Objective: This study aimed to compare the effects of foot reflexology on pain intensity in patients after surgery and appendectomy.
Field of study: randomized trial, double-blinded, not placebo-controlled, single-center, phase one trial.
A) The population study: Patients undergoing appendectomy.
Inclusion criteria: consent to participate in the study; no drug addiction; having healthy hand and feet; not having the experiences of Diabetes more than 15 years.
Exclusion criteria: Withdrawal the patient; patient death; severe complications after surgery.
Sample size: 97
B) Intervention: Comparison of the effect of foot and hand reflexology on the pain intensity of patients after appendectomy surgery.
C) Study time: from the 15 December 2016 to 15 June 2017 year.
D) The primary outcome: Pain relief of appendectomy surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121031328N2
Registration date:2017-07-27, 1396/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of foot and hand reflexology on the pain intensity after appendectomy
Public title
Comparing the effect of foot and hand reflexology on pain intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in the study; no drug addiction; having healthy hand and feet; not having the experiences of Diabetes more than 15 years.
Exclusion criteria: Withdrawal the patient; patient death; severe complications after surgery.
Age
From 14 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization by blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al hoda St, Arak
City
Arak
Postal code
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
IR.ARAKMU.REC.1395.294
Health conditions studied
1
Description of health condition studied
Appendectomy
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Pain
Timepoint
Before the reflexology, one hour, 3 hours and 24 hours after the reflexology
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Foot reflexology massage for 20 minutes in both foot.
Category
Rehabilitation
2
Description
Second intervention group: Hand reflexology massage for 20 minutes in both hand.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayat allah Alimoradian Hospital
Full name of responsible person
Head of the hospital, Dr siamak daneshvar
Street address
Ayat allah Alimoradian Hospital, Janbaz Sq, Parastar St
City
Nahavand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Street address
Great Prophit University Complex, Sardasht Region, Arak
City
Arak
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 Arak 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
Vice Chancelor for Research of Arak University of Medical Sciences
Full name of responsible person
Dr.Ali arash Anooshirvani
Position
Ph.D of Medical Oncology, Vice Chancelor for Research of Arak University of Medical Sciences
Other areas of specialty/work
Street address
Arak, Sardasht, Faculty of Nursing and Midwifery
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mahbobeh Sajadi
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht Region, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mahbobeh Sajadi
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht Region, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)