A total of 80 potential participants will be selected from the available list of patients with migraine will be selected by convenience sampling and according to inclusion criteria: Age from 18 to 60 years; non-pregnant, non-continuous use of drugs affecting sleep; report of any accident that has affected mood and mind of the patient by him/herself; a history of migraine attacks at least twice in recent months; non-use of preventive medicine; not having psychological disorders; lack of diseases such as cancer, lupus, skin diseases and severe congestive heart failure; lack of ulcers or amputations in the concerned parts; lack of drug addiction; lack of dysarthria and hearing problem; score 5 or higher on Pittsburgh Sleep Quality Index (a score greater than 5 indicates severe sleep disorder); attainment of qualifications needed to do acupressure techniques; literacy to read and write. They will first complete demographic characteristics form and Fatigue Severity Scale (FSS). The participants will be assigned into intervention (n=40) and placebo (n=40) by blocking technique. The intervention group will receive acupressure in each of the Nei Guan and Yin Tang points three times a week for four weeks. The placebo group will have acupressure with 2.5 centimeter distance from Nei Guan point and 3 cm above Yin Tang. This technique will be performed by the patients themselves after patient education and qualification. At the end of four weeks of massage, the questionnaires will be completed by both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061117756N3
Registration date:2016-06-14, 1395/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-06-25, 1395/04/05
Expected recruitment end date
2016-07-26, 1395/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effects of acupressure on sleep quality and fatigue of patients with migraine
Public title
Effects of acupressure on sleep quality and fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age from 18 to 60 years; non-pregnant, non-continuous use of drugs affecting sleep; report of any accident that has affected mood and mind of the patient by him/herself; a history of migraine attacks at least twice in recent months; non-use of preventive medicine; not having psychological disorders; lack of diseases such as cancer, lupus, skin diseases and severe congestive heart failure; lack of ulcers or amputations in the concerned parts; lack of drug addiction; lack of dysarthria and hearing problem; score 5 or higher on Pittsburgh Sleep Quality Index (a score greater than 5 indicates severe sleep disorder); attainment of qualifications needed to do acupressure techniques; literacy to read and write.
Exclusion criteria: Disinterest to continue participation; occurrence of any problem during treatment against inclusion criteria.
Age
From 18 years old to 60 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
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
Ir.bums.1395.11
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
g47.8
ICD-10 code description
Sleep disorder, unspecified
2
Description of health condition studied
fatigue
ICD-10 code
f48.0
ICD-10 code description
Neurasthenia
Primary outcomes
1
Description
fatigue
Timepoint
four weeks
Method of measurement
Fatigue Severity Scale
2
Description
sleep quality
Timepoint
4 weeks
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will first complete demographic characteristics form and Fatigue Severity Scale (FSS). The group will receive acupressure in each of the Nei Guan and Yin Tang points three times a week for four weeks. This technique will be performed by the patients themselves after patient education and qualification. At the end of four weeks of massage, the questionnaires will be completed by group members.
Category
Rehabilitation
2
Description
The placebo group: The members will first complete demographic characteristics form and Fatigue Severity Scale (FSS). The members will have acupressure with 2.5 centimeter distance from Nei Guan point and 3 cm above Yin Tang. This technique will be performed by the patients themselves after patient education and qualification. At the end of four weeks of massage, the questionnaires will be completed by both groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Street address
Vali Asr Hospital, Ghaffari St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Deputy of Reserach, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Birjand 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, Birjand University of Medical Sciences
Full name of responsible person
Mohadeseh Salmabadi
Position
Master Student of Medical-Surgical Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences; Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohadeseh Salmabadi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohadeseh Salmabadi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)