Protocol summary

Summary
This study was conducted to investigate efficacy of head and face massage on agitation improvement in elderly .This work is a clinical trial research for which random sampling process was carried out on 70 samples using software. The instrument applied in this research involves a demographic questionnaire and VAS pain score, CMAI questionnaire , which are filled out by the researcher for each patient at the beginning of the study to find out their qualification for entering to the study. Then, for subjects in test group, acupressure was performed 10 days and every day for ten minutes (The period of Evening ) for patients in the intervention group will be implemented. For the control group, no intervention will be done . For each research trial, 13 Brawn massage therapy techniques (which are a combination of effleurage and pressure) would be performed by a trained agent for 10 minutes on the head and face of patients. At the end of 10 meeting participants using questionnaires agitation immediately Cohen - Mansfield (CMAI), visual pain scale (VAS) are evaluated. Inclusion criteria for this study were diagnosed Alzheimer's disease by a neurologist, mild or moderate Alzheimer's disease, the age of 60 years and older, nursing home residents Mehriz and Taft Cities , being restless. Exclusion criteria include: unwillingness of elders to participate in the study, having mental retardation and a wound in the head and face, going to a brief release, discharge from the facility.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062728673N1
Registration date: 2017-02-09, 1395/11/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Saeed Keshavarz
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0040
Email address
keshavarz.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University Medical of Scince
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of facial and head massage on agitation in elderly with Alzheimer's Disease
Public title
Determine the effect of agitation facial and head massage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for this study :Alzheimer's disease dignosed by a neurologist, mild or moderate Alzheimer's disease, the age of 60 years and older, nursing home residents and city Mehriz Taft, restless exclusion criteria include: Unwillingness of elders to participate in the study, having mental retardation and a wound in the head and face, going to a brief release, discharge from the facility.
Age
From 60 years old to 103 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method: After the selection of eligible, patients with random assignment method using the software, Random Allocation will be divided into two groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Central Intelligence Agency, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.RUMS.REC.1395

Health conditions studied

1

Description of health condition studied
Agitation in Alzheimer's disease
ICD-10 code
G00, G99
ICD-10 code description
Agitation in Alzheimer's disease

Primary outcomes

1

Description
agitation
Timepoint
During the two weeks before and immediately after intervention
Method of measurement
Cohen Mansfield questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, the intervention is not done.
Category
N/A

2

Description
In the intervention group, facial and head massage for ten minutes every day for ten days and will be implemented in the course of the evening.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing Home Center Of Mehriz City
Full name of responsible person
Ahmad Abooee
Street address
Home for the elderly and disabled vitality Mehriz, next to Green Hall , Mehriz, Yazd
City
Mehriz

2

Recruitment center
Name of recruitment center
Charity Fatemeh Zahra Taft City
Full name of responsible person
Alireza Ghorbani
Street address
Next Payame Noor University, Taft, 10 km road Yazd, Yazd
City
Taft

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hakimi
Street address
Central Organization for Medical Sciences, Building No. 3, Department of Education and Research
City
Rafsanjan
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 Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Saeed Keshavarz
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Crossroads Mozaeic Sazi, Imam Street, Yazd
City
Yazd
Postal code
Phone
+98 353165252
Fax
Email
saeedkeshavarz1990@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebe Mirzaei
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafsanjan Nursing College
City
Rafsanjan
Postal code
7718796755
Phone
+98 34 3425 6961
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir; mirzaei_t@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Saeed Keshavarz
Position
Nursing Post Graduate Student
Other areas of specialty/work
Street address
Mosaic Sazi Intersection, Imam Street, Yazd
City
Yazd
Postal code
8914718883
Phone
+98 939 035 5181
Fax
Email
Saeedkeshavarz1990@yahoo.com
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
empty
Analytic Code
empty
Data Dictionary
empty
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