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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General information
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2025-02-07, 1403/11/19
2025-02-07 00:00:00
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2025-04-09, 1404/01/20
2025-04-09 00:00:00
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2025-04-09, 1404/01/20
2025-04-09 00:00:00
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Write the actual sampling start and end dates.
Write the actual sampling start and end dates.
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نوشتن تاریخ شروع وخاتمه نمونه گیری واقعی
نوشتن تاریخ شروع وخاتمه نمونه گیری واقعی
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leila Reisy
Full name of responsible person - Persian: لیلا رییسی
Street address - English: Jhanbazan Square, the end of University Street, above University Square - Ardabil Medical Sciences
Street address - Persian: میدان جانبازان،انتهای خیابان دانشگاه،بالاتر از میدان دانشگاه- دانشکده پزشکی
City - English: Ardabil
City - Persian: اردبیل
Province: Ardabil
Country: Iran (Islamic Republic of)
Postal code: 5618953141
Phone: +98 45 3353 4679
Fax:
Email: leilareisy@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fahad Pourfarzi
Full name of responsible person - Persian: فزهاد پور فرضی
Street address - English: Jhanbazan Square, the end of University Street, above University Square - Ardabil Medical Sciences
Street address - Persian: میدان جانبازان،انتهای خیابان دانشگاه،بالاتر از میدان دانشگاه- دانشکاه علوم پزشکی
City - English: Ardabil
City - Persian: اردبیل
Province: Ardabil
Country: Iran (Islamic Republic of)
Postal code: کدپستی: 5618953141
Phone: +98 45 3353 4757
Fax:
Email: F.pourfarzi@arums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Leila ReisyFahad Pourfarzi Full name of responsible person - Persian: لیلا رییسیفزهاد پور فرضی Street address - English: Jhanbazan Square, the end of University Street, above University Square - Ardabil Medical Sciences Street address - Persian: میدان جانبازان،انتهای خیابان دانشگاه،بالاتر از میدان دانشگاه- دانشکدهدانشکاه علوم پزشکی City - English: Ardabil City - Persian: اردبیل Province: Ardabil Country: Iran (Islamic Republic of) Postal code: کدپستی: 5618953141 Phone: +98 45 3353 46794757 Fax: Email: leilareisyF.pourfarzi@gmail.comarums.ac.ir Web page address:
Protocol summary
Study aim
The effect of using virtual reality on the fear and pain of labor in primiparous women referred to Alavi Medical Teaching Hospital in Ardabil.
Design
A clinical trial with 42 primiparous women were randomly assigned to intervention and control groups.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Fear of childbirth; pain of childbirth; virtual reality
General information
Reason for update
Write the actual sampling start and end dates.
Acronym
IRCT registration information
IRCT registration number:IRCT20240917063073N1
Registration date:2025-02-05, 1403/11/17
Registration timing:prospective
Last update:2025-05-21, 1404/02/31
Update count:2
Registration date
2025-02-05, 1403/11/17
Registrant information
Name
Mansoureh Delfekar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 1529
Email address
delfekarm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-11, 1403/07/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
2025-02-07, 1403/11/19
Actual recruitment end date
2025-04-09, 1404/01/20
Trial completion date
2025-04-09, 1404/01/20
Scientific title
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
Public title
The use of virtual reality on the fear and pain of labor
Purpose
Supportive
Inclusion/Exclusion criteria
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
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:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee of Ardabil University of Medical Sciences
Street address
At the end of University Street, the administrative complex of the University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.ARUMS.REC.1402.099
Health conditions studied
1
Description of health condition studied
Fear of child birth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care
2
Description of health condition studied
Labor pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
The variable of fear of childbirth is the fear score in the pre-test and post-test in the Harman questionnaire
Timepoint
The fear of childbirth questionnaire will be evaluated first at 4.5 cm dilation and then at 7.8 cm dilation.
Method of measurement
Harman fear of childbirth questionnaire
2
Description
Labor pain
Timepoint
At 4.5 cm dilation and then at 7.8 cm dilation
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: Routine delivery care for mothers and babies in the control group will be performed according to the hospital routine
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Mansoure Delfekar
Street address
Ayatollah Moghaddis Ardabili St. - Shahid Maadi St. - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
delfekarm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Fahad Pourfarzi
Street address
Jhanbazan Square, the end of University Street, above University Square - Ardabil Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
کدپستی: 5618953141
Phone
+98 45 3353 4757
Email
F.pourfarzi@arums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Leila Reisy
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahada Highway, between Hafez and Saadi Bridge, Ardabil Nursing and Midwifery College
City
Ardabil
Province
Ardabil
Postal code
5615751147
Phone
+98 45 3372 6085
Email
Leilareisy@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mansoure Delfekar
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Shahada highway, between Hafez and Saadi bridge, nursing and midwifery faculty
City
Ardabil
Province
Ardabil
Postal code
5615751147
Phone
+98 45 3372 6085
Email
delfekarm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mansoure Delfekar
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Shahada highway, between Hafez and Saadi bridge, nursing and midwifery faculty
City
Ardabil
Province
Ardabil
Postal code
5615751147
Phone
+98 45 3372 6085
Email
delfekarm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available