Protocol summary

Summary
This study aimed at determining the effect of an educational program based on PRECEDE model to improve sexual function in women with hysterectomy. In this randomized clinical trial, 48 married women who had been had hysterectomy at least two months before the study, were selected through convenience sampling and randomly divided into two equal groups as intervention and control. Inclusion criteria were: voluntary participation in the study; signing written consent; at least 2 months after total abdominal hysterectomy; being married and monogamous; no known physical or mental illness;r long-term use of any drug; and not away from husband. Exclusion criteria were: immigration; oophorectomy; hormone therapy; hysterectomy due to malignancy. Before intervention needs assessment were done using a researcher-made questionnaire( in according to the constructs of the PRECEDE model including predisposing, reinforcing and enabling factors , and the Rosen Female Sexual Function Index was used to measure the sexual function. Educational intervention was conducted based on a needs assessment in according to the constructs of the PRECEDE model in 5 sessions. Then both questionnaires were completed again four weeks after intervention and predisposing, reinforcing and enabling factors and sexual function of the before and after interventions were compared.

General information

Acronym
Predisposing, Reinforcing and Enabling Constructs in Educational Diagnosis and Evaluation
IRCT registration information
IRCT registration number: IRCT2014122220401N1
Registration date: 2015-01-06, 1393/10/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Nazafarin Hosseini
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseini.nazafarin@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the behavioral intervention based on PRECEDE model on the sexual function in women after hysterectomy in Yasuj public hospitals, 1392
Public title
The effect of the behavioral intervention on the sexual function in women after hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: voluntary participation in the study; signing written consent; at least 2 months after total abdominal hysterectomy; being married and monogamous; no known physical or mental illness; long-term use of any drug; and not away from husband due to Various reasons Exclusion criteria: immigration; oophorectomy; hormone therapy; hysterectomy due to malignancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Yasuj University of Medical Sciences
Street address
Yasuj, near Imam Sajad Hospital, Yasuj University of Medical Sciences, third floor,School of Nursing and Midwifery
City
Yasuj
Postal code
94799-75919
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
92.12.25.9

Health conditions studied

1

Description of health condition studied
sexual function in women with hystrectomy
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified

Primary outcomes

1

Description
sexual function in women after hysterectomy
Timepoint
before intevvention and 1 month after intervention
Method of measurement
Rosen Female Sexual Function Index

Secondary outcomes

1

Description
need assessment( determining predisposing factors, enabling factors, reinforcement factors of sexual functiona
Timepoint
before intervention, 1 month after intervention
Method of measurement
researcher made need assessment questionnair in according to structures of PRECED model

Intervention groups

1

Description
intervention group: provided educational program by a researcher in 5 sessions of 45-60 minutes once a week through speech, questions and answers, slideshow and practical training of skills based on a needs assessment and with an emphasis on predisposing, enabling and reinforcing constructs of the PRECEDE model
Category
Behavior

2

Description
The control intervention: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sasjad Hospital
Full name of responsible person
Dr Parvin Ghaffari
Street address
Yasuj- shahid Jalil street- Imam Sajad Hospital- second floor- Gynecology ward
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Sciences, Deputy of research and technology
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Yasuj- Shahid Motahary Boulevard- Central house of Yasuj University of Medical Sciences, deputy of Research and Technology Vice chancellor
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj University of Medical Sciences, Deputy of research and technology
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
Yasuj university of medical sciences
Full name of responsible person
Akram Amini
Position
Msc student nursing education
Other areas of specialty/work
Street address
Yasuj- Shahid Jalil street- Yasuj university of medical sciences- second floor- school of nursing and midwifery
City
Yasuj
Postal code
Phone
+98 74 3323 5144
Fax
Email
arezo.amini21@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj Univercity of Medical Sciences
Full name of responsible person
Dr Nazafarin Hosseini
Position
PhD in Nursing
Other areas of specialty/work
Street address
Yasuj- Shahid Jalil Street- Yasuj Univercity of Medical Sciences, second floor- school of nursing and midwifery
City
Yasuj
Postal code
94799-75919
Phone
+98 74 3323 5144
Fax
+98 74 3323 4115
Email
hosseini.nazafarin@yums.ac.irhosseinichenar@yahoo.com
Web page address

Person responsible for updating data

Contact

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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