The effect of nursing telephone counselling on depression and anxiety among family caregivers of patients with head trauma and cerebrovascular accident (CVA) in Shohadaye Haftome Tir hospital
Assessing the effect of nursing telephone counselling on depression and anxiety among family caregivers of patients with head trauma and cerebrovascular accident (CVA)
Design
Randomized controlled trial, parallel group, not blinded
Settings and conduct
The intervention will be done at home and through telephone counseling with 79 patients with trauma and CVA discharged from the 7-Tir Hospital during the first half of 1396. For intervention group, 24-hour nursing counseling will be provided by three nurses for 12 weeks. Both groups will complete Beck anxiety and depression questionnaires before and after the intervention and the results will be compared.
Participants/Inclusion and exclusion criteria
Inclusion: Main person in taking care of a patient with head trauma and CVA who needs daily care, Aged ≥15, Residing in Tehran, Receiving at least one nursing counselling service per week.
Exclusion: Participating in relevant patient care educational programs, history of hospitalization in psychiatric wards, receiving psychological therapies or having cognitive disorders, Experiencing loss and mourn in past six months
Intervention groups
Intervention group: Receiving 24 hours telephone counselling provided by 3 nurses for 12 weeks.
Control group: Not receiving any nursing counselling from the team members or others.
Main outcome variables
Anxiety level, depression level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181020041391N1
Registration date:2019-01-22, 1397/11/02
Registration timing:registered_while_recruiting
Last update:2019-01-22, 1397/11/02
Update count:0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Hassan Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
amiri.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-20, 1398/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing telephone counselling on depression and anxiety among family caregivers of patients with head trauma and cerebrovascular accident (CVA) in Shohadaye Haftome Tir hospital
Public title
Effects of nursing telephone counselling on depression and anxiety among patients’ family caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being a main person taking care of the patient (such as father, mother, son, daughter, son or daughter in law, brother or sister who lives with the patient)
Aged ≥15 years
Residing in Tehran
Taking care of a patient with head trauma and CVA who needs daily primary care
Being literate and able to speak and listen
Receiving at least one nursing telephone counselling service per week from the study team
Exclusion criteria:
Simultaneous participation in other psychotherapy sessions
Having a history of hospitalization in psychiatric wards or having cognitive disorders (Dementia and Delirium)
Participating in educational programs relating to patient care concurrently or in the past
Experiencing loss and mourn in past six months
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
79
Randomization (investigator's opinion)
Randomized
Randomization description
Following simple random sampling approach, a random number table will be used to generate 80 two digit random numbers. Each number will be printed in a separate card. The cards will be shuffled and a single card will be randomly picked up while eligible individuals enrolled and signed the consent form. The samples will be assigned into control and intervention groups based on the odd (intervention) and even number (control). The sample’s number and group name will be recorded and the card will be returned and merged with other cards. If the same card was picked up it will be regarded as blank. The process will be continued until all samples will be allocated to the groups.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-13, 1396/07/21
Ethics committee reference number
IR.IUMS.REC 1396.31164
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
depressive disorder
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Depression
Timepoint
Depression score before and after receiving nursing consultations
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
Anxiety score before and after receiving nursing consultations
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 24 hours telephone counselling provided by 3 nurses for 12 weeks. Telephone counseling will often be done with a request from a caregiver. Consults will be about primary nursing care at home such as suction, gavage, position change, proper feeding, physiotherapy, etc.
Category
Behavior
2
Description
Control group: Receiving routine patient education before discharge from the hospital along with educational pamphlet and CD, without receiving any 24 hours nursing telephone counselling
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Haftome Tir hospital
Full name of responsible person
Shirin Nasrollah Nezhad Tasouj
Street address
Shohadaye Haftome Tir hospital, ُRajaei Expy, Shahar-e-Rey, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
nasrolahnejhad.sh@IUMS.AC.IR
Web page address
http://iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir
Grant name
Grant code / Reference number
96-02-203-31164
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hassan Amiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran