Study the effect of family presence on patient’s pain and anxiety during invasive nursing procedures at the emergency department.
Design
Non-randomized clinical trial whit control group
Sample size is 70 person
Settings and conduct
This study will perform in an emergency department. Will carry out an invasive nursing procedure for experimental group in presence of family and for control group without family presence. Then mean pain and anxiety score before and after the invasive nursing procedure will compare between experimental and control group
Participants/Inclusion and exclusion criteria
inclusion criteria: Being 18-75 years old, Being open to communication and cooperation, Undergoing an invasive nursing procedure
.exclusion criteria: Without visitor
Having anxiety and psychological disorders
Using of sedative and hypnotic drugs
Drug addiction
Having severe pain
Taking pain killer
Intervention groups
Intervention group: The invasive nursing procedure (including: peripheral intravenous cannulation, intramuscular injection or venipuncture) will be performed whit family member presence (who is chosen by the patient). The type of invasive nursing procedures and relationship accompanying person with the patient will be written in the demographic and medical information form.
Control group: The invasive nursing procedure will be performed without family presence. In other words, family members Will be taken out by researcher before invasive nursing procedure.
Main outcome variables
Pain and anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039190N1
Registration date:2018-05-27, 1397/03/06
Registration timing:prospective
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Parvin Abdi gheshlaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4832 5867
Email address
parvinabdinurse1721369@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
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
Study the Effect of Family Presence on Patient’s Pain and Anxiety during Invasive Nursing Procedures at the Emergency Department
Public title
Study the Effect of Family Presence on Patient’s Pain and Anxiety during Invasive Nursing Procedures at the Emergency Department
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 18-65 years old
Being open to communication and cooperation
Undergoing an invasive nursing procedure
Exclusion criteria:
Without visitor
Having anxiety and psychological disorders
Using of sedative and hypnotic drugs
Drug addiction
Having severe pain
Taking pain killer
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not 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
Ethics committee of Shahid Beheshti university of medical sciences
Street address
Vali Asr Ave., Niayesh Complex., nursing shoole of Shahid Beheshti university of Medical Sciences.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.SBMU.PHNM.1396.964
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Pain score according to Visual Analogue Scale
Timepoint
After the invasive nursing procedure
Method of measurement
Visual Analogue Scale
2
Description
State anxiety score according to Spielberger anxiety inventory
Timepoint
Before and after the invasive nursing procedure
Method of measurement
Spielberger anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The invasive nursing procedure (including: peripheral intravenous cannulation, intramuscular injection or venipuncture) will be performed whit family member presence (who is chosen by the patient). The type of invasive nursing procedures and relationship accompanying person with the patient will be written in the demographic and medical information form.
Category
Other
2
Description
Control group: The invasive nursing procedure will be performed whitout family presence. In other words, family members Will be taken out by researcher before invasive nursing procedure.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Moaven hospital in Sahneh
Full name of responsible person
Ziba Barzabadi Farahani
Street address
Vali Asr Ave., Niayesh Complex., Nursing shoole of Shahid Beheshti university of medical sciences.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2511
Email
zibafarahani717@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziaei
Street address
Shahid Beheshti university of medical sciences, next to the Taleghani hospital, Shahid Arabi street, Yemen street, Shahid Chamran high way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvin Abdi Gheshlaghi
Position
Master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vali Asr Ave., Niayesh Complex., Nursing shoole of Shahid Beheshti university of medical sciences.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 83 4832 5867
Email
parvinabdinurse1721369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ziba Barzabadi Farahani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali Asr Ave., Niayesh Complex., Nursing shoole of Shahid Beheshti university of medical sciences.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2511
Email
zibafarahani717@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvin Abdi Gheshlaghi
Position
Master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vali Asr Ave., Niayesh Complex., Nursing shoole of Shahid Beheshti university of medical sciences.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 83 4832 5867
Email
parvinabdinurse1721369@gmail.com
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