Objectives: The effectiveness of acupressure on pain relief after cesarean.
Design: double blinded, randomized trials.
Setting and conduct: In this study, after obtaining informed consent from patients will be allocated to intervention and control group according to randomized method, with block size of 4.
Inclusion criteria: Having at least primary education level; full consciousness in women after cesarean section; no previous experience using acupressure for any reason, no injuries; without bruising, tenderness or itching on LI4 location; all repeated cesarean and cesarean patients, including those who are first cesarean. Exclusion criteria: Patients with pre-eclampsia in the postoperative period which magnesium sulfate have been used for them.
Interventions: In the intervention group, acupressure will be done for 20 minutes in L14 point. During this time all specified points lies under pressure for 10 seconds and rest for 2 seconds respectively. Then confirm the point when the patient is feeling of warmth and swelling at that point. The pressure is about 3-5 kg which the amount of pressure was performed by the person who has passed the initial periods of acupuncture.
Touch without pressure will be used in the control group at these points. Interventions for all samples were done by a single researcher to prevent of any bias as much as possible. Degree of pain is measured by using the ruler of the (VAS) by a trained person who had no information in the type of intervention (touch or pressure) of both groups (control and test groups). All patients in both groups received routine care and the amount of narcotic and analgesic drugs were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080722407N3
Registration date:2015-12-19, 1394/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-19, 1394/09/28
Registrant information
Name
Somayeh Ramezani
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7213
Email address
s.ramezani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acupressure on pain relief after cesarean.
Public title
Acupressure on pain after cesarean
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having at least primary education level; full consciousness in women after cesarean section; no previous experience using acupressure for any reason; no injuries; without bruising, tenderness or itching on LI4 location; all repeated cesarean and cesarean patients, including those who are first cesarean. Exclusion criteria: Patients with pre-eclampsia in the postoperative period which magnesium sulfate have been used for them.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square,Shahroud.
City
Shahroud
Postal code
3614773955
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
IR.shmu.rec.1394.31
Health conditions studied
1
Description of health condition studied
Pain after caesarean
ICD-10 code
O80,O84
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Pain after cesarean
Timepoint
Immediately after the intervention, and 30 minutes and one hour and two hours after the intervention.
Method of measurement
Rule of VAS
Secondary outcomes
1
Description
Satisfaction
Timepoint
Ruler 6 parts
Method of measurement
Before discharge
Intervention groups
1
Description
Interventions: The intervention group acupressure will be done for 20 minutes in L14 point. During this time all Specified points lies under pressure for 10 seconds and rest for 2 seconds respectively. Interventions for all samples were done by a single researcher to prevent of any bias as much as possible. Intensity of pain is measured by using the ruler of the (VAS) by a trained person who had no information in the type of intervention (touch or pressure) of both groups (control and test groups). Patients in group received routine care and the amount of narcotic and analgesic drugs recorded.
Category
Rehabilitation
2
Description
Control group: This group of touch LI4 point is used within 20 minutes.The pain intensity was measured using VAS ruler. The group has been part of routine care and analgesic amount is recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital
Full name of responsible person
Somayeh Ramezani
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square,shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud .
City
Shahroud
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; Shahroud 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
Shahroud university of medical sciences
Full name of responsible person
Somayeh Ramezani
Position
MAster science of student counseling midwifery
Other areas of specialty/work
Street address
Central building ofShahroud university of medical sciences, Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 7213
Fax
Email
s.ramezani82@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Ahmad Khosravi
Position
Faculty member
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
Email
a.khosravi@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Somayeh Ramezani
Position
Master science ofstudent counseling midwifery
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 7213
Fax
Email
s.ramezani82@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)