The present research is conducted for detemining the effect of foot massage on sleeping in hemodialysis patients in Khoram abbad. Key criteria for entering the study including: willingness to cooperate and participatie in research; having sleeping problems based on scores resulting from Pittsburg questionnaire; age above 18 years and below 65 years; not using hypnotic drugs and exclusion key criteria including: not wanting to continue working; referring to another facility for futher treatment; having undiagnosed illnesses. This experimental clinical trial was conducted on 80 hemodialysis patients admitted to the hemodialysis units affiliated to Lorestan University of Medical Sciences, Iran (2013). Tools were included Pittsburg questionnaire and sleep log.
The treatment was Stroke foot massage carried out during hemodialysis for 10 minutes three times a week, for four consecutive weeks in experimental group and in control group Alprazolam 0.5 mg/oral before sleeping for four consecutive weeks was used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031516983N1
Registration date:2014-09-08, 1393/06/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Farhad Ariamanesh
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1423 3808
Email address
malekshahif@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage on sleep quality in hemodialysis patients
Public title
The effect of foot massage on sleep quality in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to cooaperate and participate in research; giving informed consent; having sleep problems based on scores resulting from Pittsburg questionnaire; performing hemodialysis in the evening and night shifts; lack of amputation, injury, infection, wound and skin disease in the lower limbs; insensitive to massage and having endurance against massage by patient; not having clotting disorders, vascular, neuropathy and diabetes complications; age above 18 years and below 65 years; no history of psychiatric disorders or psychiatric hospitalization; not using hypnotic drugs.
Exclusion criteria: Not wanting to continue working; referring to another facility for futher treatment; referring patients for kidney transplantation; having undiagnosed illnesses.
Age
From 18 years old to 65 years old
Gender
Both
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
4th kilometers, Khoram Abbad-Brojerd Road
City
Khoram Abbad
Postal code
6813833946
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
99149/200
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
F51.0
ICD-10 code description
Nonorganic insomnia
Primary outcomes
1
Description
Lack of sleep
Timepoint
Before intervention, a week later, two weeks later, three weeks later and four weeks later after beginning of intervention
Method of measurement
By using Pittsburg and Sleep Log
Secondary outcomes
1
Description
Improving sleep Quality
Timepoint
Weekly
Method of measurement
By using Pittsburg and Sleep Log
Intervention groups
1
Description
In this study, Stroke foot massage was conducted in experimental group. Intervention was 5 minutes Stroke foot massage, three times a week for four excutive days in the evening and night shifts (because of closeness to the night sleeping hours) among male patients by researcher and female patients by trained female partner after declaration of patient readiness. Stroke foot massage perfomed in the sole of the foot with a mild to moderate pressure slowly and regularly in every direction.
Category
Treatment - Other
2
Description
In this study, in control group, Alprazolam 0/5 mg/oral before sleeping for four consecutive weeks was used.