The main objectives of the project: to determine the effect of reflexology (reflexology) on sleep disorders and pain in elderly women undergoing abdominal surgery study design: experimental clinical trial, non-random sampling, a control group and test centers. The study population consisted of older women undergoing abdominal surgery form.
Inclusion criteria; exposure to abdominal surgery due to surgical incision and duration of surgery, the point 5 of the tool above the PSQI, no interference or foot deformity, no diabetes, grade 7 and older versions of Persian short test cognitive status, their ability to report pain.
Exclusion criteria of the study; the lack of cooperation or death of the elderly, less than two days of hospital discharge after surgery, the risk of malignancy associated with any surgery, the patient needs to be hospitalized in the intensive care unit.
A sample of 80 elderly women undergoing abdominal surgery case study is reflexology massage. Since Intervention: Intervention Reflexology in the morning (an hour after breakfast) and evening (one hour before bedtime) in the second and third day of surgery and for 20 minutes each will be conducted by the researcher. Primary Outcome: Reflexology intervention in reducing sleep disorders and pain affects older women undergoing abdominal surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010325625N2
Registration date:2016-01-24, 1394/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Azadeh Kheiri
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 000000
Email address
kheiri.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Iran University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of reflexology on pain and sleep disorder in older women whith abdominal surgery
Public title
Reflexology effect on sleep disorders and pain after abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study;
Operation of the surgical incision in the abdomen, according to the length of time of operation, the point 5 of the tool above the PSQI, no disturbance or deformation of the foot (corn, burning feet, amputations and skin diseases),
The lack of a history of drug use or psychiatric disorders, absence of diabetes, lack of severe visual-auditory disorders, addiction to alcohol and drugs, having a fracture, graft and wound infections
, Mini-Mental State Examination scores Persian versions 7 and above, the ability to self-report pain
Exclusion criteria of the study;
Lack of cooperation or death of the elderly, less than two days of hospital discharge after surgery, not wanting to continue to participate in the study, any risk of malignancy associated with the surgery, the patient needs to be hospitalized in intensive care unit.
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling method in this study consecutively (targeted) will be. So that patients Inclusion criteria for the study were randomly coin toss in the hospital as one of the two groups are or control.
Secondary Ids
1
Registry name
------
Secondary trial Id
--------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Science
Street address
Between the intersection of sheikh fazlolahe nouri st. and shahid chamran st., Toward the west of Shahid Hemmat Highway, Iran University of Medical Science, Tehran, Iran
City
Tehran
Postal code
7396144859
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394.9211580203
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
2
Description of health condition studied
Pain
ICD-10 code
R10
ICD-10 code description
Severe abdominal pain (generalized)(localized)(with abdominal rigidity)
Primary outcomes
1
Description
Improving in sleep quality
Timepoint
Half an hour before the intervention and the fourth day of surgery
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Pain relief
Timepoint
Half an hour before the intervention and the fourth day of surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
intervention group; Reflexology in the morning( one hour after breakfast) and evening (one hour before bedtime) in the second and third day of surgery and for 20 minutes each will be conducted by the researcher.
Category
Other
2
Description
The control group; did not receive special treatment than the routine care of surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoul educational-medical center related to IUMS
Full name of responsible person
Azade kheiri
Street address
Hazrate Rasoul educational-medical center, At the corner of the Mansouri St, Niayesh St, Sattarkhan district, Urban area 2, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Firouzgar educational-medical center related to IUMS
Full name of responsible person
Azade kheiri
Street address
Firouzgar educational-medical center, Karimkhan zand St. to Beh-Afarin St., Vali Asr Square, Tehran, Iran Tehran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research- Iran University of Medical Science
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
The fifth floor of headquarters,Iran University of Medical Science, Between the intersection of sheikh fazlolahe nouri st. and shahid chamran st., Toward the west of Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research- Iran University of Medical Science
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
Faculty of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Azade khriri
Position
Student / M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Science, Rashid Yasemi St., ahead of the Vanak square, Vali-Asr St.
City
Tehran
Postal code
Phone
+98 51 4324 5417
Fax
Email
kheiri.a@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Farideh Baastani
Position
Ph.D / Associate Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Science, Rashid Yasemi St., ahead of the Vanak square, Vali-Asr St.
City
Tehran
Postal code
Phone
+98 13 3455 4754
Fax
Email
faridehbastani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Azade kheiri
Position
Student / M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Science, Rashid Yasemi St., ahead of the Vanak square, Vali-Asr St.
City
Tehran
Postal code
Phone
+98 51 4324 5417
Fax
Email
kheiri.a@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)