Comparision the Effectiveness of Counseling based on two models of PLISSIT and BETTER on Sexual function and Sexual self-disclosure of women after childbirth
Comparision of the effectiveness of sexual couseling based on PLISSIT and BETTER models on sexual function and sexual self-disclosure of women after childbirth
Design
A total of 80 women with score 28 or less than 28 in FSFI questionnaire between 4weeks to 6 months after chilldbirth randomly divided into two groups of PLISSIT and BETTER by table of random numbers.
Settings and conduct
A total of 80 women with history of sexual problem between 4weeks to 6 months after chilldbirth, will be randomized into one of the groups. subjects were allocated to each group ofPLISSIT and BETTER randomly by Table of random numbers. First group will receive PLISSIT model and BETTER model will be implemented for the second group. Both groups will participate in two sessions. All enrolled subjects will be assessed for demographic characteristics, sexual function, sexual self-disclosure, stress, depression and anxiety.Not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Giving a written consent; Having literacy; Being iranian and living in Mashhad; Having a single child in recent pregnancy; Age 20-45 years; Married and having an intact marriage; Participate in study from 4weeks to 6 months after delivery; Having sex sfter delivery; Score 28 or less than in FSFI questionnaire; Do not have chronic medical history that affect on sexual function; Term pregnancy.Exclusion criteria: Alcohol and other form of drug abuse; Severe mental disorder; Participate in sexual educational sessions outside the study enviroment; Taking medications that affect sexual function in woman or her husband; Prostatic and sexual dysfunction in husband; Postpartum complications inrecent delivery; History of surgical procedures or pelvic radiotherapy.
Intervention groups
PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy):The subjects in this group will receive five 60-90 minute therapy sessions.St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist.BETTER treatment model:The subjects in this group will receive five 60-90 minute therapy sessions.BETTER model include 6 steps.St1: Bring up;the counselor simply speaks to the client about sexual issues and tells them that he can talk quite comfortable. In fact, this step is to give the client a chance to talk about sexual issues and identify her attitudes. St2: Explain; The consultant explains the importance and impact of sexual issues on quality of life, and also tells the reader that it is completely free to talk about this. It helps to normalize sexual discourse and reduce feelings of shame.St3: TELL; The consultant assures the client that she will provide all his information to solve her problem. St4:Time; The counseling time is determined on the basis of the patient's preference. St5: Educate; The counselor will educate the patient about the complications of childbirth, the effects of childbirth on sexual matters.St6: Record; Interventions and therapeutic outcomes are recorded.At the end one month after the last sessions, the degree of sexual self-disclosure and sexual function score Sex is measured.
Main outcome variables
sexual function; sexual self-disclosure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170430033718N3
Registration date:2018-03-07, 1396/12/16
Registration timing:registered_while_recruiting
Last update:2018-03-07, 1396/12/16
Update count:0
Registration date
2018-03-07, 1396/12/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 795 8503
Email address
karimifr941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the Effectiveness of Counseling based on two models of PLISSIT and BETTER on Sexual function and Sexual self-disclosure of women after childbirth
Public title
Comparison the Effectiveness of counseling based on PLISSIT and BETTER models on sexual function and sexual self-disclosure of women after childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Giving a written consent
Having literacy
Being iranian and living in Mashhad
Having a single child in recent pregnancy
Age 20 t0 45 years
Married and having an intact marriage
Participate in study from 4 week to 6 months after delivery
Having sex after delivery
Score 28 or less than 28 in FSFI questionnaire
Do not have chronic medical history that affect on sexual function
Term pregnancy
Exclusion criteria:
Alcohol and other form of drug abuse
Severe mental disorder
Participate in sexual educational sessions outside the study enviroment
Taking medications that affect sexual function in woman or her husband
Prostatic and sexual dysfunction in husband
postpartum complications in recent delivery
History of surgical procedures or pelvic radiotherapy
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The initial selection of samples was a multistage cluster. From the five health centers of Mashhad, two comprehensive health services were selected randomly (centers number 1 and 3). Then, among the centers of health center number one, two centers (one in city and the other is the margin) through the lottery. For the health center number three, we also work the same way. Of the 4 centers selected (2 centers are in the margin area and 2 centers in the non-marginal area of Mashhad) we select one health center by lottery, which collects 4 base stations. Of all 4 centers and 4 bases, 10 eligible samples are selected as unpredictable. In order to prevent the exchange of information, Participants in centers and sub-bases receive counseling in two different ways.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
subjects were allocated to each group of intervention and control randomly by Table of random numbers. First group will receive PLISSIT model and BETTER model will be implemented for the second group. Both groups will participate in two sessions. All enrolled subjects will be assessed for demographic characteristics, sexual function, sexual self-disclosure, stress, depression and anxiety.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.MUMS.REC.1396.160
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
F52.9
ICD-10 code description
Primary outcomes
1
Description
Sexual Function
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
female sexual function index
2
Description
Sexual self-disclosure
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Hurlbert Sexual Self-disclosure questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress.PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy):The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the two therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge. One month after the last session, sexual self-disclosure and sexual function are re-measured.
Category
Other
2
Description
Intervention group2: Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress. BETTER model(Bring up,Explain,Tell,Time,Educate,Record). The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the BETTER treatment model including six therapeutic stages. St1: Bring up; In the first step, the counselor simply speaks to the client about sexual issues and tells them that he can talk quite comfortable. In fact, this step is to give the client a chance to talk about sexual issues and identify her attitudes. St2: Explain; The consultant explains the importance and impact of sexual issues on quality of life, and also tells the reader that it is completely free to talk about this. It helps to normalize sexual discourse and reduce feelings of shame.St3: TELL; The consultant assures the client that she will provide all his information to solve her problem. St4:Time; The counseling time is determined on the basis of the patient's preference. Since rebuilding sex is a continuous process, the counselor should be available to address the concerns and respond to the patient's questions. St5: Educate; The counselor will educate the patient about the complications of childbirth, the effects of childbirth and lactation on sexual matters, so that her concerns go away. The counselor must be familiar with the client's knowledge of how to deal with sexual problems in order to correct misconceptions about proximity to delivery. St6: Record; Assessments, interventions and therapeutic outcomes are recorded. In order to prevent samples from falling and respond to their health problems, the researcher will frequently contact with the individuals during the visits. At the end one month after the last session, the degree of sexual self-confidence and performance score Sex is measured again.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamt comprehensive Health Services Center
Full name of responsible person
Dr Motahari
Street address
28 Emamt, Emamat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3667 8431
Email
karimifr941@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ahmadi comprehensive Health Services Center
Full name of responsible person
Effat Ghabel
Street address
Ghareni Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3726 8710
Email
karimifr941@mums.ac.ir
3
Recruitment center
Name of recruitment center
Valiasr comprehensive Health Services Center
Full name of responsible person
Maryam Rezaii
Street address
No. 379, 28 Tabarsi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3211 3324
Email
karimifr941@mums.ac.ir
4
Recruitment center
Name of recruitment center
Emam Hadi comprehensive Health Services Center
Full name of responsible person
Dr Mohammadzade
Street address
No. 7 Emam Hadi, Emam Hadi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3667 8431
Email
karimifr941@mums.ac.ir
5
Recruitment center
Name of recruitment center
Banafshe health center
Full name of responsible person
Dr Alizadeh
Street address
No. 10, Fakhr Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3767 3922
Email
karimifr941@mums.ac.ir
6
Recruitment center
Name of recruitment center
Sina health center
Full name of responsible person
Dr Mohammadzade
Street address
No. 40, Toos Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3667 8430
Email
karimifr941@mums.ac.ir
7
Recruitment center
Name of recruitment center
Bahman health center
Full name of responsible person
Dr Motahari
Street address
NO. 25, Emamat Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3606 2001
Email
karimifr941@mums.ac.ir
8
Recruitment center
Name of recruitment center
Sanaii health center
Full name of responsible person
Dr Ahangari
Street address
No. 49, Motahari Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 51 3729 0071
Email
karimifr941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Robabe Latifnezhad
Street address
Daneshgah street, Ghoreshi building, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
951-91735
Phone
+98 51 3852 8512
Email
latifnezhadR@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh karimi
Position
Midwifery Master, Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing and Midwifery Faculty, Doktora Crossroads, Avicenna Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3605 0971
Fax
Email
Karimifr941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rahele Babazadeh
Position
PHD, Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing and Midwifery Faculty, Doktora Crossroads, Avicenna Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3605 0971
Fax
Email
BabazadehR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh karimi
Position
Midwifery Master, Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing and Midwifery Faculty, Doktora Crossroads, Avicenna Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3605 0971
Fax
Email
Karimifr941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available