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IRCT20180427039436N13 IRCT 2023-03-01 Iran University of Medical Sciences The effect of educational film on pre-cesarean anxiety and childbirth experience Investigating the Effect of Multimedia training on the Anxiety and Childbirth Experience of women with Planned Cesarean Section 2023-04-21 anticipated 140 Complete https://irct.ir/trial/68823 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The allocation of people in the test and control group will be done using the quadruple block method (probabilistic type) using the site http://randomization.com/. Blocking is such that in this study, with 140 sample people, 70 people will be allocated to each group (the test group is considered to be A and the control group is considered to be B). Two defaults are considered, the size of each block is at least twice the number of groups (4 groups in each block) and the number of repetitions of groups is equal. According to the sample size of 140 people and the size of each block is 4, finally 35 blocks will be obtained. Then, using the site http://randomization.com/, the order of placement of the blocks and as a result the people of the test and control group is determined using the software. In order to hide the random allocation process, the names of the groups will be placed in opaque envelopes, and these envelopes will be numbered from 1 to 140 and arranged in a box. The researcher who conducts the sampling is unaware of the contents of the envelopes. The content of the envelopes will indicate the study groups, and after entering the study and completing the informed consent form, the participants will pick the first envelope in order of number and according to the content of the envelope, they will be placed in one of the two test and control groups. N/A Condition 1: Anxiety. Condition 2: Childbirth Experience. Intervention 1: Intervention group: In this research, the content of the intervention will be prepared in the form of a 4-6 minute educational film based on the principles of Mayer's multimedia education in the form of video, animation, images in MPEG-4 (MP4) format, and after entering the study of the educational film individually It will be displayed for the mother on the researcher's laptop in the consultation room of the Perinatal Clinic of Akbarabadi Hospital. This video includes trainings for familiarizing women undergoing planned cesarean section with all aspects of cesarean section as well as preparation for the operation: definition of cesarean section and its common indications, real images with explanations of the mother's admission and hospitalization process in the hospital and staff. The Medical staff that the mother will probably face, pre-operative medical care, operating room, mother's position for spinal anesthesia, animation to explain the anatomy of spinal anesthesia, animation of surgical incision and delivery of the baby, skin-to-skin contact images of mother and baby , the recovery room after surgery and the recovery process in the hospital. This video does not contain blood images and the dangers of spinal anesthesia. The educational content of this video is based on the latest health guide and service standard "Routine midwifery care, including before delivery, cesarean delivery and post-cesarean care" (Secretariat of the Strategic Council for Compilation of Health Guides, 1400) and also based on the latest trainings of American College of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynecologists and National Health Service of England. Intervention 2: Control group: There is no intervention for the control 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 Due to the fact that the desired study and investigations have not been done, no decision has been made in this regard.
public Leila Amiri Farahani
In front of Khatamol anbiaa Hospital, Valiasr Ave., Rashid Yasemi Ave., Tehran town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 l.amirifarahani@gmail.com Iran University of Medical Sciences scientific Leila Amiri Farahani
In front of Khatamol anbiaa Hospital, Rashid yasemi Ave., Valiasr Ave., Tehran Town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 l.amirifarahani@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Being Iranian Women aged 18 to 45 Ability to read and write 18 years 45 years Female Suspicion of Congenital Anomaly of the Fetus Known Mental Disorder or History of Taking Anti-anxiety Medications and Sedatives History of Infertility F41.1 O00-O99 Generalized anxiety disorder Pregnancy, childbirth and the puerperium N/A N/A Intervention group: In this research, the content of the intervention will be prepared in the form of a 4-6 minute educational film based on the principles of Mayer's multimedia education in the form of video, animation, images in MPEG-4 (MP4) format, and after entering the study of the educational film individually It will be displayed for the mother on the researcher's laptop in the consultation room of the Perinatal Clinic of Akbarabadi Hospital. This video includes trainings for familiarizing women undergoing planned cesarean section with all aspects of cesarean section as well as preparation for the operation: definition of cesarean section and its common indications, real images with explanations of the mother's admission and hospitalization process in the hospital and staff. The Medical staff that the mother will probably face, pre-operative medical care, operating room, mother's position for spinal anesthesia, animation to explain the anatomy of spinal anesthesia, animation of surgical incision and delivery of the baby, skin-to-skin contact images of mother and baby , the recovery room after surgery and the recovery process in the hospital. This video does not contain blood images and the dangers of spinal anesthesia. The educational content of this video is based on the latest health guide and service standard "Routine midwifery care, including before delivery, cesarean delivery and post-cesarean care" (Secretariat of the Strategic Council for Compilation of Health Guides, 1400) and also based on the latest trainings of American College of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynecologists and National Health Service of England. Control group: There is no intervention for the control group. Anxiety score in the state section of the Spielberger Anxiety Questionnaire. Timepoint: When entering the study, 30 minutes after the intervention in the perinatal clinic of the hospital, 30 minutes after being admitted to labor on the day of the operation and the evening of the day after the cesarean section. Method of measurement: State section of the Spielberger Anxiety Questionnaire. Childbirth Experience Score in the Questionnaire for Assessing the Childbirth Experience. Timepoint: The evening of the day after cesarean section. Method of measurement: ُShort version of Questionnaire for Assessing the Childbirth Experience. Overall satisfaction score for cesarean delivery. Timepoint: The evening of the day after cesarean section. Method of measurement: A general question about overall satisfaction with cesarean delivery in a demographic-midwifery researcher-made questionnaire in which the mother rates her satisfaction with anesthesia and cesarean delivery from 1 to 10. Iran University of Medical Sciences Approved 2023-02-22 Ethics committee of Iran University of Medical Science Next to Milad Tower, Hemet Highway, Tehran Tehran Tehran Iran (Islamic Republic of)