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IRCT20190122042453N1 IRCT 2019-04-05 Boushehr University of Medical Sciences Investigating the effect of Reflexology and relaxation of Benson on pain, physiological symptoms, lactation and weight of newborn in women undergoing cesarean section Investigating the effect of Reflexology and relaxation of Benson on pain, physiological symptoms, lactation and weight of newborn in women undergoing cesarean section, admitted to Persian Gulf Shohada Hospital of Bushehr in 2018 2019-04-21 anticipated 135 Complete https://irct.ir/trial/38249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: ََAccording to block the research sample will be placed into one of the three groups of foot reflexology, Benson relaxation, or control group. The number of required blocks will be selected randomly. For blocking, 22 blocks of 6 blocks and a triple block will be used. Block size 6 and 3 will be used. In the first step, blocks size 6 are prepared using A (Reflexology), B (Benson relaxation intervention) and C (Control group), which will have 90 different modes.Of the blocks, 22 will be randomly selected. By selecting each six blocks, each one will be placed in one of three groups according to the order of the letters of the letters: each block will receive two chances for each group. Block size 3 will also be provided (6 modes) and one block will be randomly selected. N/A Condition 1: Pain. Condition 2: Physiological Index. Condition 3: Neonate weight. Condition 4: Breast feeding (number of times and mean times of breast feeding during 18 hours after c/s). Intervention 1: Intervention group: Benson's relaxation will be performed two hours after c/s and 6 hour after first episode of intervention. The duration of intervention will be 20 minutes each time. Then, the variables (physiological indices, pain) will be immediately measured 30 and 60 minutes after each intervention. The frequency of breastfeeding will be measured in 18 hours after the operation. On the day of surgery and ten days after the operation, the baby weight will be measured. Intervention 2: Control group: In this group no intervention will perform by researcher. Routine care will be provided by department personnel. The variables required for research will be measured parallel with two intervention groups. 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 Razieh Bagherzadeh
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St.
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0236 r.bagherzadeh@bpums.ac.ir Boushehr University of Medical Sciences scientific Razieh Bagherzadeh
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St.
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0236 r.bagherzadeh@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Having the consent to participate in the study Not an emergency Caesarean section Spinal anesthetics Gestational age at least 37 weeks and maximum 42 weeks according to the exact date of the first day of the last menstruation or first trimester ultrasound At least reading and writing skills Age range 18-35 Being aware of time and place No drug addiction, sedation, alcohol, etc. According to the self-declaration of the research unit Absence of any mental disorder due to the self-explanation of a research unit or a physical impairment affecting the sensation of the leg such as diabetes No history of using foot massage or relaxing Benson First or Second Pregnancy Having single-strike pregnancy and low risk Lack of simultaneous surgery such as hysterectomy and tuberculosis Having a healthy leg in the foot, especially The sole of the foot, (no cuts, burns, fungal infection, varicose veins, warts, corns and any kind of anesthetics in the feet, lack of sensitivity to touch or massage Failure to report congenital anomalies in patient's ultrasound The absence of pregnancy complications such as blood pressure Do not tear a sack of water 18 years 35 years Female Severe complications after surgery or during hospitalization such as severe bleeding, edema, acute infection and non-ablation of the uterus after surgery Incident in the operating room The need for more care in the intensive care unit Perform non-transverse cutting on the uterus or abdomen according to the description of the patient's operation Pain score below 3 at the time of the decision to intervene Cancellation of the continuation of the research Having an unpleasant participant's sensation of touching the foot in the Foot Reflexology massage group The hospitalization of newborns undergoing cesarean section in the NICU department There is any kind of disorder that causes the problem of infant feeding, such as Cleft palate and Lip are not detected,Galactosoma The occurrence of any problem in the mother that prevents lactation, such as unpleasant events, breast abscess, etc. (in this case, only the babies of these mothers will not be included in the study Treatment - Other N/A Intervention group: Benson's relaxation will be performed two hours after c/s and 6 hour after first episode of intervention. The duration of intervention will be 20 minutes each time. Then, the variables (physiological indices, pain) will be immediately measured 30 and 60 minutes after each intervention. The frequency of breastfeeding will be measured in 18 hours after the operation. On the day of surgery and ten days after the operation, the baby weight will be measured. Control group: In this group no intervention will perform by researcher. Routine care will be provided by department personnel. The variables required for research will be measured parallel with two intervention groups. Pain. Timepoint: Before intervention, immediately after intervention, 30 and 60 second after intervention. Method of measurement: Visual scale of pain,. Physiological symptoms (pulse, BP and O2 saturation). Timepoint: Before intervention, immediately after intervention, 30 and 60 second after intervention. Method of measurement: Barometer, Pulse oximetere. Breast feeding (number and mean of times of breast feeding during first 18 hours after birth). Timepoint: During 18 hours after c/s.To check the frequency and time of breastfeeding, a checklist is provided; each breastfeeding period and its duration up to 18 hours after cesarean section will be recorded by a researcher or nurse responsible for the baby. Method of measurement: Observation and statement by researcher and responsible nurse. Baby weight. Timepoint: The first and the tenth day after cesarean section. Method of measurement: Baby weighing scale. Boushehr University of Medical Sciences Approved 2019-03-11 Ethics Committee of Bushehr University of Medical Sciences Moallem St., Kuy-e-Bandar Bushehr Boushehr Iran (Islamic Republic of)