The objective of this clinical trial is to compare the effects of foot reflexology massage and Benson relaxation on reducing pain after Caesarean section. The study population was women undergoing cesarean section in the Baqiyatallah hospital. Ninety participants were randomly assigned to foot reflexology massage, Benson relaxation, or control groups. In the foot reflexology massage group, patients were placed in a comfortable position and both feet are messaged for ten minutes. In the Benson relaxation group after providing completely calm and quiet environment, the patients were asked to follow instructions and explanations of cassette operation during the implementation period to maintain their focus on relaxation for twenty minutes. Pain was evaluated immediately after reflexology massage and Benson relaxation. The control group did not receive any type of intervention and only intensity of pain was measured after twenty minute interval. The interventions were done twice a day for two days with 6-8 hours interval.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904124299N1
Registration date:2010-08-29, 1389/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-29, 1389/06/07
Registrant information
Name
Jamileh Mokhtari Nouri
Name of organization / entity
Baghiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 248 8525
Email address
mokhtari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiatallah University of Medical Sciences
Expected recruitment start date
2006-09-20, 1385/06/29
Expected recruitment end date
2006-11-07, 1385/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of impact of Foot Reflexology Massage and Bensone Relaxation on severity of pain after cesarean section
Public title
Impact of Foot Reflexology Massage and Bensone Relaxation on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having middle and higher levels of pain, no sensory or motor disorder
Exclusion criteria: Unwillingness to participate or continue
Age
From 26 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Baqiatallah University of Medical Sciences
Street address
Araj Square, Aghdasieh
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
301
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
pre and post intervention
Method of measurement
pain scale 1-10
Secondary outcomes
empty
Intervention groups
1
Description
In the foot reflexology massage group, patients were placed in a comfortable position and both feet are messaged for ten minutes, twice a day for two days with 6-8 hours interval
Category
Other
2
Description
In Benson relaxation group after providing completely calm and quiet environment and minimizing environmental stimulation a sound player and a cassette were given to the patients. The patients were asked to follow the instruction and explanations of the cassette consisting breathing exercises, twice a day for two days with 6-8 hours interval.
Category
Other
3
Description
The control group did not receive any type of intervention and only intensity of pain was measured after twenty minute interval.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiatallah Hospital
Full name of responsible person
Jamileh Mokhtari
Street address
Araj Square, Aghdasieh
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Hossein Majedi
Street address
Sheikh Bahaii, Vanak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiatallah 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
Nursing School
Full name of responsible person
Jamileh Mokhtari
Position
MsC/faculty member
Other areas of specialty/work
Street address
Araj Square, Aghdasieh
City
Tehran
Postal code
Phone
+98 22289941
Fax
Email
mokhtari@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Jamileh Mokhtari
Position
MsC
Other areas of specialty/work
Street address
Araj, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
mokhtari@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Masood Siratinir
Position
MsC/faculty member
Other areas of specialty/work
Street address
Araj Square, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 2228 9943
Fax
Email
mokhtari@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)