]>
IRCT20100510003902N5 IRCT 2024-08-17 Babol University of Medical Sciences The effect of chewing gum on the severity of labor pain The effect of chewing gum on the severity of labor pain in primiparous women 2021-05-01 anticipated 116 Complete https://irct.ir/trial/78404 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Our sample size was 116 people, of which 58 people were placed in each group. The block random allocation method was designed by the project collaborator using Stata version 15 software. The number of considered blocks is 6. The concealment process of random assignment (Concealment): The list of random allocation of patients was only available to the collaborator of the project. In order to hide the random allocation process, the order of treatments was written on 116 cards based on the randomized list, and only the project associate was aware of the relevant coding. When the obstetrician and gynecologist announced the eligibility of a patient, the colleague will provide the plan for the type of interventions for the primiparous mother. Blinding: Due to the treatment methods of the two groups, blinding is not possible and the design is open label. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the performed processes was used. N/A Condition 1: Anxiety. Condition 2: labor pain. Intervention 1: Intervention group: Chewing gum was done three times in the active state (expansion of 3-5 cm), the second (expansion of 5-7 cm) and the third time of expansion of 8-10 cm) each stage of labor was performed for 20 minutes. Intervention 2: Control group: In the control group, routine prenatal care and emphasis on not using gum during labor. 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 There is no further information
public Farideh Mohsenzadh Ledari
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 5323 Mohsenzadh2008@gmail.com Babol University of Medical Sciences scientific Farideh Mohsenzadh Ledari
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 5323 Mohsenzadh2008@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Primiparous women with a gestational age of 38-42 weeks based on LMP or ultrasound less than 26 weeks Pregnant women whose labor started spontaneously Live pregnancy A singleton fetus Having consent to enter the study Pregnant women without any complications that may cause dystocia during childbirth. Able to chew gum Cephalic presentation no limit no limit Female Women with chronic diseases vaginal bleeding Abnormal heartbeat of the fetus fetal abnormality Use of anesthesia and anesthesia in the first stage of childbirth Using other methods of childbirth analgesia History of mental illness (depression and stress) The recent death of a family member A history of a problem in one of the person's relatives due to natural childbirth drug use by the mother mother of a professional athlete Unwillingness to continue cooperation Anxiety di F41.9 Treatment - Other Treatment - Other Intervention group: Chewing gum was done three times in the active state (expansion of 3-5 cm), the second (expansion of 5-7 cm) and the third time of expansion of 8-10 cm) each stage of labor was performed for 20 minutes. Control group: In the control group, routine prenatal care and emphasis on not using gum during labor Primary outcome: labor pain. Timepoint: before the start of the intervention, in the latent phase (3-4 cm), in the active phase (5-7 cm) and the transfer phase of the librarian (8-10 cm) after chewing the gum. Method of measurement: Form VAS for participants. Anxiety. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Spielberger questionnaire. Babol University of Medical Sciences Approved 2021-05-01 Babol University of Medical Sciences (Biomedical Research Ethics Committee) Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)