This study is a randomized control trial to determine the effect of nursing consultation on Anxiety and depression of Tracheostomy patient’s families. All of the Tracheostomy patient’s families admitted in Shahid-rajaei Hospital in Shiraz city were our statistical research community. Of them, 60 patients were selected based on inclusion criteria included: The main caregiver of the patient in the hospital and at home, the ability to speak and understand the Persian language and not having a history of psychological problems and they were randomly divided into two experimental and control groups using table of random numbers. The intervention group received In-person and telephone counseling, In-person and telephone Education and in-person answering. Patient companions filled out Beck Depression Inventory and Spiel Berger Anxiety Inventory before and after the intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072535292N1
Registration date:2017-07-28, 1396/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-28, 1396/05/06
Registrant information
Name
Mina Sadeghi
Name of organization / entity
Islamic Azad University Isfahan (Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 71 3844 3313
Email address
mina.sadeghi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University Isfahan (Khorasgan) Branch
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing consultation on Anxiety and depression of Tracheostomy patient’s families
Public title
The effect of nursing consultation on Anxiety and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Ability and willingness to communicate effectively with researcher; Main role of supporting the patient in the hospital and after discharge; ability to speak and understand Persian language; lack of history of psychological problems or known anxiety disorders based on history and self-declaration;. Exclusion criteria: withdrawal to continue cooperation; receive any Consultation from other nurses and patient's death.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers was used For randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
Postal code
8155139998
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
23810403922008
Health conditions studied
1
Description of health condition studied
Tracheostomy
ICD-10 code
Z93.0
ICD-10 code description
Tracheostomy status
Primary outcomes
1
Description
Depression
Timepoint
before and one month after intervention
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
before and one month after intervention
Method of measurement
Eshpel Burgers' anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received In-person and telephone counseling, In-person and telephone Education and in-person answering
Category
Rehabilitation
2
Description
Control group: There was no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
mina Sadeghi
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Isfahan (Khorasgan) Branch
Full name of responsible person
Mina Sadeghi
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
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, Islamic Azad University Isfahan (Khorasgan) Branch
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
Islamic Azad University Isfahan (Khorasgan) Branch
Full name of responsible person
Mina sadeghi
Position
Master student of nursing
Other areas of specialty/work
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3535 4002
Fax
Email
m.sadeghi4283@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Isfahan (Khorasgan) Branch
Full name of responsible person
Shayesteh Salehi
Position
PhD of Educational management
Other areas of specialty/work
Street address
Ahmad Abad St, Daneshgah Blvd, Isfhaan
City
Isfhaan
Postal code
Phone
+98 31 3535 4001
Fax
Email
sh.salehi@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Isfahan (Khorasgan) Branch
Full name of responsible person
Mina Sadeghi
Position
Master student of nursing
Other areas of specialty/work
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3535 4001
Fax
Email
m.sadeghi4283@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)