Pain management during labor through a non-pharmacological and low-cost method called virtual reality in order to encourage women to natural child birth
Design
A clinical trial with a control and an intervention groups, randomized by permutation block method
Settings and conduct
This clinical trial investigates the effect of virtual reality on labor pain management in the first and second stages of childbirth; it will be accomplished in Imam Khomeini Hospital, Tehran, Iran on 24 women in the control group and 24 women in the intervention group.
Participants/Inclusion and exclusion criteria
Eligible patients are any woman giving birth for the first time at after 38 weeks, who does not have a desire to a non-pharmacologic alternative for pain control, who has a low risk pregnancy without obstetric complications. Exclusion criteria include the need to use other methods of analgesia (epidural analgesia or other opioids) and age<18 and age>45.
Intervention groups
For mothers presenting in labor with standard care, the patient will experience their contractions while using Virtual Reality. Control group: For mothers presenting in labor with standard care the patient will experience their contractions. Then, both groups will be asked to answer pain and satisfaction questionnaires.
Main outcome variables
Pain and Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042099N1
Registration date:2019-06-25, 1398/04/04
Registration timing:prospective
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Narges Momenyan
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 0000
Email address
n.momenyan@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of virtual reality (VR) on pain management during labor
Public title
Investigating the effect of virtual reality (VR) on pain management during labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The moder's nationality should be Iran and must be able to read and write.
The delivery type should be vaginal delivery.
Any woman giving birth for the first time at after 38 weeks
The mother does not have drug addiction.
The mother does not suffer from a known chronic disease such as diabetes, hypertension, heart disease and infectious diseases.
The mother does not have a bad memory of the simulated environment
The mother does not have a desire to a non-pharmacologic alternative for pain control
Low risk pregnancy without obstetric complications
Exclusion criteria:
Need to use other methods of analgesia (epidural analgesia or other opioids)
Younger than 18 or older than 45 years of age
Presence of fetal or placental anomaly
Any face/head/neck injuries that interfere with the use of Virtual Reality headset
Seizure history
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:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by permutation block method with the size of block 2, so that the number of samples in the two groups would be equal. For this purpose, dual blocks will first be created from codes A and B. Then, according to the random number table, a sequence of these dual blocks will be formed. According to the patient's number, the code A or B would be assigned to the patient according to the sequence, so that patients with code A will be in the intervention group and the patients with code B will be in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
No. 7, Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MODARES.REC.1397.170
Health conditions studied
1
Description of health condition studied
Pain management during labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
One time in the active phase of first stage of labor for the duration of one minute after 10 minutes of contractions, One time in the second stage of labor for the duration of one minute after 10 minutes of contractions
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Anxiety
Timepoint
One time in the active phase of first stage of labor for the duration of one minute after 10 minutes of contractions, One time in the second stage of labor for the duration of one minute after 10 minutes of contractions
Method of measurement
questionnaire
Secondary outcomes
1
Description
Nausea
Timepoint
One time in the active phase of first stage of labor for the duration of one minute after 10 minutes of contractions, One time in the second stage of labor for the duration of one minute after 10 minutes of contractions
Method of measurement
questionnaire
Intervention groups
1
Description
The interventions will be done in the active phase of first stage of labor for 3 contractions almost 10 minutes and in the second stage of labor for 2 contractions almost 10 minutes. The virtual reality headset will be fitted on the mother' head which through it, the mother sees the natural environment and hears the nature's sounds.
Category
Prevention
2
Description
Control group: mothers in in the active phase of first stage of labor for 3 contractions almost 10 minutes and in the second stage of labor for 2 contractions almost 10 minutes will be observed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Sedigheh Hantoushzadeh
Street address
Chamran East Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mansoreh Movahedin
Street address
Tarbiat Modares University, No. 7, Jalal Al Ahmad street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
n.momenyan@modares.ac.ir
Web page address
http://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Ali Asghar Safaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Tarbiat Modares University, No. 7, Jala Al Ahmad Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
aa.safaei@modares.ac.ir
Web page address
http://www.modares.ac.ir/~aa.safaei
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Hantoushzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Khomeini Hospital, Chamran East Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
hantoushzadeh@tums.ac.ir
Web page address
https://www.tums.ac.ir/faculties/hantoushzadeh
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Narges Momenyan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
No. 7, Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Fax
Email
n.momenyan@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A paper entitled "Investigating the effect of Virtual Reality on pain management during labor"
When the data will become available and for how long
Start the access period 3 months after printing the results