Objective:: The effect of sexual training on sexual satisfaction of infertile women based on the sexual health model.
Design: The study was a randomized clinical trial with two groups of experimental and control. It was conducted single blind using pretest-posttest design.
Implementation: We used non-probability sampling and infertile women who were under treatment in Milad Infertility Center of Mashhad were allocated to the experimental and control group randomly. There were 54 subjects within each group, and random allocation was used to form 5-8 persons groups in the experimental group.
Inclusion criteria: Being Iranian, age 18 to 40 years.
Exclusion criteria: Withdrawing from the study for any reason and canceling treatment cycle.
Intervention: three 90-minute training sessions were held for experimental group during a month based on sexual health model. In current study, we used demographic characteristics questionnaire, Depression, Anxiety and Stress Scales (DASS-21) and also the Golombok Rust Inventory of Sexual Satisfaction (GRISS-F). After obtaining written consent from all subjects, pretest was conducted. There was no intervention in control group. After a month, posttest was given both groups by a research assistant who was unaware of allocation method. Then information was analyzed. In addition, training pamphlets were given to the control group at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102724469N2
Registration date:2017-03-13, 1395/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-13, 1395/12/23
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
Vice chancellor for research Mashhad University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual training on sexual satisfaction of infertile women based on sexual health model
Public title
The effect of sexual training on sexual satisfaction of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being Iranian and Muslim; literacy; giving a written consent; 18 to 40 years; living with husband at the moment and at least for one year; being the only wife for her husband; having official marriage; having vaginal intercourse; infertility acknowledgement by gynecologist; earning less than 75% of total score in the Golombok Rust Inventory of Sexual Satisfaction (GRISS-F); having a phone number.
Exclusion criteria in the beginning of the study: Taking medicine affecting sexual function; happening stressful events during the past 6 months for any of couples; being under psychiatric treatment for mental disorders; having severe depression; drug or alcohol addiction in any of couple; having an adopted child; having major conflicts with husband; studying books or consulting about sexual issues during the past 6 months; studying books or consulting about marital relations during the past 6 months; being under treatment for sexual dysfunction in any of couple or taking medicine lead to change in sexual desire during the past 3 months.
Exclusion criteria during the study: No tendency to cooperate with research team; not having sex until posttest; occurring stressful event during the intervention; receiving sexual training during the intervention; being absent for one session or more.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
54 subjects were allocated to each group of intervention and control randomly. For this purpose, folded bits of paper labeled "intervention" and "control" were utilized. We wanted qualified individuals to pick one paper out of a receptacle. The label on the paper showed sampling group, and that was continued until completion of the sample size.
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
2016-05-28, 1395/03/08
Ethics committee reference number
IR.MUMS.REC.1395.116
Health conditions studied
1
Description of health condition studied
The effect of sexual training on infertile women's sexual satisfaction
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
sexual satisfaction
Timepoint
َ1 month Before the intervention, 1 month After the intervention
Method of measurement
Golombok John Rust Sexual satisfaction questionnaire (Griss-F)
Secondary outcomes
1
Description
stress ,anxiety ,depression
Timepoint
َBefore the intervention, After the intervention
Method of measurement
stress ,anxiety and depression questionnaire(DASS21)
Intervention groups
1
Description
Three 90-minute sessions were held in Milad Infertility Center of Mashhad during a month. Aims of the study were explained in the first 10 minutes of each session and questions about sexual issues were stated. In the next 60 minutes, individuals received training by speech using the slide show. The last 20 minute was allocated to question and answer and also to resolve ambiguity by a psychologically trained researcher.
The content of first session was included sex, sexual anatomy and its function and sexual health challenges. Sexual identity, sexual health care, safe sex and positive sexual relationships were discussed in the second session, and the third session was about body image, sexual fantasies, relationships, intimacy and spirituality.
Category
Behavior
2
Description
There was no intervention in the control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Milad
Full name of responsible person
Firoozeh Shafighi
Street address
Akhoond Khorasani, Mashhad
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, University 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
Nahid Marvi
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
+98 51 4225 1361
Fax
Email
nahid.marvi1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Nahid Golmakani
Position
Master of Science in Midwifery
Other areas of specialty/work
Street address
Doktora Crossroads, Ebne Sina St, Mashhad Faculty of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3852 8512
Fax
Email
Golmakanin@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Health
Full name of responsible person
Maryam Alizadeh
Position
Master of Biostatistics
Other areas of specialty/work
Street address
daneshgah18, Daneshgah st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3259 2688
Fax
Email
alizadehm931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)