Protocol summary

Summary
The present research is a Trial educational study which was carried out in the Arak city in the winter of 2014 in order to investigate the effects of cognitive – behavioral trainings on pregnant women's, sexual Function and Attitudes dysfunction sexual. The study population consisted of all pregnant women who were under the control of health clinics of Arak city. The admission criterion for the study was the lack of a ban on sexual intercourse due to medical reasons, lack a history of untreated sexual problems, lack of using medications which might affect sexual response, having at least the intermediate education, the age range of 18-35 years old, pregnancy ranking of 1-2, gestational age of less than 33 weeks and if any of the pregnant women who for whatever reason were in trouble during pregnancy and were not willing to continue training sessions were excluded from the study. The five health clinics were randomly selected out of health clinics covered by the Arak city as a single- stage cluster form. out of every health clinic, 20 pregnant women (a total of 100 pregnant women) who have Inclusion criteria were given a researcher- made attitude questionnaire and Sexual Function. The researcher, in individual interviews with pregnant women, was received a written consciously testimonial from people willing to participate and were qualified to enter the study. After giving an explanation on how to complete the questionnaire, out of the total women, only 22 participants who obtained lowest score in the questionnaires were selected. The questionnaires were then placed in a sealed box. The first person was categorized in the intervention group through lottery and then people were placed in two groups alternately. Some meetings were prepared for each person in intervention group. Cognitive-behavioral therapy sessions were held weekly at eight 90 minutes sessions. The treatment was performed using techniques such as speech, question & answer, looking photos, videos, PowerPoint and giving pamphlet. One another group of 11 people were enrolled in the control group, so that no additional training was carried out on what receive routinely and during pregnancy cares by health care workers. after the end of sessions, attitudes and sexual function post test questionnaire was completed by the intervention and control groups and the obtained results were characterized and compared. Then, considering the significance of the research done, three months later the attitude questionnaire was completed again by pregnant women of control the intervention groups for follow-up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070423057N1
Registration date: 2015-09-09, 1394/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Maryam Kheyri
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 633124541
Email address
m.kheiry@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Arak research university of medical sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of cognitive- behavioral trainings on sexual dysfunctional attitudes and sexual function in pregnant women
Public title
The impact of cognitive- behavioral trainings on sexual dysfunctional attitudes and sexual function in pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
The admission criterion: For the study was the lack of a ban on sexual intercourse due to medical reasons؛ lack a history of untreated sexual problems؛ non-addiction؛ lack of using medications which might affect sexual response؛ lack of known physical or mental and medical diseases based on report declared by individual himself؛ no adverse event during the 3 months prior to the study؛ living with a permanent partner؛ having at least the intermediate education؛ the age range of 18-35 years old؛ pregnancy ranking of 1-2 ؛ gestational age of less than 33 weeks. The Exclusion criteria: If any of the pregnant women who for whatever reason were in trouble during pregnancy and were not willing to continue training sessions were excluded from the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
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
Ethics committee of the university of medical sciences
Street address
Department of education and research، the university of medical sciences site، Basij square، Arak
City
Arak
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
93-174-14

Health conditions studied

1

Description of health condition studied
Attitudes sexual dysfunction and sexual function
ICD-10 code
Z70
ICD-10 code description
Counselling related to sexual attitude, behaviour and orientation

Primary outcomes

1

Description
Sexually dysfunctional attitudes
Timepoint
Before training, after training, follow-up three months later
Method of measurement
Attitudes questionnaire researcher

Secondary outcomes

1

Description
Sexual function
Timepoint
Before training, after training, respectively, followed three months later
Method of measurement
Female sexual function index questionnaire(FSFI)

Intervention groups

1

Description
For the cases, face to face meetings prepared by the researcher were presented in a separate room. this Clinic Aristotle taught using lectures, answer questions, view photos, videos, PowerPoint and the pamphlets and booklets were performed. Training sessions of cognitive - behavioral weekly meetings and 8 meeting lasted 90 minutes, was the content of training sessions in order Sessions First session: Referrals The second session: Of the damage to the baby's sex during pregnancy? Third session: Whether sex during pregnancy is causing damage to your mother? Fourth session: Whether sex during pregnancy is a sin? Fifth Session: Is sex during pregnancy increases the mental health of the pregnant women? Sixth session: Is sex during pregnancy is enjoyable for me? Seventh session: Whether sex during pregnancy is the problem? Eighth session: To evaluate the progress of pregnant women and reassess their attitude
Category
Behavior

2

Description
the control group received no additional training on what to routine prenatal care from health workers not received
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Aristotle's health clinic
Full name of responsible person
Maryam Kheyri
Street address
The town of Ali Ibn Abi Talib، Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak university of medical sciences
Full name of responsible person
D.r Ali Ghazavi
Street address
Post box 1884 , Department of education and research, university of medical sciences, the Basij, Arak
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
Maryam Kheyri
Position
Master
Other areas of specialty/work
Street address
Third floor, building Cactus, Delgosha streets, Khoram, Arak
City
Arak
Postal code
Phone
+98 86 3312 4541
Fax
Email
maryam.kheyri@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
Maryam Kheyri
Position
Master
Other areas of specialty/work
Street address
Third floor, building Cactus, Delgosha streets, Khoram, Arak
City
Arak
Postal code
Phone
+98 86 3312 4541
Fax
Email
maryam.kheyri@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
Maryam Kheyri
Position
Master
Other areas of specialty/work
Street address
Third floor, building Cactus, Delgosha streets, Khoram, Arak
City
Arak
Postal code
Phone
+98 86 3312 4541
Fax
Email
maryam.kheyri@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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