Protocol summary

Summary
Depression is a major public health problem and a leading predictor of disability and mortality. Risk factors for depression are genetics, environment, social and therapeutic effects. Previous studies showed depression could increase Duration of hospitalization, so treating depression could improve the pace of recovery. Recently, clinical studies also showed anxiety reduction had direct relationship with patient improvement This study was conducted in infectious ward of Afzalipoor hospital and one hundred twenty of hospitalized patients participated. Their age ranged 16-55 years old. They had no psychiatric disorder recently or at the time of study and should be conscious and had no critical condition. Patient with chronic disease such as cancer, COPD, and HIV were excluded from this study. The first part of this study was cross-sectional and the effect of amount, route and frequency of medicines administration on anxiety and depression of hospitalized patients were evaluated. Anxiety and depression were measured by hospital anxiety and depression scale. The second part of this study was randomized clinical trial. Intervention group visited by clinical pharmacist and their medicines were checked and the effect of presence of clinical pharmacist on anxiety and depression of hospitalized patient were evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404216026N2
Registration date: 2014-04-23, 1393/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciencess
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of medications administration associated factors on depression and anxiety of hospitalized patients in infectious ward
Public title
Evaluation of the effect of medications administration associated factors on depression and anxiety of hospitalized patients in infectious ward
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age ranged 16-55 years old; be conscious; do not have any psychiatric disorder. Exclusion criteria: do not have any chronic disease such as cancer, HIV or COPD that cause depression.
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Keram University of Medical Sciences
Street address
Tahmasb abad Ave
City
Kerman
Postal code
Approval date
2014-04-13, 1393/01/24
Ethics committee reference number
93/10/60/2107

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

2

Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified

Primary outcomes

1

Description
depression
Timepoint
second or third day of hospitalization
Method of measurement
hospital anxiety and depression scale

2

Description
anxiety
Timepoint
second or third day of hospitalization
Method of measurement
hospital anxiety and depression scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The presence of clinical pharmacist and her effect of pharmacotherapy
Category
Other

2

Description
Control group: Absence of clinical pharmacist
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipoor hospital
Full name of responsible person
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Miz. Hasani
Street address
Tahmasb abad Ave
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 1320 5034
Fax
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 1320 5034
Fax
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 1320 5034
Fax
Email
fatemeh_dabaghzadeh@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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