A convenient way to reduce the anxiety caused by elective cesarean section
Design
This community-oriented and pragmatic control group was conducted with parallel, randomized, and blinded groups. Each group included 45 people.
Settings and conduct
Interventions will be done once per hour and in total four times until the time of surgery for pregnant women. For the control group, a neutral item (fruit and vegetable properties) provided and presented to them. The access to the patients in person will be in the ward of obstetrics and gynecology in Ahwaz Imam Khomeini Hospital. After collecting data based on the Hamilton anxiety scale in both control and intervention groups, the results will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All pregnant women who are referred for elective cesarean section
Exclusion criteria:
History of continuous use of benzodiazepines, antipsychotics, psychotropic drugs and opiates.
Intervention groups
After assessing the concerns, the amount of patient information and beliefs about performing cesarean section will take place in three areas of cognitive and behavioral information intervention.
The duration of the intervention for the intervention group will be performed in the control group for progressive muscle relaxation for 20-25 minutes.
Main outcome variables
Mental anxiety; physical anxiety; radial pulse; number of respiration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150121020739N5
Registration date:2018-03-24, 1397/01/04
Registration timing:retrospective
Last update:2018-03-24, 1397/01/04
Update count:0
Registration date
2018-03-24, 1397/01/04
Registrant information
Name
Forouzan Behroozina
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
behrouzian-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-06-22, 1396/04/01
Trial completion date
empty
Scientific title
Study of the Effects of relaxation therapy in reducing anxiety in patients referred for elective cesarean
Public title
Effects of relaxation therapy in reducing anxiety in patients referred for elective cesarean
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women who are referred for elective cesarean section
Have at least written literacy
Examination and ultrasonographic examination of the pelvis and normal tests include prolactin in the range of 4-23 ng / ml, TSH in the range of 0.3-5 U / ml and FSH in the range 4.7-21.5 mlU / ml
Exclusion criteria:
History of continuous use of benzodiazepines, antipsychotics, psychotropic drugs and opiates.
History of anxiety disorders and attacks, or any history of previous psychiatric illness
The presence of dystocia and hard labor in previous pregnancies
Early baby birth in previous pregnancies
any maternal and perinatal risk of cesarean delivery as non-active.
Smoking or history of drug use and anti-anxiety
History of congestive heart disease-asthma-COPD-type 1 and type 2 diabetes, history of hypertension
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
randomization was done by random number table
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Azadegan Ave, Imam khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.AJUMS.REC.1396.735
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F40,F41,F4
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Comparison of anxiety level in intervention and control group
Timepoint
before and after cesarean section
Method of measurement
Hamilton Anxiety Inventory
2
Description
Determining the Relationship between Clinical Factors and the Impact of Mental Readiness
Timepoint
before and after cesarean section
Method of measurement
Hamilton Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After assessing the concerns, the patient's information and beliefs about cesarean delivery in three areas of cognitive and behavioral information will be subjected to the following intervention: 1. Information control: At this stage, the patient's incorrect information is corrected and additional information on how to perform it. Caesarean section, time, duration, and general conditions for conducting cesarean section will be given to the patient. 2. Cognitive control: Due to the cognitive distortions in the patient, cognitive control will be provided to the patient (for example, the patient's attention to the benefits of the operation And its positive points instead of emphasizing the unpleasant and negative aspects of it) 3- Behavioral control: from the face Behavioral control items including specific respiratory exercises, relaxation, distraction technique, etc. will be provided to the patient to use these methods in case of anxiety.
Category
Behavior
2
Description
Control group: The duration of the intervention is for the case group. In the case group, progressive muscle relaxation will be performed for 25-20 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Horasa Tabibi
Street address
َAzadegan Ave. Imam khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Horasa_tabibi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Horasa Tabibi
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Horasa_tabibi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Horasa Tabibi
Position
professional doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Horasa_tabibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Horasa Tabibi
Position
professional doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
horasa_tabibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Horasa Tabibi
Position
professional doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Horasa_tabibi@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available