Protocol summary

Summary
The present study aimed to investigate the effect of behavioral-cognitive therapy to improve the sexual function, satisfaction and self-efficiency in first-pregnancy women that increases spouse satisfaction and make the family relations strong. The inclusion criteria involve: first pregnancy, age of 18-35, pregnancy age of 14-16 weeks. The exclusion criteria involve: abortion history, alcohol use, smoking, drugs effective on sexual tendency, having chronic diseases, having sexual disorder before pregnancy,having Pregnancy complications. This clinical trial included three separate questionnaires such as questionnaire of sexual function, satisfaction and self-efficiency. Those who received low score in all three questionnaires (n=32)were selected. Samples are randomly divided into two control and treatment groups. The treatment group received eight session of cognitive- behavior counseling and control group received routine pregnancy care. Then two weeks and 4 weeks after finishing interventions, post-test was performed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111230850N1
Registration date: 2017-01-24, 1395/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Mina Nezamnia
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 4421 7538
Email address
minanezamnia@gmail.com
Recruitment status
Recruitment complete
Funding source
University of Jundishapur of Ahvaz
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of cognitive-behavioral therapy on sexual function, sexual satisfaction and self- efficiency in Nulliparous pregnant women
Public title
The impact of cognitive-behavioral therapy on sexual function, sexual satisfaction and self- efficiency in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: have at least read and write, aged 18 to 35 years; first pregnancy; gestational age 14 to 16 weeks Exclusion criteria: having a history of miscarriage; pregnancy complications (placenta previa threatened abortion، gestational hypertension); sexual disorder before pregnancy; use alcohol and cigarettes; drugs that affect sexual desire (such as antihypertensive drugs of antidepressants); having chronic physical and mental illnesses
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Department of Research and Information Technology University of Medical Sciences, Ahvaz Jundishapour, Ground Floor, City University
City
Ahvaz
Postal code
15794-61357
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.AJUMS.REC.1395.484

Health conditions studied

1

Description of health condition studied
Disorder of sexual function
ICD-10 code
f52.9
ICD-10 code description
lack or disorder of sexual function

Primary outcomes

1

Description
Sexual self-efficacy index
Timepoint
Before the intervention, two weeks and four weeks after the intervention.
Method of measurement
Schwartz sexual self-efficacy questionnaire

2

Description
Female Sexual Function Index(FSFI)
Timepoint
Before the intervention, two weeks and four weeks after the intervention.
Method of measurement
Female Sexual Function Questionnaire

3

Description
Sexual Satisfaction Index(ISS)
Timepoint
Before the intervention, two weeks and four weeks after the intervention.
Method of measurement
Larson Sexual satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Consultations are done a week for 8 sessions of 45-minute sessions on an individual basis and Each session has a specific structure
Category
Behavior

2

Description
The control group only received prenatal care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
East's number one health center in Ahvaz
Full name of responsible person
Minanezamnia
Street address
Ayatollah Behbahani superhighway,7 tir park opposite
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr Behzad Makhmal zade
Street address
Ahvaz Jundishapur University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahvaz University of Medical Sciences
City
Ahvaz
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, Ahvaz JundiShapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina Nezamnia
Position
Student Master of consultation in Midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, College of Nursing and Midwifery
City
Ahvaz
Postal code
7661738117
Phone
+98 61 3336 7543
Fax
Email
Minanezamnia@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina Irvani
Position
Phd of reproductive health
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, College of Nursing and Midwifery
City
Ahvaz
Postal code
09861357- 15794
Phone
+98 61 3336 7543
Fax
Email
minairavani2004@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina Nezamnia
Position
Student Master of consultation in Midwifery
Other areas of specialty/work
Street address
Kuzestan-Ahvaz-Golestan Blvd
City
Bam
Postal code
7661738117
Phone
+98 936 308 7317
Fax
Email
minanezamnia@gmail.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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