determinating the effect of Auriculotherapy and Reflexology on the pain after elective cesarean section
Design
Clinical practice with control group, Double blind, Randomized
Settings and conduct
The place of study is the women,s ward of Ali ibn Abitaleb Hospital and Niknaf clinic in Rafsanjan
Participants/Inclusion and exclusion criteria
Inclusion criteria: single pregnancy; low-risk pregnancy; not having special disease history; lack of starting labor pain ;having a transverse incision cesarean section surgery;belonging to the first class of anesthesia risk ;
Exclusion criteria:Discomfort in ear or pain while massaging or putting pressure on feet; Complications during and after cesarean section
Intervention groups
samples in all of the three groups are studied from 6 hours after the cesarean section to 24 hours later. In the reflexology group, intervention takes place for 20 minutes in both 6 hours and 30 hours after the cesarean section. The pain is measured before and 20 minutes after each intervention. In auriclotherapy. group , the auricular seed are attached for 24 hours. the pain is measured just before and 20 minutes after attaching the earrings; the same is done for dispatching them.in control group, the researcher is present
at the mother's bedside for 20 minutes doing nothing twice :6 hours and 30 hours after the cesarean section. the pain is measured by VAS just before and 20 minutes after the researcher's physical presence.
Main outcome variables
Caesarean section pain ; Drug consumption amount
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N15
Registration date:2019-07-30, 1398/05/08
Registration timing:retrospective
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of reflexology and auriculotherapy on the pain after cesarean section
Public title
Comparing the effects of reflexology and auriculotherapy on the pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the Age of 18-35,,
Elective surgery
ear's health for reflexology and feet's health for auriculotherapy
Exclusion criteria:
Foreigners
Unpleasant sensation of the feet massage
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
By Simple randomization method and through lottery , it is determined which intervention should be used in each session
Blinding (investigator's opinion)
Double blinded
Blinding description
both the participants in the study and the person evaluating the pain are blind to the intervention
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
Ir.rums.rec.1397.085
Health conditions studied
1
Description of health condition studied
pain of cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Six hours and thirty hours after cesarean section, just before and after intervention
Method of measurement
Based on numerical scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Reflexology is done for 20 minutes twice ; six hours and thirty hours after cesarean section. the pain scale is measured by VAS immediately befor and after Reflexology
Category
Treatment - Other
2
Description
Intenvention group 2: Earrings are attached to the ears 6 hours after cesarean section for 24 hours. just befor the attachment and 20 minutes after that , the pain is measured by VAS. and also , befor and 20 minutes after dispatching the earrings , the pain is measured by VAS.
Category
Treatment - Other
3
Description
Intervention group3:In conrol group, researcher is present at the mother,s bed doing nothing for 20 minutes, twice: 6 hours and 30 hours after cesarean section.just befor and 20 minutes after, the researcher,s physical presence , the pain is measured by VAS.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital And NikNafs Maternity Hospital
Full name of responsible person
Dr.Majid Kazemi
Street address
Ali Ibn Abi Talib Square, Imam Ali Street And Shahada Street
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3422 8324
Email
dr.kazemi.n@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3422 8324
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Emam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 7663
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Emam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 7663
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
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