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The effect of counseling based on EX-PLISSIT model on sexual function after hysterectomy

Protocol summary

Summary
This study is a Randomized controlled trial. Convenience Sampling will be done by reviewing medical records of patient in the hospital of Sari city. Based on the address and telephone recorded in the patient's files, women undergoing hysterectomy who are up to 50 years old and meet Inclusion criteria will be identified and contacted. In present meeting after gaining verbal consent, the research project will be explained, lake of anxiety and depression and existence of sexual dysfunction using DASS-21 and FSFI will be assessed, and written informed consent will be obtained. Eighty four participants will be assigned to intervention (n = 42) and control (n = 42) groups by blocked randomization. Basic tools including socio-demographic checklist, Enrich marital satisfaction questionnaire, Sexual Quality Of Life Questionnaire (SQOL-F), and Female Sexual Function Inventory (FSFI) for all participants will be completed. Sampling will be continued until to reach total sample size of the study. In the intervention group counseling based on EX-PLISSIT model will be held, at least in two one-hour counseling sessions once weekly. The number of sessions will be based on participants’ needs; and at least will be two sessions. The first three levels of model (Permission, Limited Information, and Specific Suggestions) will be done; and if there are professional problems (level 4 or Intensive Therapy), the patient will be referred to specialized centers. No intervention will be done in the control group. Eight weeks after the last session, participants in both groups will complete sexual performance, marital satisfaction and sexual quality of life using the relevant questionnaires, again. If the participants wish, counseling sessions will be held in the control group after reviewing the results at the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061428352N3
Registration date: 2017-02-15, 1395/11/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on EX-PLISSIT model on sexual function after hysterectomy
Public title
The effect of counseling based on EX-PLISSIT model on sexual function after hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; Having a husband and lack of separation from husband; Having a maximum of 50 years; Having junior school education and more (able to complete the questionnaire); Passing at least 3 months from the hysterectomy of person; Lack of any severe psychological stress such as an accident or loss of members of first grade during the last three months; Lack of physical and mental diseases known to affect sexual activity, Such as depression, anxiety, and stress (in order of score less than 10, 8 and 15 on scales of DASS-21 questionnaire), Cut of limb or quadriplegia, phobias, vaginismus, which need treatment); Lack of using drugs and medications that affect on sexual function (anti HTN drugs, thiazide diuretics, antidepressants, antihistamines, barbiturates, narcotics, diazepins, amphetamines, drugs and alcohol); Lack of underlying medical conditions (Heart, digestive, respiratory, epilepsy, hypertension), according to owns report; Sexual dysfunction (scores 28 and less in FSFI scale); Lake of surgery exept hysterectomy during the past 6 months in woman and her spouse; Lake of hysterectomy because of cancer; Lack of emotional problems with husband; Absence of sexual problems or debilitating diseases of husband. Exclusion criteria; Lake of Participation in counseling sessions for any reason; Not being sexually active during follow-up period; existance of Specialized sexual problems inpatient.
Age
To 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Zanjan University of Medical Sciences
Street address
North Side Azadi Boulevard
City
Zanjan
Postal code
45156-13191
Approval date
2016-11-01, 1395/08/11
Ethics committee reference number
ZUMS.REC.1395.176

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
sexual function
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
FSFI questionnaires

Secondary outcomes

1

Description
The quality of sexual life
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
SQOL-F Questionnaire

2

Description
sexual satisfaction
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Enrich Marital Satisfaction Questionnaire

Intervention groups

1

Description
In the intervention group,42 people, consisting of, advice is done according to EX PLISSIT model during at least two one-hour meetings on a weekly basis. intervention is done until The third step of this model,that is, ss,and in case of existence speacialized problem, the level 4 (Intensive Therapy) patients will be referred to specialized centers.The number of sessions will be based on participants’ needs, at least two sessions.
Category
Behavior

2

Description
Control group of 42 people and will be performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Maryeh Mahmoodi Dangesaraki
Street address
Imam Khomeini Hospital,Amirmazndrani Street,Sari,Mazandarn
City
Sari

2

Recruitment center
Name of recruitment center
Hekmat Hospital
Full name of responsible person
Maryeh Mahmoodi Dangesaraki
Street address
Hekmat Hospital,Taleghani Boulevard,Sari,Mazandarn
City
Sari

3

Recruitment center
Name of recruitment center
Nime Shaban Hospital
Full name of responsible person
Maryeh Mahmoodi Dangesaraki
Street address
Nime Shaban Hospital,Pasdaran Boulevard,Sari,Mazandarn
City
Sari

4

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Maryeh Mahmoodi Dangesaraki
Street address
Shafa Hospital,Vali'e Asr Boulevard,Sari,Mazandarn
City
Sari

5

Recruitment center
Name of recruitment center
Amir Mazandarani Hospital
Full name of responsible person
Maryeh Mahmoodi Dangesaraki
Street address
Amir Mazandarani Hospital,Amirmazandrani Street,Sar,Mazandarn
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chancellor for Research and Technology of Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
North Side Azadi Boulevard, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research and Technology of Zanjan University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Chancellor for Research and Technology of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moalem Square, Sari, Mazandaran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research and Technology of Mazandaran University of Medical Sciences
Proportion provided by this source
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
Zanjan University of Medical Sciences
Full name of responsible person
Maryeh Mahmoodi dangesaraki
Position
Msc student of midwifery counseliing
Other areas of specialty/work
Street address
Mahmoodi Apartment, Chamran1, Alley martyr Beheshti, moalem Street, Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3326 5513
Fax
Email
mariamahmoodi90@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery Zanjan, zanjan
City
Zanjan
Postal code
Phone
+98 24 3315 6344
Fax
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health/Supervisor
Other areas of specialty/work
Street address
School of Nursing and Midwifery Zanjan, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3315 6344
Fax
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir

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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