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Effect of acupressure on sleep quality in women with multiple sclerosis in Isfahan MS society

Protocol summary

Summary
Multiple sclerosis (MS) is a neurological, chronic and progressive disease that results from collection of environmental, genetic and autoimmune factors. The disease, commonly affects people between the age of 20 and 50 years. Common symptoms of MS, which will greatly reduce the quality of life is sleep disorders and poor quality of sleep. Acupressure as a branch of acupuncture is non-pharmacological approach that use in relieving some symptoms including quality of sleep. Therefore, this randomized controlled trial will determine the effect of acupressure on quality of sleep in women with MS. The subjects of this clinical trial (The women with the age of 20-50 years old, the sleep quality score should be 5 or more, Ability for reading and writing) randomly assign into the acupressure group (n=50), which receive acupressure at the true point (shen-men), or the placebo group (n=50), which receive touching instead of acupressure at placebo point. Quality of sleep is main outcome that measure in both groups before and after intervention with Pittsburgh Scale. The women who do not continue the trial for any reason, or the participants who do not feel the heavy and numbness during the intervention at the shen-men point or women that do not perform intervention for more than three nights will be excluded. In the experimental group, participants will be trained for the intervention (acupressure) which is pressing about five minutes at Shen-men point for each side of the body once at night for four consecutive weeks by themselves. The similar procedure that is touching beside of Shen-men point will be implemented for the placebo group.

General information

Acronym
MS
IRCT registration information
IRCT registration number: IRCT201204256247N5
Registration date: 2012-09-15, 1391/06/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-15, 1391/06/25
Registrant information
Name
Farideh Bastani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 2278
Email address
f-bastani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University Of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on sleep quality in women with multiple sclerosis in Isfahan MS society
Public title
Acupressure and sleep quality in women with multiple sclerosis (MS)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria consisted of: The age between 20-50 years old, The sleep quality score should be 5 or more (with any medication), six months past from diagnosis of Multiple Sclerosis in women, No presence of scars, scratches and deformity in the area of the point of Shen-men for the experimental or placebo groups, Ability for reading and writing (literate), No previous experiences of acupressure in the participants, No history of mental illnesses, physical diseases such as depression, insulin-dependent diabetes, heart failure or chronic pain in the women, and the EDSS score should be between 1- 4.5. Exclusion criteria: Lack of willingness to continue participation in the trial for any reason, Patients who do acupressure in the Shen-men point do not have warmth, heaviness, swelling, and numbness with any reason, Patients with more than 3 nights, do not perform the intervention, Patients during the intervention process have serious known physical and psychological disorders.
Age
From 20 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, Patients who do not have a history of using acupressure and do not have information about acupressure. The Patients assign randomly two groups. This study perform single blind.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2012-03-02, 1390/12/12
Ethics committee reference number
12269

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G35, H48.1
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Quality of sleep
Timepoint
Before the beginning of the intervention and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Scale

Secondary outcomes

empty

Intervention groups

1

Description
The women in the experimental group receive the intervention (acupressure) at the point of Shen-men for five minutes on each side of the body, once at night for four consecutive weeks.
Category
Treatment - Other

2

Description
The women in the control (placebo) group receive the intervention (touching instead of acupressure) at the beside of Shen-men point for five minutes on each side of the body, once at night for four consecutive weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan MS Society
Full name of responsible person
Dr. Etemadi
Street address
The MS Society of Isfahan, No. one, Ground Floor, Building Behesht, Bozorgmehr St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Central Organization, Ghods St., Keshavarz Blvd., Tehran, Iran
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 for research, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Dr. Farideh Bastani
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Nursing, Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
f-bastani@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Marzieh Sobhani
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing, Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
m-sobhani@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Marzieh Sobhani
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
m-sobhani@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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