Determining the effectiveness of pelvic floor muscle exercise in primiparous women with postpartum sexual dysfunction
Design
This study is a randomized controlled trial.
Settings and conduct
Cluster random sampling was performed in several health centers in Babol city.
Participants/Inclusion and exclusion criteria
Inclusion in the study: Primiparous women who had a normal delivery or cesarean section 3 to 6 months ago. Ability to read and write, to have sustained sexual activity for at least the last four weeks, to have breastfeeding, to have a sexual function score (FSFI) of less than 26.5
Not included in the study: history or having severe psychiatric disorders, history or having physical illness, users of drugs that cause sexual dysfunction, experience of a stressful event in the last trimester, women who had a traumatic delivery with severe perineal rupture, women who their spouse has masculine factors of sexual dysfunction.
Intervention groups
Intervention group: Kegel exercises and training on how to do it and continue for 8 weeks
Control group: Breastfeeding training and its different positions and related training according to the national protocol for breastfeeding promotion
Main outcome variables
Improvement of Female Sexual Function Index after the intervention was the main variable
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046228N2
Registration date:2020-12-02, 1399/09/12
Registration timing:retrospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-29, 1398/07/07
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2019-10-02, 1398/07/10
Actual recruitment end date
2020-01-21, 1398/11/01
Trial completion date
2020-04-08, 1399/01/20
Scientific title
The effect of pelvic floor muscle exercises on postpartum sexual function in primiparous women with impaired sexual function
Public title
The effect of pelvic floor muscle exercises on postpartum sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women had normal or cesarean delivery three to six months prior to the commencement of the study.
Primiparous women aged 18 to 40.
Women are literate (can at least read and write).
Women have sexual intercourse with their husbands regularly at least during the last four weeks.
Women have breastfeeding.
Women have a total Female sexual function index (FSFI) score less than 26.5, which is the cutoff score for diagnosing female sexual dysfunction according to the reference.
Exclusion criteria:
Women with severe psychiatric disorders including severe depression, psychotic disorder and bipolar disorder
Women with history of drug abuse
Women with chronic conditions
Women who take drugs such as barbiturates, benzodiazepine, antidepressants, and antihypertensive which cause sexual dysfunction.
Women who have experienced a stressful event over the last three months (death or acute illness of close family members or relatives, or major change in lifestyle).
women who have had a traumatic delivery with severe perineal laceration.
Women whose husbands have male factors of sexual dysfunction.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After checking inclusion and exclusion criteria, participants are randomly allocated to two groups using permuted block randomization. The size of each permuted block is four and 20 of them will be produced using the statistical software. Since the sampling is performed in four different centers and an allocation ratio of 1: 1 to two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the samples were selected from four comprehensive health centers of the city of Babol using cluster sampling. Before the intervention, the weight and height of the eligible women were measured. Then their social and demographic characteristics were recorded and they completed the female sexual function index (FSFI) questionnaire. After that, the samples were randomly assigned to two groups using permuted block randomization. The intervention group was divided into groups of 8 to 12 and each group received two face-to-face training sessions every week for two weeks. Each session was held for 120 minutes and the participants were taught the anatomy and physiology of the reproductive system in men and women, the male and female sexual response cycle, the stages of sexual function, and how to perform pelvic floor exercises (once a week). The correct way to do the Kegel exercise is to do 10 contractions of one to three seconds and then take a rest for three seconds. The number and duration of contractions should then increase gradually based on one’s ability in a way that they will be able to do 90 to 100 contractions per day and each contraction should last for five minutes followed by a 5-minute rest. On the other hand, just the same as the intervention group, the control group was divided into groups of 8 to 12 and the members received two 120-minute face-to-face training sessions per week for two weeks. In these sessions, the participants were given lessons about breastfeeding and its different positions and techniques according to the national protocol for promoting breastfeeding. The necessary follow-ups were performed on a weekly basis for both groups through a phone call made by the midwife of each center for at least six weeks. A checklist for recording the daily exercises was also given to the participants to help them provide an accurate weekly report and facilitate further review. The total duration of the treatment was eight weeks (two weeks of training and six weeks of follow-up). At the end of the study, training manuals on sexual function and pelvic floor exercises were provided for the control group. In the intervention group the eligible women were trained to do the pelvic floor exercises. In this regard, they were taught the correct ways to perform Kegel exercises using verbal explanations, pictures and videos. They were also given checklists for their daily exercises. The control group received two 120-minute training sessions every week in breastfeeding and different breastfeeding positions according to the national protocol for promoting breastfeeding.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.MUBABOL.HRI.REC.1398.244
Street address
Faculty of Medicine, Department of Midwifery, University of Medical Sciences, Ganj Afrooz St., Babol, IRAN
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.244
Health conditions studied
1
Description of health condition studied
Postpartum female sexual dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Female Sexual Function Index
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the localized standard questionnaire, it is the index of female sexual function, which is the cut-off point for the existence of a score disorder of 26.5.
Secondary outcomes
1
Description
A secondary consequence of this study is the reduction of urinary stress incontinence
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence
Intervention groups
1
Description
Intervention group: Intervention group: Eligible women were trained to do the pelvic floor exercises. In this regard, they were taught the correct ways to perform Kegel exercises using verbal explanations, pictures and videos. They were also given checklists for their daily exercises
Category
Treatment - Other
2
Description
Control group: received two training sessions every week in breastfeeding and different breastfeeding positions according to the national protocol for promoting breastfeeding. Duration of each session was 120 minutes
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service center of Sultan Mohammad Taher
Full name of responsible person
Negar Akbari
Street address
Babol, Kiakla Road, Sultan Mohammad Taher Village, Comprehensive Health Center
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3207 2211
Email
negarakbari2510@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri- Amiri
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shanaz Barat
Position
Director of the Department of Obstetrics and Gynecology, School of Medicine
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Baol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8305
Email
a.ghanbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
32190597
Email
nasiri_fa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available