The aim of this study is to determine the effect of reflexology and foot bath to improve sleep quality in elderly. Aged 60 years and older referred to Tabriz health centers and older people that are healthy in all aspects of touch; hearing; sight and mental were include in study and seniors who were taking sleep medications or herbal medicine for sleep disorders or other alternative and complementary therapies used for sleep disorders were excluded. This study is a single-blind clinical randomized controlled trial that using of the Pittsburgh sleep qualit questionnaire whit two groups (reflexology and foot bath) and a control group will be performed on 96 elderly. Intervention sessions of reflexology as 6 weeks, once a week for 20 minutes with olive oil for each leg will be done. In foot bath group after training; participants will be asked 6 weeks every night one hour before the usual time sleeping soaking your feet 10 centimeters above the ankle for 20 minutes in warm water with a temperature of 41 to 42 degrees celsius with the temperature on the thermometer that has been flagged by the researcher. participants will follow up by phone. Questionnaire for all three groups after 6 weeks to be completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210046918N13
Registration date:2013-01-03, 1391/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of reflexology and foot bath to improve sleep quality in elderly
Public title
Quality of Sleep in Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 60 years and older; Elderly resident referring to Tabriz health centers and suburbs;Relative independence in activities of daily living; Having the desire and interest to participate in the study; Not working at night Exclusion criteria:Taking sleeping medications or herbal remedies for sleep disorders; Having a mental illness and Severe nacturia and Asthma; Having trouble hearing and vision; The use of other complementary therapies such as relaxation effects and hot showers and massage other body parts and music and sports and walk before bedtime to improve sleep quality;Having diabetes; having a sensory impairment
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Deputy for Research, Tabriz University of Medical Sciences
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Deputy of Medical Sciences University of Tabriz
City
Tabriz
Postal code
Approval date
2012-11-30, 1391/09/10
Ethics committee reference number
45/7/1047
Health conditions studied
1
Description of health condition studied
Quality of Sleep
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Before intervention and 6 week after intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Reflexology intervention will be by the researcher for 6 weeks; once a week for 20 minutes with olive oil for each foot.
Category
Other
2
Description
In foot bath group after training; participants will be asked 6 weeks every night one hour before the usual time sleeping soaking your feet 10 centimeters above the ankle for 20 minutes in warm water with a temperature of 41 to 42 degrees celsius with the temperature on the thermometer that has been flagged by the researcher.
Category
Other
3
Description
In control group was not intervention performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Khadijeh Nasiri
Street address
Shariety South St ; Faculty of Nursing & Midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Kazem Shakori
Street address
Deputy of Medical Sciences University of Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariety Faculty of Nursing & Midwifery
Full name of responsible person
Alehe Seyyedrasooli
Position
Ms
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing & Midwifery
City
Tabriz
Postal code
Phone
+98 41 1479 6969
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)