Comparing the effect of local cold, heat and intermittent heat-cold application on pain intensity after cesarean section
Design
A clinical trial with control group, parallel group, not blinded, with 80 patients.The randomization is performed according to randomized block design.
Settings and conduct
For performing the study, the research samples placed randomized in study groups. The randomization is performed according to randomized block design.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients after cesarean section; Communication ability
Exclusion criteria: Occurring crisis condition;, Alteration in patient status; First-born mothers
Intervention groups
The first group: application of local coldness
The second group: application of local heat
The third group: intermittent heat-cold application
The fourth group: routine care
Main outcome variables
Pain intensity after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005134N13
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Ali Fakhr-Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4192
Email address
Alimovi49@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-03-12, 1400/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of local cold, heat and intermittent heat-cold application on pain intensity after cesarean section
Public title
Comparing effect of local cold, heat and intermittent heat-cold application on pain intensity after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients after cesarean section
Communication ability
Age between 18 to 35 years
Exclusion criteria:
Occurring crisis condition
Alteration in patient status
First-born mothers
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Study samples are randomly assigned to study groups after selection. Study samples are allocated equally to the study groups by the permuted randomized block design with quadruple blocks. Random blocks are made using the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists
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 commitee of Semnan university of medical sciences
Street address
Basij Blvd; The central headquarters of the mobilization of the Boulevard, Semnan University of medical sciences, Vice President for research and technology
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.SEMUMS.REC.1399.036
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
The pain intensity after cesarean section
Timepoint
Before intervention and 20 minutes after intervention
Method of measurement
Visual analog scale of pain
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention and 20 minutes after intervention
Method of measurement
Sphygmomanometer
2
Description
Pulse rate
Timepoint
Before intervention and 20 minutes after intervention
Method of measurement
Pulse oximetry device
3
Description
Respiration rate
Timepoint
Before intervention and 20 minutes after intervention
Method of measurement
Counting in one minutes
4
Description
Body temperature
Timepoint
Before intervention and 20 minutes after intervention
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group 1: application of local cold gel pack with zero to -5 centigrade degree for 20 minutes on cesarean section dressing
Category
Other
2
Description
Intervention group 2: application of local heat gel pack with 38 to 40 centigrade degree for 20 minutes on cesarean section dressing
Category
Other
3
Description
Intervention group 3: intermittent heat-cold application as first, 10 minutes of local heat and then 10 minutes of local cold are applied to cesarean section dressing by the gel pack
Category
Other
4
Description
Intervention group 4: usual care according to ward routine
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al-Momenin hospital
Full name of responsible person
Dr. Seyed Mohammad Hosseini
Street address
Imam Hossein Sq., Shahid Mostafa Khomeini Blvd.
City
Semnan
Province
Semnan
Postal code
3473135197
Phone
+98 23 3346 0055
Email
amirhos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Parviz Kokhaei
Street address
The Central Headquarters of Semnan University of Medical Sciences, Vice Chancellor for Research and Technology, Basij Bvld
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
Info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, Kilometer 5, Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Email
Alimovi49@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, Kilometer 5, Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Email
Alimovi49@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, Kilometer 5, Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Email
Alimovi49@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
1. The study protocol 2. The results of the study
When the data will become available and for how long
After termination of the study
To whom data/document is available
1. Faculty members 2. The clinical nurses 3. The medical and nursing students
Under which criteria data/document could be used
Access to data or documentation is subject to the following conditions: 1- Use in Future Studies References 2- The future studies
From where data/document is obtainable
Please contact Ali Fakhr-Movahedi Email: alimovi@yahoo.com
What processes are involved for a request to access data/document
After emailing Ali Fakhr-Movahedi, email will be answered as soon as possible.