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A comparison of the Effect of foot reflexology massage and acupressure in hand Shen Men point on the quality of sleep in Patients Undergoing hemodialysis

Protocol summary

Study aim
A comparison of the Effect of foot reflexology massage and acupressure in hand Shen Men point on the quality of Sleep in Patients undergoing hemodialysis.
Design
90 patients on hemodialysis therapy who are eligible for research are selected from kidney care dialysis centers. Then, the patients are randomly divided into three groups: reflexology massage, acupressure and control, and each patient receives a specific number.
Settings and conduct
1 hour after starting dialysis 3 days a week for 4 weeks,10 minutes pressure in hand Shen Men point (acupressure) and foot thump pineal gland (reflexology massage) are performed in the dialysis center while the patient is in supine position and takes five deep breaths,s but the control group receives no treatment.
Participants/Inclusion and exclusion criteria
A 6-month history of dialysis, a total score of "5" or more in The Pittsburgh Sleep Quality Index, enjoying full awareness, lack of mental disorders and a history of illnesses that affect on sleep , no alternative and complementary therapies, no drug abuse؛ unwillingness to cooperate, traveling, death, presence of a traumatic stress or transitioning to intensive care unit in order to have an organ transplantation procedure.
Intervention groups
90 patients on dialysis are divided into intervention and control groups for comparing the effect of therapies on their sleep quality, . There is no treatment in control group except for daily care. In acupressure in hand Shen Men point group each wrist is pressured by the thump for 5 minutes (both wrists are pressured for 10 minutes) continuously in a rotational manner (2 rotations per second) and in foot thump Pineal gland reflexology massage group each foot is massaged slowly and in a regular rhythm for 5 minutes.
Main outcome variables
Due to its simplicity and safeness, and also the prevalence of sleep disorders, this method is a preferred one for sleep quality improvement.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171220037980N1
Registration date: 2018-01-25, 1396/11/05
Registration timing: retrospective

Last update: 2018-01-25, 1396/11/05
Update count: 0
Registration date
2018-01-25, 1396/11/05
Registrant information
Name
Masoumeh Emamverdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 4508
Email address
m.emamverdi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the Effect of foot reflexology massage and acupressure in hand Shen Men point on the quality of sleep in Patients Undergoing hemodialysis
Public title
"A comparison of the Effect of foot reflexology massage and Acupressure in hand Shen Men point on the quality of sleep"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having dialysis treatment for at least 6 months and having a medical record in the referral centers Having a total score of "5" or more in Pittsburgh Sleep Quality Index Enjoying full consciousness and having the ability of hearing and speaking Lacking mental disorders and not using daily neurological drugs Lacking a history of diseases that affect on sleep including cancer, skin disease, advanced heart failure, insulin- dependent diabetes and brain attack Lacking limbs amputation at the site of intervention or presence of acute infections and coagulation disorders Non-use of other alternative and complimentary therapies People who have at least the ability to read and write No drug abuse
Exclusion criteria:
Unwillingness to continue cooperation during the study period Transitioning to intensive care unit in order to have an organ transplantation procedure Patient death Travelling Presence of a traumatic stress that results in sleep disorder Use of any hypnotic medicines that affect on sleep during the study period
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: 25
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step according to a convenience target based sampling method In terms of entry criteria then by a simple random sampling (choosing randomly from the list of the patients), the patients are divided into three equal groups including reflexology, acupressure and control groups.
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences , Asian Road, Gonabad , Khorassan Razavi.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.GMU.REC.1396.65

Health conditions studied

1

Description of health condition studied
Sleep Quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The percentage of people whose total score of "5" or more in the Pittsburgh Sleep Quality Index.
Timepoint
The sleep quality will be measured at the beginning of the study (before intervention) and middle of intervention (completion of 2 weeks) and at the end of intervention (completion of 4 weeks).
Method of measurement
Pittsburgh Sleep Quality Index Questionnaire .

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Intervention in the acupressure group will be performed 1 hour after the start of dialysis,,3 days a week and for a period of 4 weeks. First, the patient lies in a supine position and takes 5 deep breaths then acupressure in hand Shen Men point of each wrist crease is pressured by a finger by a level of 3-4 kg continuously for 5 minutes 2 rotations per second.
Category
Lifestyle

2

Description
Second intervention group: Intervention in the reflexology massage group will be performed 1 hour after the start of dialysis, 3 days a week, for 4 weeks. First, the patient lies in a supine position and take 5 deep breaths, then the foot thump pineal gland, will be massaged for 5 minutes with a slow and regular rhythm and in a depth which is tolerable for the patient.
Category
Lifestyle

3

Description
Control group: There will be no intervention except for daily care,.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
dialysis Center of Moheban
Full name of responsible person
Hoshang Arian
Street address
between Ghaffari and Reza, Besat Boulevard, Ahmad Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735333
Phone
+98 51 3840 4151
Email
hoshang_arian@yahoo.com

2

Recruitment center
Name of recruitment center
dialysis Center of Shafa Toos
Full name of responsible person
Mohamad Baqir Najar Zadeh
Street address
Ghaem 12, Ghaem St, Ahmad Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183895349
Phone
+98 51 3847 1805
Email
Asndr392770@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Mohammad pur
Street address
Gonabad University of Medical Sciences, Asian Road border, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0578
Fax
+98 51 5722 0578
Email
dr.mohammadpour@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Masoumeh Emamverdi
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 38, Fallahi 1, Qasem Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735333
Phone
+98 51 3523 4508
Email
m.emamverdi@gmail.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Masoumeh Emamverdi
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 2, No. 38, Fallahi 1.2, Fallah 1
City
Mashhad
Province
Razavi Khorasan
Postal code
91735333
Phone
+98 51 3523 4508
Fax
Email
m.emamverdi@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Masoumeh Emamverdi
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 2, No. 38, Fallahi 1.2, Fallah 1
City
Mashhad
Province
Razavi Khorasan
Postal code
91735333
Phone
+98 51 3523 4508
Fax
Email
m.emamverdi@gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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