Protocol summary

Summary
This study aims to investigate the effectiveness of cognitive behavioral group therapy focusing on sexual self assertiveness in female orgasm. The design of the study is pre-test post-test quasi-experimental design. The study population is women who refer to the health care in selected centers in Tehran, Iran. Inclusion criteria: passing at least one year of marriage; not being on the verge of divorce; not trying to conceive until the next year; lack of menopause; lack of breastfeeding; non- chronic physical illness; non- use of certain medications that may affect sexual activity; having sex in the last four weeks; non-psychotic illnesses and axis 1 disorders (including depression and anxiety); non-addictive husband; not far from husband or polygamy; having a bachelors degree for women. Exclusion criteria: desire to stop working; pregnancy during the study; handling location. The data are gathered via a standard questionnaire whose validity and reliability are assured in advance. Sample size is equal to 22 women to intervention group (n=11) and control group (n=11) randomly. The cognitive behavioral intervention for intervention group consisted of 8 sessions cognitive behavioral group therapy focusing on sexual self assertiveness for two month and the control group did not receive any intervention. The primary outcome: increase orgasm. The secondary outcome: increase desire, psychological excitement, and sexual self assertiveness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120920256N1
Registration date: 2015-04-23, 1394/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-23, 1394/02/03
Registrant information
Name
Mina Chizari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 9151
Email address
m.chizari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of cognitive behavioral group therapy focusing on sexuall self assertiveness in female orgasm
Public title
Effectiveness of cognitive behavioral group therapy focusing on sexuall self assertiveness in female orgasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: passing at least one year of marriage; not being on the verge of divorce; not trying to conceive until the next year; lack of menopause; lack of breastfeeding; non- chronic physical illness; non- use of certain medications that may affect sexual activity; having sex in the last four weeks; non-psychotic illnesses and axis 1 disorders (including depression and anxiety); non-addictive husband; not far from husband or polygamy; having a bachelors degree for women. Exclusion criteria: desire to stop working; pregnancy during the study; handling location.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Vice chancellor for research, Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat, Arak
City
Arak
Postal code
3818146851
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
93-175-1

Health conditions studied

1

Description of health condition studied
Anorgasmia
ICD-10 code
F52.3
ICD-10 code description
Orgasmic dysfunction

Primary outcomes

1

Description
Orgasm
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index

Secondary outcomes

1

Description
Sexual self assertiveness
Timepoint
Before and after intervention
Method of measurement
Hurlbert Index of Sexual Desire

2

Description
Sexual desire
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index

3

Description
Psychological excitement
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index

Intervention groups

1

Description
Intervention group: 8 sessions cognitive behavioral group therapy focusing on sexual self assertiveness for ninety minutes in each sessions.
Category
Behavior

2

Description
Control group: control group did not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar abad center
Full name of responsible person
Dr. Tagbakhsh
Street address
Mahboob Mojaz st., Navab st., Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Farmanfarmaeeyan Center
Full name of responsible person
Dr. Bazargan
Street address
Roshdiyeh crossway. Azarbayjan st., Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
Shahid Ayat Center
Full name of responsible person
Dr. Shayegh
Street address
Behind Ghalemorghi Military complex, Front of Shariati Park
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafie
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mina Chizari
Position
MSc student of counselling in midwifery
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat, Faculty of nursing and midwifery
City
Arak
Postal code
3818146851
Phone
+98 86 3417 3645
Fax
Email
m.chizari@arakmu.ac.ir؛ mina_ch2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nafise Seyyed Zadeh
Position
MSc of midwifery
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat,Faculty of nursing and midwhfery
City
Arak
Postal code
3818146851
Phone
+98 86 3417 3645
Fax
Email
n_seyyedzadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mina Chizari
Position
MSc student of counselling in midwifery
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat
City
Arak
Postal code
3818146851
Phone
+98 86 3417 3645
Fax
Email
m.chizari@arakmu.ac.ir؛ mina_ch2000@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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