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IRCT20200808048334N1 IRCT 2021-03-01 Oroumia University of Medical Sciences Investigating effect of virtual reality Game Therapy on fear of child birth Investigating effect of virtual reality Game Therapy on fear of child birth in primiparous women referring to perinatal clinic of Emam Khomeini hospital in Mahabad in 2021 2020-09-22 anticipated 130 Recruiting https://irct.ir/trial/50608 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be divided into two groups of intervention and comparison by Blocked Randomization method. In this study, the allocation of two groups of intervention and comparison will be such that all possible modes for placing the letters A and B in the four blocks will be considered, which includes a total of 6 modes. These 6 modes are numbered from 1 to 6 and the required number of 4 blocks will be determined based on the number of samples studied. Then we will line up the required number, a random number based on a table of random numbers in a row: Of course, numbers above 6 will not be considered. Finally, based on the order of the numbers extracted from the table, the blocks related to each number will be listed in order, and when the samples are entered into the study, each person will take a specific letter in the order obtained. For example, according to the order (AABB / ABAB), the 5th person will be in group A. N/A Condition 1: Fear of childbirth. Condition 2: Childbirth pain. Intervention 1: Intervention group: Fear questionnaire and pain intensity measurement scale (research tools) will be completed at the beginning of the active phase of labor (4 cm dilatation) for both groups, then the virtual reality headset will be available to the intervention group after entering the active phase of labor and regular uterine contractions Will be inserted (The virtual reality headset is a 3D glasses that the mother is asked to wear, while wearing glasses, a game begins in three-dimensional space. The game called "Snow World" is designed in such a way that there is a black dot on the scene that we ask the mother to mark that point on the snowmen and earn points with each correct marking. It's just a fun game and can be stopped whenever the mother feels tired.) depending on the participant's wishes, but the minimum time to use the headset will be 20 minutes until the end of the first stage of labor (10 cm dilation) By entering the active phase of labor, pain and fear of childbirth in several stages, during the first stage, labor will be evaluated in dilatations of 4-6-8-10 cm. Intervention 2: Control group: Routine delivery care for mothers and infants in the control group will be performed in accordance with the hospital routine. 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 The research team will decide on the publication of participants' data after the end of the study
public Halime Mohammadi
No. 6, West imam khomeini hospital., Mahabad town
Mahabad Iran (Islamic Republic of) 5913754841 +98 44 4222 6155 mid.asrin.m@gmail.com Tehran University of Medical Sciences scientific Elham Ebrahimi
Nosrat st. Tohid sq. Tehran I.IRAN
Tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 Ebrahimi_308@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Primiparous women Gestational age 37 weeks and older single pregnancy Women 18 to 45 years old 18 years 45 years Female Primiparous women with twin pregnancies and more Illiterate women Women with vision or hearing problems Women with chronic diseases History of mental illness F40.232 G89.18 Fear of other medical care Other acute postprocedural pain Prevention N/A Intervention group: Fear questionnaire and pain intensity measurement scale (research tools) will be completed at the beginning of the active phase of labor (4 cm dilatation) for both groups, then the virtual reality headset will be available to the intervention group after entering the active phase of labor and regular uterine contractions Will be inserted (The virtual reality headset is a 3D glasses that the mother is asked to wear, while wearing glasses, a game begins in three-dimensional space. The game called "Snow World" is designed in such a way that there is a black dot on the scene that we ask the mother to mark that point on the snowmen and earn points with each correct marking. It's just a fun game and can be stopped whenever the mother feels tired.) depending on the participant's wishes, but the minimum time to use the headset will be 20 minutes until the end of the first stage of labor (10 cm dilation) By entering the active phase of labor, pain and fear of childbirth in several stages, during the first stage, labor will be evaluated in dilatations of 4-6-8-10 cm. Control group: Routine delivery care for mothers and infants in the control group will be performed in accordance with the hospital routine Fear of childbirth. Timepoint: The fear of childbirth questionnaire will be evaluated at the beginning of the active phase of labor (dilation of 4 cm) and by entering the active phase in several stages, during the first phase of labor in dilatations of 4-6-8-10 cm. Method of measurement: Childbirth Attitude Questionnaire. Childbirth pain. Timepoint: Childbirth pain questionnaire at the beginning of the active phase of labor (dilatation 4 cm) and entering the active phase in several stages, during the first phase of labor in dilatations of 4-6-8-10 cm will be evaluated. Method of measurement: The visual scale for measuring pain intensity is a 10 cm ruler with the word painless written on the left end and the most severe pain on the right end. Childbirth Self‐Efficacy. Timepoint: Childbirth Self‐Efficacy Inventory at the beginning of the active phase of labor (dilatation 4 cm) and entering the active phase in several stages, during the first phase of labor in dilatations of 4-6-8-10 cm will be evaluated. Method of measurement: Childbirth Self‐Efficacy Inventory. Oroumia University of Medical Sciences Approved 2020-12-22 Ethic commitee of Tehran University of Medical Sciences University of Nursing and Midwifery and Faculty of Rehabilitation - Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)