Protocol summary
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Study aim
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The effect of using virtual reality on the fear and pain of labor in primiparous women referred to Alavi Medical Teaching Hospital in Ardabil.
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Design
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A clinical trial with 42 primiparous women were randomly assigned to intervention and control groups.
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Settings and conduct
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A trial on 42 primiparous women referred to Alavi hospital in Ardabil city, they are randomly assigned to two intervention and control groups. First, both groups answer Harman's fear of childbirth questionnaire. Then, VR glasses in the intervention group dilate 4-5 cm and load. He watches his favorite virtual reality movie for 20 minutes in 7-8 cm dilation
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Participants/Inclusion and exclusion criteria
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Conditions for inclusion in the study: primiparous women with gestational age of 38-41 weeks without chronic diseases
Conditions of non-entry into the study, gestational age less than 37 weeks, blind
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Intervention groups
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Using virtual reality glasses on primiparous women in the intervention group for 20 minutes once in 4-5 cm dilation and once in 7-8 cm dilation.
In the control group without virtual reality glasses, they will receive normal care
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Main outcome variables
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Fear of childbirth; pain of childbirth; virtual reality
General information
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Reason for update
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Write the actual sampling start and end dates.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240917063073N1
Registration date:
2025-02-05, 1403/11/17
Registration timing:
prospective
Last update:
2025-05-29, 1404/03/08
Update count:
2
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Registration date
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2025-02-05, 1403/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-10-11, 1403/07/20
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Expected recruitment end date
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2024-12-10, 1403/09/20
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Actual recruitment start date
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2025-02-07, 1403/11/19
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Actual recruitment end date
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2025-04-09, 1404/01/20
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Trial completion date
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2025-04-09, 1404/01/20
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Scientific title
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The effect of using virtual reality on the fear and pain of labor in primiparous women referred to Alavi educational and therapeutic hospital in Ardabil city
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Public title
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The use of virtual reality on the fear and pain of labor
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Primiparous women
Gestation age 38 to 41 weeks
No underlying disease
singleton pregnancy
Exclusion criteria:
Chronic diseases
Gestational age less than 37 weeks
Mental illnesses
blind people
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
42
Actual sample size reached:
42
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-15, 1402/04/24
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Ethics committee reference number
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IR.ARUMS.REC.1402.099
Health conditions studied
1
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Description of health condition studied
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Fear of child birth
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ICD-10 code
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F40.232
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ICD-10 code description
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Fear of other medical care
2
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Description of health condition studied
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Labor pain
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ICD-10 code
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G89.18
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ICD-10 code description
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Other acute postprocedural pain
Primary outcomes
1
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Description
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The variable of fear of childbirth is the fear score in the pre-test and post-test in the Harman questionnaire
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Timepoint
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The fear of childbirth questionnaire will be evaluated first at 4.5 cm dilation and then at 7.8 cm dilation.
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Method of measurement
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Harman fear of childbirth questionnaire
2
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Description
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Labor pain
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Timepoint
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At 4.5 cm dilation and then at 7.8 cm dilation
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Method of measurement
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visual analog scale
Intervention groups
1
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Description
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The fear questionnaire and pain intensity measurement scale (research tool) will be completed at the beginning of the active phase of labor (4-5 cm dilatation) for both groups, then the virtual reality headset will be provided to the participants after entering the active phase of labor (headset Virtual reality is a 3D glasses that the mother is asked to wear. The glasses contain relaxing images, including new immersive virtual environments such as orange sunsets, green meadows, blue oceans, red savannas. The mother chooses one of the images and watches for 20 minutes. The minimum time to use the headset will be 20 minutes until the end of the first stage of labor. The pain and fear of childbirth in the second stage will be evaluated at 4-5 cm dilatation and 7-8 cm dilatation.
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Category
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Prevention
2
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Description
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Control group: Routine delivery care for mothers and babies in the control group will be performed according to the hospital routine
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ardabil University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable