Design: The study was a randomized clinical trial with two groups of experimental and control. It was conducted without blind.
Implementation: Pregnant women and their spouses, who were served by Daneshamooz and Kargaran health centers, will be investigated. Convenience sampling will be used based on the day of visit to health centers randomly. Then subjects will be divided into control and intervention groups after giving informed written consent and satisfying inclusion criteria.
Inclusion criteria
Pregnant woman: Being 18 to 35 years old; Be a planned pregnancy.
Inclusion criteria
husband: Be a planned pregnancy for her spouse; Does not have medical history; Has’nt sexual dissatisfaction during her pregnancy.
Exclusion criteria at the beginning of the study
Pregnant woman: Current Pregnancy is after infertility treatment; Tobacco smoking, drug user, alcohol consumption or psychoactive drug.
Exclusion criteria during the study
Pregnant woman: Lack of tendency of pregnant woman to continue her cooperation; Incomplete questionnaires.
Exclusion criteria at the beginning of the study
Husband: Tobacco smoking, drug user, alcohol consumption or psychoactive drug; Mental problem history.
Exclusion criteria during the study
Husband: Lack of tendency to continue his cooperation; Incomplete questionnaires; Occur stressful event during the study.
Intervention: Quality of sexual life and sexual satisfaction questionnaire will be filled in by both groups. Routine care consultation will be provided for control group. In intervention group, two sessions (60 to 90 minutes) will be held by a midwife researcher based on PLISSIT model with one week gap. The time of each session depends on mother’s problem and educational booklet will be given to the spouses of intervention group. Quality of sexual life and sexual satisfaction will be evaluated two and four weeks after intervention in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021324469N3
Registration date:2017-03-08, 1395/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Maryam Alizadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3259 2688
Email address
alizadehm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of counseling pregnant women on the PLISSIT model on quality of sexual life and sexual satisfaction couples in pregnancy
Public title
Effectiveness of counseling pregnant women on quality of sexual life and sexual satisfaction couples in pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
Pregnant woman:
giving a written consent; having literacy; Being Iranian and living in Mashhad; Being 18 to 35 years old; Be a planned pregnancy; Has an alive singleton pregnancy; Be the first, second, third or fourth pregnancy; Does not have medical history; Does not have obstetric complications during her pregnancy or high risk pregnancy; Has’nt sexual dissatisfaction during her pregnancy.
Inclusion criteria
husband
giving a written consent; having literacy; Being Iranian and living in Mashhad; Be a planned pregnancy for her spouse; Does not have medical history; Has’nt sexual dissatisfaction during her pregnancy.
Exclusion criteria at the beginning of the study
Pregnant woman:
Current Pregnancy is after infertility treatment; Tobacco smoking, drug user, alcohol consumption or psychoactive drug; Mental problem history; happening stressful events during the past 6 months; Has experienced abortion; Takes medicine affecting on mental health; Has sexually transmitted disease; Does have vaginal intercourse due to hit in pelvic area or penis deformity.
Exclusion criteria during the study
Pregnant woman:
Lack of tendency of pregnant woman to continue her cooperation; Incomplete questionnaires; Be admitted to the hospital due to problems related to pregnancy during the study; Occur stressful event during the study; Be inaccessible in the second and the fourth week after consultation; Questionnaire is not filled in by the spouse of the pregnant woman.
Exclusion criteria at the beginning of the study
Husband
Tobacco smoking, drug user, alcohol consumption or psychoactive drug; Mental problem history; happening stressful events during the past 6 months; Takes medicine affecting on mental health; Has sexually transmitted disease; Taking medications effecting sexual function; Does have vaginal intercourse due to hit in pelvic area or penis deformity.
Exclusion criteria during the study
Husband
Lack of tendency to continue his cooperation; Incomplete questionnaires; Occur stressful event during the study.
Age
From 18 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
256
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.MUMS.REC.1395.64
Health conditions studied
1
Description of health condition studied
Effectiveness of counseling pregnant women on quality of sexual life and sexual satisfaction couples in pregnancy
ICD-10 code
F52
ICD-10 code description
sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual satisfaction
Timepoint
Before the intervention and 2 and 4 weeks after begining of intervention
Method of measurement
Larson sexual satisfaction questionnaire (LSSQ)
2
Description
Quality of sexual life
Timepoint
Before the intervention and 2 and 4 weeks after begining of intervention
Method of measurement
Quality of sexual life questionnaire (SQOL)
Secondary outcomes
empty
Intervention groups
1
Description
Before intervention, Quality of sexual life (SQOL-F) and sexual satisfaction questionnaire(LSSQ) will be filled in by intervention group. two sessions (60 to 90 minutes) will be held by a midwife researcher based on PLISSIT model with one week gap. A Consultant starts her speech by asking some open question about sexual satisfaction. Then pregnant woman begins to speak. Therefore, consultant will be aware of her mistake thought, false belief, incomplete information and worries. In addition, using a few pictures will be helpful to explain anatomy and physiology of the reproductive system. A midwife provides consultation for all members of intervention group. Educational booklet will be given to the spouses of intervention group including anatomy and physiology of the reproductive system, and information and recommendation about pregnancy sex issues. Quality of sexual life and sexual satisfaction will be evaluated two and four weeks after intervention.
Category
Behavior
2
Description
Routine care consultation will be provided for control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Daneshamooz health center
Full name of responsible person
Zamani
Street address
Daneshamooz10 St, Vakil Abad Blvd
City
Mashhad
2
Recruitment center
Name of recruitment center
Kargaran health center
Full name of responsible person
Najmeh Dehlari
Street address
Chaman Blvd, Nakhrisi St
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, Daneshgah St
City
Mashhad
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, Vice chancellor for research
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
School of Nursing and Midwifery
Full name of responsible person
Najmeh Dehlari
Position
Master of cunseling in Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+95 5138477339
Fax
Email
dehlarin921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Khadijeh Mirzaii Najmabad
Position
PhD Reproductive Health
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
00
Fax
Email
mirzaiikh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Health Public
Full name of responsible person
Maryam Alizadeh
Position
Master of Biostatistics
Other areas of specialty/work
Street address
Daneshgah18 St
City
Mashhad
Postal code
Phone
+98 51 3852 8512
Fax
Email
alizadehm931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)