Objectives: this study will evaluate the effect of foot reflexology on anxiety of patients undergoing hemodialysis .
Design: This study is a clinical trial.
Setting and conduct: sampling in this study is Simple random sampling. In the sampling day, researcher will introduce himself to the patient and will present them objective of the study and if the patient agree to participate , they will enter the study according to the inclusion criteria and then they will fill the informed consent form. And also they will be divided into intervention and control group randomly.
Major Inclusion criteria: patients in the weekly dialysis list who will be hemodialyzed at least 3 or 4 times and will tend to participate in the study, Major exclusion criteria: being reluctant to cooperate and use of foot reflexology .
Intervention :in the intervention group, first, relaxation technique of foots will be used 2-3 time in 5 min. then foot reflexology will start with special point, the points include head point: 2 minutes, pituitary point: 30 seconds, diaphragm point: 10 times, the lungs point: 5 times , kidney and adrenal gland point 1 minute, chest ribs point: 5 times .the reflexology process will be done 30 min after the start of hemodialysis until the end of hemodialysis .
The main outcome variables; anxiety scores will be decreased based on Spielberger questionnaire
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016051127841N1
Registration date:2016-09-22, 1395/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Solmaz Bashiriyan
Name of organization / entity
Sabzevar University of Medical Sciencesو Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7010
Email address
s.barzegar@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety in patients undergoing hemodialysis
Public title
The effect of foot reflexology on anxiety in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having at least 18 years old and at least 6 months of dialysis history; tend to participate the study; patients in the weekly dialysis list who will be hemodialyzed at least 3 or 4 times.; having full consciousness; able to Listen and speak well for answering questions; The absence of fever(>37.5), bleeding , thrombosis , numbness or paralysis of the legs.; lack of any lesions in feet ; no history of depression or anxiety disorders and mental illness; Lack of fractures and infection in the lower extremities ; ability to speak in Persian; Lack of drug addiction; Lack of diabetic neuropathy ; no history of using plantar reflexology
Exclusion criteria: disinclination to cooperate and use of reflexology; Get a sedative drugs 4 hours prior to the intervention..
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
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 will be done with Randomized double blocks method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
5 km road Tehran Sabzevar, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
9613874136
Approval date
2015-09-24, 1394/07/02
Ethics committee reference number
IR.MEDSAB.REC.1394.178
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
anxiety
Timepoint
after intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: After filling informed consent form in the intervention group, first, relaxation technique of foots will be used 2-3 time in 5 min. then foot reflexology will start with special point, the points include head point: 2 minutes, pituitary point: 30 seconds, diaphragm point: 10 times, the lungs point: 5 times , kidney and adrenal gland point 1 minute, chest ribs point: 5 times .the reflexology process will be done 30 min after the start of hemodialysis until the end of hemodialysis On each point, reflexology will be done by reflexology expert in 20 minute for both foot. Reflexology will be done with help of researcher and an assistant which both passed the reflexology training course. The process will be done with an stick tool which will press the skin 2.5 kg/cm.
Category
Treatment - Other
2
Description
Control group: Without the intervention by the research team and just doing hemodialysis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital(bojnoord)
Full name of responsible person
Solmaz Bashiriyan
Street address
Imam Ali Hospital, Next to Islamic Azad University, Bojnoor Branch, Bojnoord
City
Bojnoord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Musa al-Reza Tadayyonfar
Street address
Sabzevar School of Nursing and Midwifery
City
Sabzevar
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Solmaz Bashirian
Position
Student
Other areas of specialty/work
Street address
No. 44, seyedi Nawab 9 ST, Bojnoord.
City
Bojnoord
Postal code
Phone
+98 58 3229 7010
Fax
-
Email
S.barzegar@nkums.ac.ir؛ s.bashiriyan@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Musa al-Reza Tadayyonfar
Position
Master of Nursing
Other areas of specialty/work
Street address
Building number two, EDC, Sabzevar Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
mtadayonfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Solmaz Bashirian
Position
MSc student
Other areas of specialty/work
Street address
No. 44, seyedi Nawab 9 ST, Bojnoord.
City
Bojnord
Postal code
Phone
+98 58 3229 7010
Fax
Email
S.barzegar@nkums.ac.ir؛ s.bashiriyan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)