METHODS: This study is a randomized clinical trial with a control group. The aim of this study is to determine the effectiveness of virtual reality on episiotomy pain in primiparous women .The population of the study is primiparous women with eligibility criteria. The sample size is estimated to be 30 women who will be randomly allocated to the two treatment groups of 15 people (users of audiovisual glasses and routine injections with lidocaine) and a control group (routine injection of lidocaine). Pain will be measured with the Numeric Pain Rating Scale (0-10). During the four stages which are before repair, prescription of anesthesia (during repair of skin and Hymen), immediately and the first hour after of episiotomy repair. Inclusion criteria: Iranian people; primiparous; being in the active phase of labor (dilation 4-5 cm); pregnancy with single fetus; Cephalic presentation; Episiotomy incision; Apgar score of 7-10; no birth anomaly; no history of mental illness; mother addiction; no history of motion sickness; headache.
It is excluded because of: impaired vision or hearing; prescription pain medication before or during episiotomy repair (except single dose of Lidocaine); any obstetric complications required emergency Aid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811063185N1
Registration date:2013-12-01, 1392/09/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-01, 1392/09/10
Registrant information
Name
Samira Ebrahimzadeh Zagami
Name of organization / entity
School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
ebrahimzadehzs@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Research of Mashhad University of Medical Science
Deneshghah Street, Mashhad, Khorasan Razavi, Iran.
Expected recruitment start date
2012-05-22, 1391/03/02
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Virtual Reality On Pain In Primiparity Women During Episiotomy Repair
Public title
The Effect Of Virtual Reality On Pain During Suture Repair After Delivery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian people; primiparous; being in the active phase of labor (dilation 4-5cm); pregnancy with single fetus; Cephalic presentation; Episiotomy incision; Apgar score of 7-10; no birth anomaly; no history of mental illness; mother addiction; no history of motion sickness; headache.
Exclusion criteria: Impaired vision or hearing; receiving pain medication before or during episiotomy repair (except single dose of Lidocaine); any obstetric complications required emergency Aid.
Age
From 18 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
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
Mashhad University of Medical Sciences
Street address
Daneshghah street, Mashhad
City
Mashhad
Postal code
Approval date
2011-11-26, 1390/09/05
Ethics committee reference number
89600
Health conditions studied
1
Description of health condition studied
Episiotomy pain
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Pain
Timepoint
During the four stages:1. before repair and prescription of anesthesia 2. during repair of skin and Hymen 3. immediately after repair 4.the first hour after repair.
Method of measurement
Numeric Pain Rating Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after episiotomy
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention group: Use of audiovisual glasses + Standard prescription of anesthesia
Control group : Standard prescription of anesthesia
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Farial Pabarja
Street address
Hasheminejhad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Research of Mashhad University of Medical Science
Full name of responsible person
Dr. Mohamad Ramezani
Street address
Daneshghah Street,Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Research of Mashhad University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing & Midwifery
Full name of responsible person
Nahid Jahani Shoorab
Position
Faculty member
Other areas of specialty/work
Street address
Ebne-Sina Street-Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
jahanishn@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing & Midwifery
Full name of responsible person
Nahid Jahani Shoorab
Position
Faculty member
Other areas of specialty/work
Street address
Ebne-Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
jahanishn@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing & Midwifery
Full name of responsible person
Nahid Jahani Shoorab
Position
Faculty member
Other areas of specialty/work
Street address
Ebne-Sina street
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
jahanishn@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)