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IRCT20150128020854N7 IRCT 2019-09-30 Shahid Beheshti University of Medical Sciences Effect of kegel exercise and lubricant gel on the sexual function Comparison of the effect of kegel exercise and lubricant gel on the sexual function of menopausal women 2019-06-22 anticipated 150 Complete https://irct.ir/trial/40878 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: From the 7 health care centers in Dezful city, five centers will be randomly selected. Then postmenopausal women covered by these centers will be contacted and invited to participate in the study. Eligible women will be divided into three groups of 50 based on the random number table. In this way, all participants will be given three-digit codes from 001 to 150. Then, using the website www.Randomization.com, the statistical consultant will provide three sets of codes for researcher, the first in the intervention group with kegel, the second in the intervention group with lubricant gel, and the third in the control group. N/A sexual function. Intervention 1: In the Kegel intervention group, in a 60-minute session, a brief introduction to the anatomy and function of the pelvic floor muscles, an introduction to how the Kegel exercise is performed, its mechanism and function, its benefits, and finally an evaluation of participants to ensure that the exercise is performed properly will be done. PowerPoint, replica pelvis and movies will be used through individually and face-to-face teaching. A daily checklist (three times daily in the morning, noon, night) for 12 weeks as well as a Kegel Exercise Training Guide will be given to the participants as a pamphlet and then weekly follow up by telephone is performed. Intervention 2: In the intervention group with lubricant gel 45 minutes training session will be held for familiarizing with pelvic anatomy, pelvic floor muscles, vaginal and genitalia changes in menopause, lubricant gel and its benefits and how to use it is performed and finally evaluation of participants for learning materials will be done. Participants will be asked to record the frequency of using lubricant gel in their checklists for 12 weeks and will be followed up weekly by phone for investigation any reaction and side effects of lubricant gel and possible questions. Intervention 3: Control group: The control group will not receive any intervention and will solely receive general menopausal care. Demographic questionnaire and sexual function questionnaire will be completed with 12 weeks interval. No - There is not a plan to make this available Justification or reason for not sharing IPD is All the data will be published in tables in the final paper.
public Atefeh Khosravi
Vali-Asr cross of Niyayesh
Tehran Iran (Islamic Republic of) 198571443 +98 61 3632 3587 atefeh.khosravi120@gmail.com Shahid Beheshti University of Medical Sciences scientific Hedyeh Riazi
School of nursing and midwifery, Valiasr ave.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 h.riazi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Physiologic menopause (not due to surgery or premature menopause before 40 years of age) Being in the first 10 years of menopause Lack of self-reported medical diseases affecting sexual function (respiratory and cardiovascular disease, arthritis, Parkinson's disease, or multiple sclerosis) Lack of any self-reported psychological disease Absence of depression, anxiety, or stress based on the Depression Anxiety Stress Scales (DAAS) Scoring 2 or higher on the Oxford Grading Scale (OGS) for pelvic-floor muscle strength having sexual function Absence of impotence in the spouse (as declared by the participant) Not taking any herbal medicine containing phytoestrogen or any form of hormone replacement therapy Not taking any medicine affecting sexual function Negative history of hysterectomy and mastectomy Maximum five vaginal delivery Lack of self-reported genital infections Using lubricant gel in all the sexual intercourses in lubricant gel intervention group) no limit no limit Female Unwillingness to cooperating in the study. Allergy to lubricant gel. F52.9 Unspecified sexual dysfunction not due to a substance or known physiological condition Behavior Behavior N/A In the Kegel intervention group, in a 60-minute session, a brief introduction to the anatomy and function of the pelvic floor muscles, an introduction to how the Kegel exercise is performed, its mechanism and function, its benefits, and finally an evaluation of participants to ensure that the exercise is performed properly will be done. PowerPoint, replica pelvis and movies will be used through individually and face-to-face teaching. A daily checklist (three times daily in the morning, noon, night) for 12 weeks as well as a Kegel Exercise Training Guide will be given to the participants as a pamphlet and then weekly follow up by telephone is performed. In the intervention group with lubricant gel 45 minutes training session will be held for familiarizing with pelvic anatomy, pelvic floor muscles, vaginal and genitalia changes in menopause, lubricant gel and its benefits and how to use it is performed and finally evaluation of participants for learning materials will be done. Participants will be asked to record the frequency of using lubricant gel in their checklists for 12 weeks and will be followed up weekly by phone for investigation any reaction and side effects of lubricant gel and possible questions. Control group: The control group will not receive any intervention and will solely receive general menopausal care. Demographic questionnaire and sexual function questionnaire will be completed with 12 weeks interval. Sexual function. Timepoint: Before intervention, one, two and three months after intervention. Method of measurement: ّFemale Sexual function questionnaire (FSFI). Shahid Beheshti University of Medical Sciences Approved 2017-07-18 Shahid Beheshti Univercity of Medical Sciences, School of Nursing and Midwifery Vali Asr Ave, Niayesh Cross Road, SBMU School of Nursing & Midwifery Tehran Tehran Iran (Islamic Republic of)