Determine the effect of guided visualization on anxiety and severity of labor pain in primipara women
Design
A randomized clinical trial with two groups (test and control) with parallel groups
Settings and conduct
This study was a randomized clinical trial and women were randomly divided into two groups of control and test. The sample size was 25 in each group and the location of the research was 22 Bahman hospital in Gonabad. For women in the experimental group, in addition to routine care at the onset of the active phase of labor (dilatation 3-4), the guided visualization, for 18 minutes through Headphones were broadcast, which included visual or beautiful scenery, only routine care was provided in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age range is 18-35years
first Pregnancy
Women before active phase of labor (dilatation less than 3-4 cm)
Gestational age 37-42weeks
Single throat embryo
Embryonic Cephalic Condition
Conscious Consent to Participate in the Study
No-entrance criteria: Pregnancy
Infection with polyhydraminosis and oligohydroaminosis known by ultrasound
Known for mental illness
Known for chronic diseases
Intervention groups
For women in the test group, in addition to routine care at the onset of the active phase of labor (dilatation 4-3), the guided visualization was broadcast for 18 minutes via headphones, which included the visualization of beautiful or pleasant scenery, in the control group only care Routine.
Main outcome variables
Anxiety and pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038821N2
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Iman Ghorbany Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0576
Email address
ghorbani.i@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2017-06-15, 1396/03/25
Trial completion date
2017-07-23, 1396/05/01
Scientific title
Effect of Guided Visualization on Anxiety and Severity of Labor Pain in Primipara Women
Public title
Effect of Guided Visualization on Anxiety and Severity of Labor Pain in Primipara Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 18-35 years
first Pregnancy
Women before active phase of labor (dilatation less than 3-4 cm)
Gestational age 37-42weeks
Single throat embryo
Embryonic Cephalic Condition
Conscious Consent to Participate in the Study
Exclusion criteria:
Pregnancy Blood Pressure
Infection with polyhydraminosis and oligohydroaminosis known by ultrasound
Known for mental illness
Known for chronic diseases
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:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the patients were selected by objective sampling method and applying the entry criteria and then divided into control and test groups by simple random method (throwing coins).
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
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Road Rim
City
Gonabad
Province
Razavi Khorasan
Postal code
96916-47161
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
GMU.AC.1393.126
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34.0
ICD-10 code description
Encounter for supervision of normal first pregnancy
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before the intervention, the active phase of labor was started (dilatation more than 3-4 cm) and after intervention the severity of labor pain was measured at dilatation of 6 - 7 and 9- 10.
Method of measurement
McGill Painter
2
Description
Anxiety
Timepoint
Before and after the intervention, the dilatation was measured at 6 - 7 and 9- 7.
Method of measurement
Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conducting a CD of guided imagery for 18 minutes through headphones that included beautiful or pleasant landscapes.
Category
Placebo
2
Description
Control group: Only routine care was performed for the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital, Gonabad
Full name of responsible person
Dr. Mohsen Saheb Maleki
Street address
Nasir Khosrow Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. shahla khosravan
Street address
Asian Roads, Gonabad University of Medical Sciences, Student Research Committee
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Fax
Email
imanghorbany135213@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Fax
Email
imanghorbany135213@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Fax
Email
imanghorbany135213@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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available