This study is a randomized clinical trial. The aim of this study is to investigate the effect of foot reflexology massage on the quality of sleep of type 2 diabetic women. The sample size is 54 patients who randomly select from the diabetic center of Amiralmomenin hospital in Arak. They randomly divide into control and intervention groups. Inclusion criteria include people between the ages of 30- 65 and having no diabetic neuropathy, and exit criteria include unwillingness to continue cooperation. In the Massage group, the foot massage perform for four weeks, twice a week for 30 minutes on both legs, while the control group only receives care for the disease. Before and after intervention, Pittsburg Sleep Quality Standard Questionnaire is considered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091236148N1
Registration date:2017-10-15, 1396/07/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Fatemeh Bagheri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 1470
Email address
fatemehbagheri817@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Practice Investigating the effect of foot reflexology massage on the quality of sleep in type 2 diabetic women
Public title
The effect of massage on sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Entry Criteria: Individuals aged 30-65; People not afflicted with diabetic neuropathy; Non-chronic diseases such as rheumatoid arthritis; the absence of any complication in the leg; full awareness of time, place and person. Exit criteria: Unwillingness to continue cooperation with the researcher; the presence of complications or disorders or specific illness during the study.
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Tehran University of Medical Sciences
Street address
Tohid Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1654
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
(E00-E90)
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Sleep quality
Timepoint
One Month
Method of measurement
Standard Pittsburg Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the massage group, the foot massage is performed eight sessions. Twice a week, 30 minutes each session, for one month.
Category
Treatment - Other
2
Description
In the control group, only disease-related care is provided.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Amiralmomenin Hospital
Full name of responsible person
Fatemeh Bagheri
Street address
Sardasht, basij square, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadan Pedramrazi
Street address
Nursing University, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bagheri
Position
Master Of Nursing
Other areas of specialty/work
Street address
Jahangiri street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3610
Fax
Email
fatemehbagheri817@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bagheri
Position
Master Of Nursing
Other areas of specialty/work
Street address
Jahangiri Street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3610
Fax
Email
fatemehbagheri817@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bagheri
Position
Master Of Nursing
Other areas of specialty/work
Street address
Jahangiri street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3610
Fax
Email
fatemehbagheri817@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)