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IRCT20220701055331N5 IRCT 2025-03-27 Rashid latif medical college COMBINED EFFECTS OF PELVIC FLOOR ACTIVATION EXERCISESAND BENSON RELAXATION TECHNIQUE ON PAIN, URINARYINCONTINENCE AND FUNCTIONAL ABILITY AMONG POST–CESAREAN PATIENTS COMBINED EFFECTS OF PELVIC FLOOR ACTIVATION EXERCISES AND BENSON RELAXATION TECHNIQUE ON PAIN, URINARY INCONTINENCE AND FUNCTIONAL ABILITY AMONG POST– CESAREAN PATIENTS 2025-03-25 anticipated 60 Complete https://irct.ir/trial/82524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random computer number generator will be used for randomization. Assign unique identification numbers to participants, then use a reliable software tool to generate a list of random numbers. Match these numbers to participant IDs and allocate individuals to different study groups based on the sorted random numbers. Ensure that the randomization process is concealed and documented for transparency and integrity, Blinding description: Single blinding in a study involves keeping the outcome assessor blind to the intervention received by the participants. This helps to minimize bias in assessing the study outcomes. To achieve single blinding, the outcome assessor is not informed about the treatment allocation of the participants and remains unaware of which group received the intervention being studied. N/A Post-Cesarean Patients. Intervention 1: Intervention group: Pelvic floor activation exercises with Benson relaxation technique. It will be performed for 4 weeks and five times in a week. Intervention 2: Intervention group: Pelvic floor activation exercises. It will be performed for 4 weeks and five times in a week. 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 concerns about patient confidentiality and privacy, uncertainty about the legal and ethical implications of sharing sensitive data, lack of resources or infrastructure to manage and share the data securely, and potential risks of misinterpretation or misuse of the data by third parties
public Malaika Sajid Sidhu
35-km ferozepur road lahore
lahore Pakistan 54600 +92 304 3044494 malaikasidhu@gmail.com Rashid latif medical college scientific Ifra Zulqarnain Awan
Rashid Latif Medical College 35-km Ferozpur Road Lahore
Lahore Pakistan 54600 +92 333 4975431 ifra.awan@rlmc.edu.pk Rashid Latif Medical College Pakistan Women aged 20 to 42 at 7 to 14 weeks after delivery or cesarean sectionExperiencing pain in the pelvic region post-cesarean section. Patient's BMI did not surpass 30 kg/m2 primiparous and mild-degree SUI Presented with symptoms of urinary incontinence Patients who were not currently undergoing any other specific pelvic floorrehabilitation program. 20 years 42 years Female Individuals with cognitive impairments or communication difficulties that may hinderparticipation in the study. Patients with active infections or complications related to the cesarean section incisionsite. Patients with severe medical conditions that may limit their ability to perform theprescribed exercises or relaxation techniques. Patients undergoing treatment for pelvic floor issues with interventions that mayinterfere with the study outcomes. presence of hypertension, diabetes, genital prolapse,and smoking. Rehabilitation Rehabilitation Intervention group: Pelvic floor activation exercises with Benson relaxation technique. It will be performed for 4 weeks and five times in a week. Intervention group: Pelvic floor activation exercises. It will be performed for 4 weeks and five times in a week. Pain. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Numeric pain rating scale to measure pain. Urinary incontinence. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: International Consultation on Incontinence Questionnaire-UrinaryIncontinence Short Form (ICIQ-UI SF). Functional ability. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Functional Independence Measure (FIM). Rashid Latif Medical College Approved 2024-09-26 Institutional Review Board of Rashid Latif Medical College, Lahore. 35-KM Ferozepur Road Lahore Lahore Punjab Pakistan