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IRCT20120718010324N67 IRCT 2021-06-08 Tabriz University of Medical Sciences The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women: a triple-blind randomized controlled trial 2021-05-30 anticipated 60 Complete https://irct.ir/trial/53766 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups (one group receiving Nigella Sativa oil and one group receiving placebo oil with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the Nigella Sativa oil and placebo oil will be placed in the same packages numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Urinary incontinence. Intervention 1: Intervention group will receive Nigella Sativa oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The oil will be provided by Barij Essence Pharmaceutical company. Intervention 2: Control group will receive placebo oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The placebo oil will be provided by Barij Essence Pharmaceutical company. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential.
public Afsaneh Alizadeh
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5714783449 +98 44 3385 9002 afsanehalizadeh072@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 57147834449 +98 44 3385 9247 mirghafourvand@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 45-60 age group Passing one year from the last menstrual period after the onset of normal menopause Not taking of drugs to treat urinary incontinence Achieving a score of four and higher according to the first three questions of the Questionnaire for Urinary Incontinence (QUID) Having a contact number to follow-up Living in the city of Tabriz Having a record in the health center (SIB system) Achieving a score of six and higher according to the second three questions of the QUID Not taking of tobacco and alcohol 45 years 60 years Female Having a history of any physical or mental illness that causes urinary incontinence Using other medications or traditional medicine to treat urinary incontinence Presence of urinary tract infection Allergy to Nigella Sativa Using of biofeedback to treat urinary incontinence N39.4 Other specified urinary incontinence Treatment - Drugs Placebo Intervention group will receive Nigella Sativa oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The oil will be provided by Barij Essence Pharmaceutical company. Control group will receive placebo oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The placebo oil will be provided by Barij Essence Pharmaceutical company. Urinary incontinence score. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Urine Incontinence Questionnaire. Score of urinary incontinence specific quality of life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Incontinence Quality of Life Instrument. Score of Menopause Specific Quality of Life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Menopause Specific Quality of Life Questionnaire. Sexual function score. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Female Sexual Function Index. Level of satisfaction with the received intervention. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: This variable will be measured using an item based on the Likert scale from very satisfied to very dissatisfied. Side events Including pain at the site of drug use, skin complications, increased heart rate, headache and other side events reported by the participant. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil and during the intervention through participants' report. Method of measurement: This variable will be measured using a side events checklist designed by the researcher. Tabriz University of Medical Sciences Approved 2021-05-01 Ethics Committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)