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
Determining the effect of virtual reality-based play therapy on the severity of fear of childbirth in nulliparous women referred to the prenatal clinic of Emam Khomeini hospital in Mahabad in 2021
Design
A clinical trial with a control group, with parallel groups of 130 participants and allocating 65 people in the intervention group and 65 people in the control group randomly using block randomization method.
Settings and conduct
Research environment: Imam Khomeini Hospital, Mahabad
Research population: All nulliparous women referred to the prenatal clinic of Imam Khomeini Hospital in Mahabad
Research examples: Primiparous women with inclusion criteria
Samples with inclusion criteria are selected by random sampling method.
Participants/Inclusion and exclusion criteria
Major Inclusion criteria: Willingness to participate in the study, Nulliparous women; Gestational age 37 full weeks of pregnancy and above, age 18 to 45 years of mother, single pregnancy Etc. Major non-entry criteria :Women with previous pregnancy experience, Primiparous women under 37 weeks of gestation, Twin pregnancies and more, Women under 18 and over 45 years.
Intervention groups
Intervention group: The virtual reality headset will be provided to the members of the intervention group after entering the active phase of labor and regular uterine contractions as many times as the participant wants. It depends, but the minimum time to use the headset will be 20 minutes until the end of the first stage of labor (10 cm dilation) .
Control group: do not receive any intervention and receive routine care according to the hospital routine.
Main outcome variables
The main variable in the present study is the fear of childbirth. In this study, the degree of fear of childbirth means the score that pregnant women gain before and after the intervention based on the Harman fear of childbirth questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200808048334N1
Registration date:2021-03-01, 1399/12/11
Registration timing:registered_while_recruiting
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
halime Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4222 1227
Email address
mid.asrin.m@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2641-12-22, 2020/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating effect of virtual reality Game Therapy on fear of child birth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
Gestational age 37 weeks and older
single pregnancy
Women 18 to 45 years old
Exclusion criteria:
Primiparous women with twin pregnancies and more
Illiterate women
Women with vision or hearing problems
Women with chronic diseases
History of mental illness
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of Tehran University of Medical Sciences
Street address
University of Nursing and Midwifery and Faculty of Rehabilitation - Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.156
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care
2
Description of health condition studied
Childbirth pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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.
2
Description
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
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: Routine delivery care for mothers and infants in the control group will be performed in accordance with the hospital routine