Determining the effect of using eye mask and ear plugs on the PTSD risk level in bedridden patients in open heart surgery care unit
Design
The present research is a clinical trial study with control group with parallel and randomize groups design of 68 patients and outcome assessment
Settings and conduct
The research environment of Shahid Rajaee Hospital in Alborz province, where open heart surgery is performed. After determining the sample size with easy sampling patients will be selected and then using the two red and white balls then patients will be divided randomly into two groups . patients under studying have an eye mask and ear plugs during the night time sleep (10 pm to 6 am), and the control group will be free of eye mask and ear plugs until the time of discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 - The patient has not history of mental illness.
2. the patient has not history of recent stress except heart surgery.
3. over 18 years old.
4. The patient has not mechanical ventilation.
5. The patient's heart surgery wil be emergency.
Exit criteria:
1. The patient does not want to cooperate.
2. Fear of wearing eye mask and ear plugs.
3. Have another operation after the first one .
Intervention groups
Patients who have entered the study, During night sleep (10 pm to 6 am), one group used eye mask and ear plugs, and the control group,will not use eye mask and ear plugs.
Main outcome variables
eye mask, ear plugs
General information
Reason for update
Acronym
ptsd
IRCT registration information
IRCT registration number:IRCT20180803040683N1
Registration date:2018-08-05, 1397/05/14
Registration timing:prospective
Last update:2018-08-05, 1397/05/14
Update count:0
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Zohreh Froughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
z.froughi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effects of using eye mask and ear plugs on the PTSD risk level in post heart surgery in ICU patients
Public title
Study on the effects of using eye mask and ear plugs on the PTSD risk level in post heart surgery in ICU patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has not history of mental illness.
The patient's heart surgery will be emergency.
Exclusion criteria:
The patient does not want to cooperate.
Have another surgical operation after the first operation.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected by simple sampling method and then,by using two red and white balls, patients will be randomly divided to two 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 Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.Qms.Rec.1396.70
Health conditions studied
1
Description of health condition studied
ptsd-in open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Risk rate mark in the IES-R questionnaire
Timepoint
Measuring the risk of post traumatic stress two months after intervention
Method of measurement
IES-R questionnaire
Secondary outcomes
1
Description
Risk rate mark in the IES-R questionnaire
Timepoint
Two months after the intervention
Method of measurement
IES-R questionnaire
Intervention groups
1
Description
Before and the first day of surgery, , give the patient an eye mask and two ear plugs and training the procedure of using them . At night, before sleeping time mention the procedure of using instruments that we said above
Category
Prevention
2
Description
Control group:During the night time sleep, the patient does not use the eye mask and ear plugs
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid rajaee hospital
Full name of responsible person
Froughi Zohreh
Street address
Shahid beheshti Ave, Shahid rajaee hospital
City
Alborz
Province
Alborz
Postal code
3419759811
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
Z.froughi@gmail.com
Web page address
https://rajaei.abzums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. peymani, Amir
Street address
Shahid Bahonar Blvd, Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Froughi, Zohreh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Blvd, Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Z.froughi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Froughi, Zohreh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Blvd, Ghazvin University of Medical Sciences Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Z.froughi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Froughi,Zohreh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Blvd, Ghazvin University of Medical Sciences Qazvin Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Z.froughi@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