Objectives: Comparison of the effect of educational software and educational booklet on pain and anxiety during labor.
Design: Randomized Controlled Trial with three parallel arms.
Setting and conduct: This study will be carried out in health centers of Miandoab city. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 51 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: 153 pregnant women aged 18 to 35 years with gestational age of 30 to 36 weeks.
Interventions: After completing the baseline questionnaires, one intervention group will receive educational software and the other intervention group will receive educational booklet. The control group will receive routine care. The participants will be taught how to use educational tools by the researcher. Participants will study software and booklet until they have mastered. Participants will be followed up in the hospital until the end of delivery.
Main outcome measures include anxiety that will be evaluated before and after the admission in hospital and also severity of pain that will be evaluated during labor. Secondary outcomes include knowledge rate and labor self-efficacy that will evaluated before and after the admission in hospital and also duration of the active phase of labor and second stage of delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072110324N24
Registration date:2015-08-22, 1394/05/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of educational software and educational booklet on pain and anxiety during labor: a randomised controlled trial
Public title
Comparison of the effect of educational software and educational booklet on pain and anxiety during labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 to 35 years; 30 to 36 weeks of pregnancy; Primigravida; Singleton pregnancy; Access to the computer; Knowledge of how to use a computer or access to a person who assist her in the use of computer; Having no visual problem; Having secondary education or more.
Exclusion Criteria: Suffering of any pregnancy complications (such as placental abruption, fetal death, premature rupture of membranes, preterm labor, pregnancy induced hypertension and gestational diabetes); High-risk pregnancy (such as the presence of known underlying disease including heart disease, lung disease, hypertension, diabetes, history of infertility, cervical cerclage in current pregnancy and abortion history); Existence of known contraindication for vaginal delivery (abnormal presentation of fetus, placenta and umbilical cord problems, cephalopelvic disproportion, medical-surgical problem, fetal distress, etc.); Participation in preparation classes for childbirth; Woman willingness to perform cesarean delivery.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
153
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City
Tabriz
Postal code
Approval date
2015-08-12, 1394/05/21
Ethics committee reference number
TBZMED.REC.1394.414
Health conditions studied
1
Description of health condition studied
Pain, Anxiety
ICD-10 code
R10, F41.1
ICD-10 code description
Abdominal and pelvic pain, Generalized anxiety disorder
Primary outcomes
1
Description
Pain
Timepoint
Active phase of labor per hour
Method of measurement
Visual Analogue Scale
2
Description
Anxiety
Timepoint
Before intervention and after the admission in hospital for delivery
Method of measurement
Spielberger's Questionnaire
Secondary outcomes
1
Description
Labor self-efficacy
Timepoint
Before intervention and after the admission in hospital for delivery
Method of measurement
Labor self-efficacy questionnaire
2
Description
Knowledge
Timepoint
Before intervention and after the admission in hospital for delivery
Method of measurement
Knowledge questionnaire
3
Description
Duration of the active phase of labor
Timepoint
From dilatation of 4 cm until full dilatation
Method of measurement
Partograph form in terms of minute
4
Description
Second delivery phase
Timepoint
From full dilation until the newborn expulsion
Method of measurement
Partograph form in terms of minute
Intervention groups
1
Description
First intervention group will receive educational software.
Category
Prevention
2
Description
The second intervention group will receive educational booklet.
Category
Prevention
3
Description
The control group will receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Miandoab city
Full name of responsible person
Parastoo Abbasi
Street address
Miandoab city, West Azerbaijan province
City
Miandoab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Parastoo Abbasi
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1331 2679
Fax
Email
par.a1985@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
00
Fax
+98 41 3475 2839
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)