This study is a non-randomized clinical trial. The aim of this study is to determine the effect of foot reflexology massage on sleep quality. The study population are women aged over 65 years who have Restless Legs Syndrome and sleep disorder. The sampling is done continuously available. Target sample size is 70 and trial recruitment centers are Shiraz nursing homes. Inclusion criterias are: sleep disorder for 1 year or more; restless leg syndrome for 1 year or more; No Experience of Foot Reflexology Massage; No Cognitive impairment; No alcohol and substance abuse; Lack of mental illness; Able to understand persian language; Having healthy feet. Exclusion criterias are: complex problems in foot during the intervention; Neuropathy or peripheral vascular disease of the lower extremities during the study period; Taking tricyclic antidepressants, selective serotonin reuptake inhibitors, antiemetic, anticonvulsants, antidepressants, dopamine antagonists; lack of willingness to continue cooperation; diseases that affect the quality of sleep during the intervention. Intervention group will receive reflexology massage in 8 sessions (each sessions: 20 Minute) in 4 weeks. The intervention will be done at evening (3 to 7 pm). Control group will receive routine cares. Before the first intervention, demographic check list, ATMs questioner and pretest for sleep quality will be completed for each person. In the fifth week, sleep quality will be evaluated by posttest.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032733154N1
Registration date:2017-06-18, 1396/03/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-18, 1396/03/28
Registrant information
Name
Amine Abbasi Fakhravari
Name of organization / entity
Nursing school, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1820
Email address
abbasifakhavari.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research- Iran University of Medical Science
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-18, 1396/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology Massage on Sleep Quality of Elderly Women with Restless Legs Syndrome
Public title
The Effect of Foot Reflexology Massage on Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: sleep disorder for 1 year or more; restless leg syndrome for 1 year or more; No Experience of Foot Reflexology Massage for treating RLS or sleep disorder; No Cognitive impairment; No alcohol and substance abuse; Lack of mental illness; Able to understand persian language; Having healthy feet. Exclusion criteria: Ulceration, infection or complex problems in foot during the intervention; Neuropathy or peripheral vascular disease of the lower extremities during the study period; Taking tricyclic antidepressants, selective serotonin reuptake inhibitors, antiemetic, anticonvulsants, antidepressants, dopamine antagonists; lack of willingness to continue cooperation; Complications, disorders and diseases that affect the quality of sleep during the intervention
Age
From 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not 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
Ethics committee of the Iran University of Medical Science
Street address
Iran University of Medical Sciences, between the intersection of Chamran and Sheikh fazl o lah, Hemat highway
City
Tehran
Postal code
Approval date
2016-07-26, 1395/05/05
Ethics committee reference number
IR.IUMS.REC.1395,9411580005
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]
Primary outcomes
1
Description
Improving in sleep quality
Timepoint
before the intervention and a week after intervention
Method of measurement
Pittsburgh sleep quality index
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group will receive reflexology massage in 8 sessions (each sessions: 20 Minute) in 4 weeks. the intervention will be done at evening (3 to 7 pm).
in each session At first, General massage with an ineffective Lotion will be done by reasercher for 5 minutes for each foot. after that, Special reflexology for sleep will be done for 5 minutes
Category
Other
2
Description
Patient in control group will receive routine cares.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farzanegan nursing home
Full name of responsible person
Etemad
Street address
Number 5, Technology street, Mirzaye shirazi Boulevard, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Yashaye Sepid Nursing Home
Full name of responsible person
Tajer
Street address
Number 3, 7th Alley, Kebar Martyr street, Maaliabad, Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Mehr Nursing Home
Full name of responsible person
Dehghan
Street address
Number 5, Alley 11, Southern Hemat, Shiraz
City
Shiraz
4
Recruitment center
Name of recruitment center
Fereshtegan Nursing Home
Full name of responsible person
Zarei
Street address
Number1, Alley 2, Soroush Avenue, Amir Kabir Boulevard, Shiraz
City
Shiraz
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
Iran University of Medical Sciences, 5th Floor, between intersection of Chamran and Sheikh fazl o lah, Hemat 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
Nursing school, Iran University of Medical Sciences
Full name of responsible person
Amine Abbasi Fakhravari
Position
Master student of Geriatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street