This critical trial study has performed in the emergency department of the Emam Reza Hospital, in Mashhad in 2013. The inclusion criteria were age between 15 to 60 years old; the diagnosis of appendicitis; appendectomy by a single surgeon and full consciousness and some other conditions, and the exclusion criteria were use of sedative before the intervention, discharged earlier than 24 hours and some other conditions. In intervention group a specific area in the right leg and Shenman part of the ear was pressed for ten and one minute respectively. In the control group the pressure was applied on the back of left foot and right earlobe. Patients in the control group received only routine care. Pain level and analgesic intake of 105 patients were compared in three groups before, immediately, one, six and 24 hours after treatment The results were evaluated at 95% confidence level. Data analysis was performed with SPSS 21 software
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122615946N1
Registration date:2014-05-28, 1393/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-28, 1393/03/07
Registrant information
Name
Sara Baghani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1609 1195
Email address
baghanis2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Siences
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Reflexology Massage on Post operative Appendectomy pain
Public title
Effect of Reflexology Massage on Post operative Appendectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : age between 15 to 60, the diagnosis of appendicitis, appendectomy by a single surgeon and full consciousness.
exclusion criteria: Previous surgery, addiction, emotional disorders, diabetes, mental disorders, age below 15 years and above 60 years of age, spinal anesthesia, the patient's unwillingness to participate in the study, history of reflexology massage, having chronic pain in other body regions, sensitivity to touch or massage, having fever and skin diseases, pregnancy, severe complications after the surgery, a member of the feet and hands health disorders, hearing disorders and get home before the intervention
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Siences
Street address
School of Nursing and Midwifery; next to the Police station to SHahroud road, Sabzevar
City
Sabzavar
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
medsab.Rec.92.4
Health conditions studied
1
Description of health condition studied
Appendectomy
ICD-10 code
K35.3
ICD-10 code description
Acute appendicitis with localized peritonitis
Primary outcomes
1
Description
Pain
Timepoint
before intervention, 0, 1, 6 and 24 hours after itervention
Method of measurement
0-10 visual analog scale
Secondary outcomes
1
Description
Sedative consumptin
Timepoint
before intervention, 0, 1, 6 and 24 hours after itervention
Method of measurement
Review patient file
Intervention groups
1
Description
In intervention group pain intensity was recorded, then the patient's right leg in a certain area was pressed by the therapist who has been trained by a specialist for ten minutes by a special mean (steak). Also a ear seed put on certain points on the ear (shenmen) and was pressed for a minute.
Category
Treatment - Other
2
Description
The control group received only routine care.
Category
N/A
3
Description
Patients in the placebo group had a pressure point on the back of the left leg that was pressed with less intensity. ear seed was attached to the left earlobe of a patient without compression balls and other methods were performed for this group in the same way.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Street address
Imam Square - Ibn Sina Street - Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Siences
Full name of responsible person
Mosa Alreza Tadayon far
Street address
Sabzevar University of Medical Siences
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Siences
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
Sabzevar University of Medical Sciences
Full name of responsible person
Sara Baghani
Position
MSc
Other areas of specialty/work
Street address
Complementary Medicine Research Centre -Imam Square - Ibn Sina Street - Mashhad
City
Mashhad
Postal code
Phone
+98 51 1609 1195
Fax
Email
baghani_sara@yahoo.com; baghanis2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Khoorsand Vakilzadeh
Position
Assistant professor/ clinical PhD of chinese medicine and acupuncture
Other areas of specialty/work
Street address
Department of TCM- razi street-Mashhad
City
Mashhad
Postal code
Phone
+98 51 1854 3031
Fax
Email
khorsanda@mums.ac.ir; ali_khoorsand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Complementary Medicine Research Centre
Full name of responsible person
Sara Baghani
Position
Master of Science
Other areas of specialty/work
Street address
Complementary Medicine Research Centre-Emam Reza hospital-Mashhad