The purpose of this clinical trial is comparison between effectiveness of Teach Back method and accompanying person on anxiety level and vital signs in women undergo cesarean section. Inclusion criteria : age 20 to 30 years old, not treated with anxiolytic or sedative drugs during hospitalization, have consent to participate in the study and have moderate(41-60) or severe(61-80) anxiety according to the STAI and candidate for the first cesarean section. Exclusion criteria : psychological disorders, hearing loss, and unwillingness to continue participation in the study. Population of the study included all primiparous women undergoing cesarean section and The sample size included 90 primiparous women undergoing cesarean section. In this study, patients according to inclusion criteria were selected and randomly divided in three groups ( 2 groups of cases and 1 control group): group 1; were educated with teach back method in the night before their surgery, group 2; accompanying person were present in the ward from the night before their surgery until 15 minute to the start of surgery and group 3; was control group that received routine care. Anxiety levels and vital signs were evaluated before and after intervention by using Spiel Berger State-Trait Anxiety (STAI) Inventory. The effect of Teach Back method and Accompanying person on anxiety level and vital sign situation will be measured.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014041417270N1
Registration date:2014-10-29, 1393/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-29, 1393/08/07
Registrant information
Name
Nasim Hatefi Moadab
Name of organization / entity
Ahvaz Jundishapur Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 728 2886
Email address
hatefi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-07-05, 1393/04/14
Expected recruitment end date
2014-09-05, 1393/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Teach Back educational method and accompanying person on anxiety and vital signs changes in woman candidate for cesarean section
Public title
The comparison of Teach Back educational method and accompanying person on anxiety and vital signs changes in woman candidate for cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 30 years old, not treated with anxiolytic or sedative drugs during hospitalization, have consent to participate in the study have moderate(41-60) or severe(61-80) anxiety according to the STAI and candidate for the first cesarean section. Exclusion criteria: psychological disorders, hearing loss, and unwillingness to continue participation in the study.
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ahvaz Judishapur University of Medical Sciences, Golestan highway, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2014-10-07, 1393/07/15
Ethics committee reference number
ajums.REC.1393.216
Health conditions studied
1
Description of health condition studied
surgical anxiety
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
anxiety before surgery
Timepoint
the night beore surgery and the day of the surgery
Method of measurement
Spiel Berger State-Trait Anxiety inventory
Secondary outcomes
1
Description
Systole Blood Pressure
Timepoint
Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention)
Method of measurement
mmHg- Electronic Manometer(Beurer made in Germany)
2
Description
Diastole Blood Pressure
Timepoint
Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention)
Method of measurement
mmHg- Electronic Manometer(Beurer made in Germany)
3
Description
Respiratory Rate
Timepoint
Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention)
Method of measurement
Number in minute by using analog clock and numeration
4
Description
Pulse Rate
Timepoint
Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention)
Method of measurement
Number in minute by using analog clock and numeration
5
Description
Temperature
Timepoint
Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention)
Method of measurement
Mercury thermometer made in iran
Intervention groups
1
Description
second intervention group is the Accompanying Person group.In this group, routine training provided by the ward nurse and their partner were allowed to present next to them from the night before the surgery until 15 minutes before starting their surgery in the operating room.
Category
Prevention
2
Description
First intervention group is the Teach Back group. In this group individuals were educated by using Teach Back method in this way that after determining training needs, educational program that is approved by the faculty, provided by researcher. In this method, researcher visits the patients at the night before their surgery and educates them face-to-face, in simple and understandable terms without use of special medical training terms in 45-30 minute. After completion of training, the patient were asked to say what they understand, in their own words. If the patient has not understood the content of sessions, educator would continue to explain until the patient would fully understand the contents. this educational program has a regular structure and Is flexible to suit the patient's needs that contains an overview of cesarean section include Reasons for Cesarean delivery, cesarean section maternal care, events are expected in the operating room and so on. To implement the method, face to face training will be used to raise the level of patient knowledge. One hour after training, the patient will be referred for evaluation of feedback and the patient's problems and questions will be answered. The Teach-Back score is set so that if the patient has 75% correct answers to the questions asked, it is considered an effective means of teaching and learning will continue otherwise.
Category
Prevention
3
Description
Control group is the third group whom no intervention applyed to them except routine educations.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital in Abadan
Full name of responsible person
Nasim Hatefi Moadab
Street address
Faculty of Nursing, Taleghani Hospital Educational Complex, Abadan, Iran
City
Abadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Bahram Ebdali
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
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 of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasim Hatefi Moadab
Position
Student of Medical Surgical Nursing in M.S
Other areas of specialty/work
Street address
Faculty of Nursing, Taleghani Hospital Educational Complex, Abadan, Iran
City
Abadan
Postal code
Phone
+98 83 3424 2764
Fax
Email
hatefi.n@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Group manager/Phd
Other areas of specialty/work
Street address
Faculty of Nursing, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
-
Fax
Email
elahi-n@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Abadan School of Medical Sciences
Full name of responsible person
Khadije Moradbeygi
Position
Member of Faculty In Abadan School of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing, Taleghani Hospital Educational Complex, Abadan, Iran
City
Abadan
Postal code
Phone
-
Fax
Email
khadijemoradbeygi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)