Delirium causes hospitalization of 2.3 million people annually, which amounts to 17.5 million days of hospitalization leading to about 4 billion dollars of medical care cost.
Treatment of delirium involves medications and supplementary drugs. Massage therapy is among the complimentary traditional medicine, which is recommended as an effective and safe treatment, according to many works. This study was conducted to investigate efficacy of head and face massage on delirium improvement in elderly inpatient women in CCU.
This work is a clinical trial research for which random sampling process was carried out on 88 samples through the coding approach; i.e., the odd and even numbers indicate members of test and control groups, respectively. The instrument applied in this research involves a demographic questionnaire and standard Neecham 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 four times (twice at 10:00 a.m. and twice at 6:00 p.m.) each for 15 minutes. 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 15 minutes on the head and face of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051922320N1
Registration date:2015-08-20, 1394/05/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-20, 1394/05/29
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2015-05-14, 1394/02/24
Expected recruitment end date
2015-07-15, 1394/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of facial and head massage on improving Delirium in elderly women hospitalized in Coronary Care units
Public title
The effect of facial and head massage on improving Delirium in elderly women hospitalized in Coronary Care units
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria are: no opium and alcohol dependency; no visual and auditory lesion; no history of cognitive impairment; no history of psychological disease; and no history of psychoeffective drug use.
exclusion criteria are: head and face lesions
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Emam Ali Bolv
City
Rafsanjan
Postal code
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
IR.RUMS.REC.1
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.9
ICD-10 code description
Delirium, unspecified
Primary outcomes
1
Description
Delirium
Timepoint
After 2 times of intervention
Method of measurement
Neecham questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For subjects in test group, massage therapy was performed four times (twice at 10:00 a.m. and twice at 6:00 p.m.) each for 15 minutes.
Category
Treatment - Other
2
Description
Control group only received routine treatments.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani hospital
Full name of responsible person
Fakhri Torki
Street address
kashni street
City
Isfahan
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Neda Eslami
Street address
Sofeh Street
City
Isfahan
3
Recruitment center
Name of recruitment center
Chamran
Full name of responsible person
Dr MohamadReza Akhbari
Street address
Moshtagh second Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
PhD, assistant professor
Other areas of specialty/work
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.mirzaei@rums.ac.irmirzaei_t@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)