The effect of non-pharmacological relaxation instructions on pain intensity, restlessness and delirium in mechanically ventilated patients after heart surgery
Design and validation of non-pharmacological relaxation instructions in patients undergoing mechanical ventilation after heart surgery
Determining the effect of relaxation instructions on the incidence of delirium, pain intensity and restlessness in mechanically ventilated patients after cardiac surgery
Design
A clinical trial with control groups, with parallel groups, one-sided, randomized, will be performed on 60 patients. Randomization will be performed using a table of random numbers and card selection by samples.
Settings and conduct
A clinical trial with the content of non-pharmacological relaxation instructions, which includes music therapy reorientation and family presence, will be performed on patients who are admitted to Shahid Chamran Hospital in Isfahan for elective open heart surgery and are eligible for the study. Blinding in this study will be done only for the samples under study.
Participants/Inclusion and exclusion criteria
Perform elective open heart surgery
Intervention groups
Up to 5 hours after the patient enters the ICU-OH while the patient is under mechanical ventilation, first the reorientation message will be retrieved by the researcher based on the 5wh and 1h methods, then the music with the title of white sound taken from the sounds of nature for 30 minutes will be broadcast for the patient through headphones. After the end of the music, the patient who has received the necessary training will be present at the patient's bedside for a maximum of 30 minutes, and after the end of the intervention, the evaluations will be performed using the predicted tools.
Main outcome variables
Pain Intensity; agitation; delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130218012509N6
Registration date:2021-08-13, 1400/05/22
Registration timing:retrospective
Last update:2021-08-13, 1400/05/22
Update count:0
Registration date
2021-08-13, 1400/05/22
Registrant information
Name
Batool Nehrir
Name of organization / entity
Baqyatallah Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 21222899413
Email address
rnehrir1739@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-pharmacological relaxation instructions on pain intensity, restlessness and delirium in mechanically ventilated patients after heart surgery
Public title
The effect of non-pharmacological relaxation instructions on pain intensity, restlessness and delirium in mechanically ventilated patients after heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ejection fraction at least 35%
Surgery elective
Lack of severe drug and alcohol addiction
No delirium or impaired level of consciousness before surgery
No severe visual or hearing impairment (blindness and deafness)
Availability of first-degree family members or causal and relative relatives (at the patient's discretion) who wish to participate in the study
Exclusion criteria:
Need for long-term mechanical ventilation as directed by your doctor
Need for sedation according to the doctor according to the treatment process
Unpredictable events (severe bleeding, severe hemodynamic disturbance, stroke)
Death of research units during the study
Reluctance and consent of the patient or family to continue participating in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple way using a table of random numbers in such a way that the researcher first determines that all patients to whom the even number is assigned in group A (test) and those who become individual in group B (Control) are placed. Then close your eyes and put your finger on one of the digits in the table of random numbers and write down the house number and column number of the starting point. The direction of movement is predetermined and horizontally to the right, then It was at the top and then to the left of the table. Each even number is entered in the test group and the odd number is entered in the control group. Then all the numbers are placed in separate envelopes and all are placed in a box. When the sample with the entry conditions and easily entered the study, then the card removed from the box by the sample is opened for him and Depending on whether it has the letter A or B, the sample is placed in one of two test or control groups. In this way, sampling continues until reaching the specified sample size Found.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding will be performed for patients participating in the trial
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqyatallah Medical Science University
Street address
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
81746-73461
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.051
Health conditions studied
1
Description of health condition studied
Ischemic heart disease
ICD-10 code
I25.0
ICD-10 code description
Ischemic heart disease
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before and after interventions
Method of measurement
Visual Analogue Scale
2
Description
Agitation
Timepoint
Before and after interventions
Method of measurement
Richmond Agitation-Sedation Scale
3
Description
Delirium
Timepoint
Before and after interventions
Method of measurement
Confusion Assessment Method for the ICU(CAM-ICU)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for the intervention group, a protocol designed including: informing patients by making changes in the environment, music with the content of nature sounds and the presence of family members on the patient's bed will be used.
Category
Lifestyle
2
Description
Control group: Routine care will be provided for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Batul Nehrir
Street address
Salman Farsi St., Shahid Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 13 22104
Email
pirnagmodin1364@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
81746-73461
Phone
+98 21 8755 5576
Email
pirnagmodin1364@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Batul Nehrir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
7346181746
Phone
+98 21 8755 5576
Email
pirnagmodin1364@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Batul Nehrir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
7346181746
Phone
0217555576
Email
rnehrir1739@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Batul Nehrir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Baha'i St. South - Baqiyatallah University of Medical Sciencesخیابان
City
Tehran
Province
Tehran
Postal code
7346181746
Phone
+98 21 8755 5576
Email
rnehrir1739@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data obtained from the study can be published after identifying the participants in the study
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data from this study will be available to researchers working in scientific and academic institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Contact email b.nehrir @bmsu.ac.ir
What processes are involved for a request to access data/document