Determining the effect of clinical priest presence on depression and anxiety before and after surgery in patients admitted to the orthopedic department
Design
This clinical trial was conducted on 60 patients undergoing orthopedic surgeries at Valiasr Hospital. The intervention group will receive priest care from a clinical priest. Then, before surgery and 6 hours after the operation, the level of depression and anxiety of patients will be measured. The control group will only receive routine care.
Settings and conduct
This study will be carried out at Vali -e- Asr Hospital in Arak. The clinical trial will be conducted double blind in which the researcher and the data analyst won't know which type of care will be received by the patients in each intervention or control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being Iranian, Muslim and Shia, being at the age of 15 to 65 years, satisfaction to participate in the study, having at least elementary education, undergoing orthopedic surgery.
Exclusion criteria: addiction and underlying illness, using antidepressant drugs.
Intervention groups
Intervention group: The intervention group will receive the spiritual care provided by the clinical priest, in addition to the routine care. Prior to surgery and spiritual counseling, the patient will ask his/her questions and will receive the answers and then depression and hospital anxiety scale will be given to the patient to complete. Six hours after the surgery the questionnaires will be completed by the patient again. The control group only receives routine hospital interventions.
Main outcome variables
Anxiety, Depression, Satisfaction from health services
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037733N2
Registration date:2018-07-30, 1397/05/08
Registration timing:registered_while_recruiting
Last update:2018-07-30, 1397/05/08
Update count:0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Mehran Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.akbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clinical priest presence on depression and anxiety after surgery in patients admitted the orthopedic ward
Public title
The effect of clinical priest presence on anxiety and depression in patients undergoing orthopedic surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Being Muslim and Shia
Satisfaction to participate in the study
Patients with at least primary education
Patients who intend to perform orthopedic surgery
Being at the age of15 and 65 years
Exclusion criteria:
Addiction
other underlying illnesses
Taking antidepressant medication
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, the patients will enter into the study according to the inclusion criteria and the subjects will be randomly assigned to the intervention or control groups according to the block randomization method. Randomization will be done by a statistician and using a software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical trial is conducted double blind in which the researcher and the data analyst won't know which type of care will be received by the patients in each intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Third Floor, blue Wing, Payambar aazam University Complex, Basij Square, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2018-05-07, 1397/02/17
Ethics committee reference number
IR.ARAKMU.REC.1397.1
Health conditions studied
1
Description of health condition studied
anxiety and depression
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
depression
Timepoint
Before and after of surgery
Method of measurement
questionnaire
2
Description
anxiety
Timepoint
Before and after of surgery
Method of measurement
questionnaire
3
Description
Satisfaction with health services
Timepoint
Before and after of surgery
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive the spiritual care provided by the clinical priest, in addition to the routine care. Prior to surgery and spiritual counseling, the patient will ask his/her questions and will receive the answers and then depression and hospital anxiety scale will be given to the patient to complete. Six hours after the surgery the questionnaires will be completed by the patient again.
Category
Treatment - Other
2
Description
Control group: In this research, the control group will receive routine care only.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital in Arak
Full name of responsible person
Mehran Akbari
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3222 2003
Email
m.akbari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Deputy of research and technology, Payambar Aazam University Complex, Basij Square, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
MSc Student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar Aazam University Complex, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3477 3505
Email
m.akbari@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar Aazam University Complex, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
m.akbari@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
MSc Student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar Aazam University Complex, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
m.akbari@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available