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IRCT20230710058736N1 IRCT 2023-10-22 Shahid Beheshti University of Medical Sciences Investigating the Effect of Hand Reflexology on Postpartum pain Investigating the Effect of Hand Reflexology on Postpartum Pain in Multiparous Women: A Randomized Controlled Clinical Trial Study 2023-11-22 anticipated 90 Complete https://irct.ir/trial/71294 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: It is accessible (simple) and goal-oriented. All patients who meet the conditions for entering the study are examined. Random Allocation of Samples will be done using Excel Software. Finally, People will be divided into 3 Groups: Verum Intervention (30 people), Sham Intervention (30 people) and Routine Care (30 people), Blinding description: The Research Unit will be Randomly assigned to 3 Groups: Verum Intervention, Sham Intervention and Routine Care Using Excel Software. The Verum and Sham Intervention Groups will be Fully Explained about the Objectives of the Research and not only about the Existence of the Routine Care Group, but also about the Fact that they may be Randomly Placed in one of the Two Verum Intervention Groups. The Sham Intervention is Similar to the Verum Intervention in every way, Including the Place, Time, Technique and Frequency of the Intervention, and the only Difference is in the Amount of Pressure Applied and thus Blinding. It is done because they do not know Exactly the Type of Intervention. One of the Limitations of the Research is the Detailed Explanation of the Objectives of the Research to the Routine Care Group. The Explanation to this Group is that the Study will be conducted with the Aim of Investigating the Severity of Postpartum Pain, and it is tried to Separate the Room of the Routine Care Group from the other Two Groups. Also, the Clinical Caregivers (Nurses and Midwives of the Post-Partum Department) and Gynecologists of the Center know about the Objectives of the Research, but they do not know the Type of Intervention Received by each Research Unit, in Fact, they do not know which Intervention each Person received. N/A Postpartum uterine pain. Intervention 1: Intervention group:Verum reflexology group in each hand, first, 3 minutes of massage, then the real reflection of the thumb and the researcher reflects the pressure snake in the heart reflection and the solar network and pressure with the Mole technique in the pituitary and uterine reflexion area, the pressure rate in the reflection areas is so high that the research unit does not feel pain and not in the third third of the thumb. The reflection time in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand. Intervention 2: Intervention group: Sham reflexology group in each hand, first, 3 minutes of massage, then the reflection of the shaped by the thumb and the researcher referring, the pressure of the snake in the reflective and distribution of the solar and the solar network, and the high-end system with the Mole technique in the pituitary and uterine reflexent region, the rate of pressure in reflective areas is so high that it does not create a color in the upper third thumb. The duration of the reflection of the sham in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand. Intervention 3: Control group: The routine care group receives only routine care after delivery. 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 Fateme Sahebi mofrad
Tehran, intersection of Ayatollah Hashemi Rafsanjani highway and Wali Asr street, Niayesh campus in front of Shahid Rajaei heart hospital, Faculty of Nursing and Midwifery
tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 safateme19@gmail.com Shahid Beheshti University of Medical Sciences scientific Fateme Sahebi mofrad
Tehran, intersection of Ayatollah Hashemi Rafsanjani highway and Wali Asr street, Niayesh campus in front of Shahid Rajaei heart hospital, Faculty of Nursing and Midwifery
tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 safateme19@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The Research Unit is willing to Participate in the Study Be Iranian Be 15-45 Years Old Body Mass Index is18/5-29/9 Be Multi-par Be Single Do not have a High-Risk Pregnancy (Pre-Eclampsia, Placental Abnormalities Such as Placental Abruption, Placenta Previa and Placenta Accreta, Chorioamnionitis and Diabetes with Insulin) The Presentation of the Fetus is Cephalic Natural Birth without Tools Do not have Abnormal Bleeding after Delivery The Baby's Weight Should be 2500-4000 Grams Wounds, Burns, Fungal Infections, Warts, Varicose veins, Thickening of Skin Layers, often Yellow in Color, Numbness, and in General, do not have any Lesions or Problems in the Hands Don't have Contagious Skin Disease on Hands such as Scabies, Chicken Pox, Jaundice He doesn't have Mental Problems and Anxiety, he doesn't use Drugs that Affect the Nervous System The Mother should not be Prohibited from Breastfeeding The Intensity of the Back Pain should be Mild to Severe According to the Numerical Rating Scale of Pain The Placenta and Membranes have not been Removed by Hand (Uterine Courage). 15 years 45 years Female The Research Unit does not want to Continue Participating in the Research Received Additional Treatments to Control Postpartum Bleeding (such as Oxytocin, Methylergonovine, Prostaglandin E1, Prostaglandin f2α, Blood Transfusion, Surgery) Uterine Curettage has been Performed During the Study The Mother is unable to Continue Breastfeeding Receive less than 2 Times Verum or sham reflexology Treatment - Other Placebo N/A Intervention group:Verum reflexology group in each hand, first, 3 minutes of massage, then the real reflection of the thumb and the researcher reflects the pressure snake in the heart reflection and the solar network and pressure with the Mole technique in the pituitary and uterine reflexion area, the pressure rate in the reflection areas is so high that the research unit does not feel pain and not in the third third of the thumb. The reflection time in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand Intervention group: Sham reflexology group in each hand, first, 3 minutes of massage, then the reflection of the shaped by the thumb and the researcher referring, the pressure of the snake in the reflective and distribution of the solar and the solar network, and the high-end system with the Mole technique in the pituitary and uterine reflexent region, the rate of pressure in reflective areas is so high that it does not create a color in the upper third thumb. The duration of the reflection of the sham in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand Control group: The routine care group receives only routine care after delivery Postpartum pain. Timepoint: Within 2 hours before the intervention, immediately after the intervention, within 30, 60, and 120 minutes after the intervention and 24, 48, and 72 hours after delivery. Method of measurement: Numerical rating scale is a tool to measure the intensity of pain, which is in the form of a 10 cm ruler with 11 numbers. Shahid Beheshti University of Medical Sciences Approved 2023-10-11 Ethics Committee of Faculty of Pharmacy and Midwifery Nursing, Shahid Beheshti University of Medical Block A, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamak and Zarafshan, Quds Town (West), Tehran. Tehran Tehran Iran (Islamic Republic of)