Evaluation the effect of electric blanket on post-cesarean shivering undergone spinal anesthesia in Bushehr's Persian Gulf hospital.
Design
Clinical trial with control group, with parallel groups design of 112 patients, randomized controlled block, single blind
Settings and conduct
When entering the recovery room of Persian Gulf Hospital in Bushehr, an electric blanket will be placed for the case group and a turned-off electric blanket will be used for the control group and shivering will be recorded before the intervention, 5 minutes and 10 minutes after the intervention.The study was conducted in a blinded manner with the control group using a turned-off electric blanket without patients awareness.
Participants/Inclusion and exclusion criteria
Including criteria:
Termination of pregnancy at term (37-42 weeks), spinal anesthesia surgery
excluding criteria:
vascular diseases, addiction, amniotic membrane rupture, illnesses with symptoms of chills or seizures (Parkinson's disease, epilepsy, etc.), endocrine disorders
Intervention groups
For the case group, an electric blanket is placed when the patient enters the recovery room. And for control group a symbolic electric blanket is used.
Control group: The electric blanket will be turned off for this group.
Main outcome variables
Shivering rate (before intervention, 5 minute and 10 minutes after intervention through observation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190729044364N1
Registration date:2019-11-01, 1398/08/10
Registration timing:registered_while_recruiting
Last update:2019-11-01, 1398/08/10
Update count:0
Registration date
2019-11-01, 1398/08/10
Registrant information
Name
parviz azodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0084
Email address
azodi.parviz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of electric blanket on post-cesarean shivering undergone spinal anesthesia in Bushehr's Persian Gulf hospital.
Public title
The effect of electric blanket on post-cesarean shivering undergone spinal anesthesia in Bushehr's Persian Gulf hospital.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Termination at term pregnancy (37-42 weeks)
Surgery by spinal anesthesia
Exclusion criteria:
No vascular disease
No addiction
No rupture of the amniotic membrane
No illnesses that are symptoms of shivering or seizures (Parkinson's disease, epilepsy, ....)
No endocrine disruptions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Random block allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
The control group use a turned-off electric blanket which the patient's perception is the opposite.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences- Pardis site, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
7565184345
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.BPUMS.REC.1398.027
Health conditions studied
1
Description of health condition studied
Postoperative shivering of cesarean patients undergoing spinal anesthesia
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature
Primary outcomes
1
Description
Shivering rate
Timepoint
Before, 5 minutes after and 10 minutes after intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Case group: A switched-on electric blanket will be placed for this group
Category
Treatment - Devices
2
Description
Control group: The electric blanket will be turned off for this group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf hospital
Full name of responsible person
Parviz Azodi
Street address
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2247
Fax
Email
parviz.azodi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza khamisipour
Street address
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
ghr.khamisi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Parviz Azodi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2247
Fax
Email
parviz.azodi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Parviz Azodi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Pardis Site of Bushehr University of Medical Sciences, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2247
Fax
Email
parviz.azodi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Parviz Azodi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Pardis Site of BushehrUniversity of Medical Sciences, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Fax
Email
parviz.azodi@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
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
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