgery The unwillingness of endometriosis women to participate in the study
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 women with endometriosis will be divided into two groups of 30 by a computer-generated table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
ِDouble-blinding ( consisting of outcome assessor and care provider(surgeon)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
IR.IUMS.REC 1396.32134

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.9:
ICD-10 code description
Endometriosis, Unspecified

Primary outcomes

1

Description
Sexual behaviors
Timepoint
Before intervention, 3 and 6 months after intervention
Method of measurement
Using sexual behavior questionnaires (Female Sexual Function Index, sexual distress, Sexual satisfaction scale for women, Multi- dimensional sexual self-concept).

Secondary outcomes

1

Description
Quality Life
Timepoint
Before and 6 months after intervention.
Method of measurement
The endometriosis health profile questionnaire-30

Intervention groups

1

Description
Intervention group: Intervention group will receive three 45-minute PLISSIT based (the first three stages) individual sexual counseling sessions weekly. Stage1: Permission Stage 2: Limited information Stage3: Specific suggestions. After 4 weeks Laparoscopic surgery will be performed.
Category
Behavior

2

Description
Control group: In the control group, women with endometriosis will only undergo laparoscopic surgery.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Shahla Chaichian
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
shahlachaichian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
Street address
Iran University of Medical Science, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shahlachaichian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shahla chaichian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
shahlachaichian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla chaichian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
shahlachaichian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla chaichian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
shahlachaichian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...