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IRCT20200118046170N3 IRCT 2021-06-29 Mazandaran University of Medical Sciences Effect of black seed oil on urinary incontinence Effect of topical black seed oil on urinary incontinence in elderly women 2021-06-22 anticipated 80 Complete https://irct.ir/trial/53416 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: • Permuted block randomization is designed to randomly assign participants to two intervention groups and the control group in equal numbers in each group using appropriate software. In this method, each block with a certain number is assigned to each group. Six possible combinations of group assignment (AABB, ABAB, BAAB, BABA, BBAA, ABBA) exist in quadruple blocks. Each time, the computer program randomly selects one of the scenarios and sets the order. For example, if the AABB mode is selected for the first time, the first and second persons will be in group A and the third and fourth persons will be in group B. Finally, the assignment of research units is determined in order for 80 samples. Thus, 80 opaque envelopes are prepared, which are numbered from 1 to 80. Based on computer results, the letter A or letter B is written inside each envelope. No one knows which group in the envelope belongs to. The secretary of the clinic opens the envelopes for the elderly in the order in which they visit, to place the people in their own designated group. Group A will be the intervention group and will receive the necessary interventions according to the protocol. The intervention in the control group is routine (using placebo). The evaluator is also unaware of the group assignment. , Blinding description: The random allocation and the administration of black seed oil and placebo oil to the samples will be performed by the secretary. Researchers and patients will be unaware of their own assignment to one of the two intervention or control groups. The lid of Firooz Baby Oil container (Oil for placebo) is impregnated with black seed oil. Both containers of oil (placebo and black seed) are similar. 3 Urinary incontinence. Intervention 1: Intervention group: The intervention group will apply 15 drops of black seed oil from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). Black seed oil will be prepared from Barij Essence Pharmaceutical Company. Intervention 2: Control group: The control group will apply 15 drops of Firooz Body Oil for Baby from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). Body oil will be prepared from Firooz Hygienic Group. 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 No more information
public Manizheh Zakizad Abkenar
Nasibeh Nursing and Midwifery School, Vesal Street
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7343 Zakizadeha@yahoo.com Mazandaran University of Medical Sciences scientific Manizheh Zakizad Abkenar
Nasibeh Nursing and Midwifery School, Vesal Street
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7343 Zakizadeha@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Normal cognitive status (obtaining a score of ≥7 based on cognitive assessment tools) History of mild to moderate urinary incontinence (obtaining a score of 1 to 12) Informed consent 60 years 80 years Female No history of taking medication for urinary incontinence during the two weeks before the intervention Absence of active urinary tract infection Absence of neurogenic disorders (multiple sclerosis, stroke and spinal cord injury) No history of pelvic surgery during the last year No bladder cancer Lack of hypersensitivity to vegetable oils Body mass index(BMI) less than 40 No history of skin disease in the sites of drug administration Absence of obsessive-compulsive disorder N39.46 Mixed incontinence Treatment - Drugs Placebo Intervention group: The intervention group will apply 15 drops of black seed oil from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). Black seed oil will be prepared from Barij Essence Pharmaceutical Company. Control group: The control group will apply 15 drops of Firooz Body Oil for Baby from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). Body oil will be prepared from Firooz Hygienic Group. Urinary incontinence. Timepoint: Before the intervention, after the third and sixth weeks of the intervention. Method of measurement: The questionnaire contains 6 questions, the first 2 questions are related to demographic information, and the rest examines the frequency of urine leakage (score 0 to 5), the rate of urine leakage (score 0 to 6), the effect of urine leakage on quality of life (score 0 to 10) and the time of urine leakage. No score is considered for the last question (35). The total score of the questionnaire is 21, and is divided into mild (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Urinary incontinence. Timepoint: Third and sixth week. Method of measurement: The questionnaire. Mazandaran University of Medical Sciences Approved 2020-12-29 Ethics committee of Mazandaran University of Medical Sciences Moalem Square. Deputy of research and technology. Mazandaran University of Medical Sciences. Sari Mazandaran Iran (Islamic Republic of)