Assessment the effect of face to face education followed by pamphlet on preoperative anxiety level of pregnant women undergoing elective cesarean section in Shariati hospital.
The main purpose: Assessment the effect of face to face education followed by pamphlet about the process of operation and anesthesia on preoperative anxiety level of pregnant women undergoing elective cesarean section.
Main inclusion criteria: No having experience of any surgery; The case of gravid 1 (first cesarean section); ASA class I or II
Main exclusion criteria: Level of education below the high school.
The design of this study: randomized, single -blind, distribution of STAI(State-Trait Anxiety Inventory) questionnaire and VAS(visual analog scale) scoring tool to both control and intervention groups in a day before cesarean section then face to face education followed by pamphlet to the intervention group and giving STAI questionnaire and VAS scoring tool only to the intervention group after education on the same day.
Population of this study: Pregnant women undergoing cesarean section in Dr.Ali Shariati Hospital of Tehran.
Sample size: 25 cases in the control group and 25 cases in the intervention group.
The intervention in this study: Face to face education followed by pamphlet.
Time of the intervention: 2015.
Sample size: 25 cases in the control group and 25 cases in the intervention group.
Primary outcomes: Anxiety, Type of Anesthesia technique
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060622576N1
Registration date:2015-08-09, 1394/05/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-09, 1394/05/18
Registrant information
Name
Alireza Saliminia
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 6347
Email address
a-saliminia@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-09-01, 1394/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of face to face education followed by pamphlet on preoperative anxiety level of pregnant women undergoing elective cesarean section in Shariati hospital.
Public title
The effect of education on anxiety level before cesarean section
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria in both control and intervention groups:
No having experience of any surgery;The case of gravid 1 (first cesarean section);
ASA class I or II
Exclusion criteria in both control and intervention group:
Level of education below the high school
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poorsina Street, Keshavarz Avenue, Tehran
City
Tehran
Postal code
1411713135
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.TUMS.REC.1394.498
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
before and after the intervention on the same day of intervention in a day before operation
Method of measurement
STAI questionnare and VAS
2
Description
Type of Anaesthesia technique
Timepoint
After the intervention on a day after cesarean section
Method of measurement
patient file
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
after cesarean section
Method of measurement
asking the patients
Intervention groups
1
Description
One face to face training session followed by Pamphlet in a day before cesarean section to the intervention group
Category
Other
2
Description
without any intervention in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr.Alireza Saliminia
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahin Akhoondzadeh
Street address
Tehran University of Medical Sciences, Poorsina Street, Keshavarz Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Shariati Hospital
Full name of responsible person
Dr.Alireza Saliminia
Position
Assistant Professor of Anaesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
Email
Alirezasaliminia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Dr.Alireza Saliminia
Position
Assistant Professor of Anaesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
+98 88633039
Email
Alirezasaliminia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Dr.Alireza Saliminia
Position
Assistant Professor of Anaesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
Email
Alirezasaliminia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)