Objectives: evaluation of effectiveness of eye movement desensitization and reprocessing (EMDR) on sexual function,anxiety and quality of life of patients with vaginismus.
Design: 20 women with vaginismus will evaluat by non-probability sampling methods in a 6-month period of time.
Setting and conduct: after a short interview with the patients, demographic data will guttered. Then the female sexual function index (FSFI), Zung Anxiety Scale, quality of life (QOL) and Larson sexual questionnaires will complete .The patients will enter into the EMDR protocol. After EMDR sessions and also two months after the end of intervention, the questionnaires will complete again.
Inclusion criteria : diagnosis of vaginismus; age between 15 to 49 years; married; at least 9 grade of school education.
Exclusion criteria:physical causes of vaginismus; acute or chronic physical illness and other major psychiatric disorders; other therapies (pharmacological or behavioral therapy).
Intervention: Eye Movement Desensitization and Reprocessing (EMDR) protocol.
main outcome measures (variables): female sexual function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020126319N1
Registration date:2016-03-19, 1394/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-19, 1394/12/29
Registrant information
Name
Fatemeh Jebelli
Name of organization / entity
Isfahan University of Medical Sscience
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 3801
Email address
maroufi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of eye movement desensitization and reprocessing (EMDR) on sexual function of patients with vaginismus
Public title
Eye movement desensitization and reprocessing(EMDR) for vaginismus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : diagnosis of vaginismus; age between 15 to 49 years; married; at least 9 grade of school education.
Exclusion criteria:physical causes of vaginismus; acute or chronic physical illness and other major psychiatric disorders; other therapies (pharmacological or behavioral therapy).
Age
From 14 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jerib St, Isfahan
City
Isfahan
Postal code
Approval date
2014-12-10, 1393/09/19
Ethics committee reference number
393901
Health conditions studied
1
Description of health condition studied
Nonorganic vaginismus
ICD-10 code
F52.5
ICD-10 code description
Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful.
Primary outcomes
1
Description
sexual function
Timepoint
pre intervention, post intervention and three month later
Method of measurement
Female Sexual Function Index Questionnaire (FSFI); Larson sexual Questionnaire
2
Description
anxiety
Timepoint
pre intervention.post intervention and three month later
Method of measurement
Zung Anxiety Scale Questionnaire (SAS) and Larson sexual Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
befor intervention, after intervention and three month later
Method of measurement
Quality of Life Questionnaire (QOL)
Intervention groups
1
Description
The patients will enter into the EMDR protocol (eye movement desensitization and reprocessing). It contains of 8 phases each of them are done in one session.10 sessions of EMDR were considered for each patient
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychosomatic Research Center
Full name of responsible person
Fatemeh Jebelli
Street address
Shariaty St, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
DR Mansoor Siavash
Street address
Hezar Jerib St, Isfahan
City
Isfahan
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 Isfahan 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
Medicine School, Isfahan University of Medical Science
Full name of responsible person
Fatemeh Jebelli
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan
City
Isfahsn
Postal code
Phone
+98 31 3792 8134
Fax
Email
vcr-office@med.mui.ac.ir; fatemeh8188@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicine School, Isfahan University of Medical Science
Full name of responsible person
Fatemeh Jebelli
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Heza rJerib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 8134
Fax
Email
fatemeh8188@gmail.com; vcr-office@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medicine School, Isfahan University of Medical Science
Full name of responsible person
Fatemeh Jebelli
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 8134
Fax
Email
fatemeh8188@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)