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IRCT20200122046228N2 IRCT 2020-12-02 Babol University of Medical Sciences The effect of pelvic floor muscle exercises on postpartum sexual function The effect of pelvic floor muscle exercises on postpartum sexual function in primiparous women with impaired sexual function 2019-09-29 anticipated 86 Complete https://irct.ir/trial/49675 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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. N/A Postpartum female sexual dysfunction. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Since it is about sexual function, and due to its confidentiality, there is no tendency to release the data.
public Fatemeh Nasiri- Amiri
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0597 nasiri_fa@yahoo.com Babol University of Medical Sciences scientific Shanaz Barat
Department of Obstetrics and Gynecology, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Baol Iran (Islamic Republic of) 4717647745 +98 11 3223 8305 a.ghanbar@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 40 years Female 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. Treatment - Other N/A 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 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 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. 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. Babol University of Medical Sciences Approved 2019-09-28 IR.MUBABOL.HRI.REC.1398.244 Faculty of Medicine, Department of Midwifery, University of Medical Sciences, Ganj Afrooz St., Babol, IRAN Babol Mazandaran Iran (Islamic Republic of)