The aim of this study will be to determine the effect of guided imagery and progressive muscle relaxation on sedation of noninvasive mechanically ventilated patients admitted to covid 19 intensive care unit.
Design
A clinical trial with a parallel-group, without blinding, will be performed on 80 patients with Covid 19 under non-invasive mechanical ventilation admitted to the intensive care unit. The samples will be divided into two interventional (n = 40) and control groups (n = 40) by simple randomization.
Settings and conduct
study will be performed on patients under non-invasive mechanical ventilation admitted in intensive care unit of Modares Hospital.
Participants/Inclusion and exclusion criteria
Patients with consciousness 15 according to Glasgow coma scale;
Patients aged 18 to 70 years old;
Patients admitted to the covid 19 intensive care unit for at least three days;
Patients undergoing oxygen therapy through non-invasive mechanical ventilation for at least three days;
Patients with no previous history of non-invasive mechanical ventilation;
Patients with no visual or hearing problems;
Patients with no movement disorders and paralysis;
Patients with no psychological disorders and taking sedatives before hospitalization.
Intervention groups
In the control group, patients will receive routine sedative care in the form of sedative drugs prescribed by a physician. In the intervention group, guided imagery and progressive muscle relaxation sessions will be held as a non-pharmacological treatment for each patient individually.
Main outcome variables
Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170617034592N2
Registration date:2022-03-02, 1400/12/11
Registration timing:prospective
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Atefe Salimi Akin Abadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4474 1308
Email address
atefe-salimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of guided imagery and progressive muscle relaxation on sedation of non invasive mechanically ventilated patients
Public title
Guided imagery and progressive muscle relaxation on sedation of non invasive mechanically ventilated patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with consciousness 15 according to Glasgow coma scale
Patients aged 18 to 70 years old
Patients admitted to the corona intensive care unit for at least 3 days
Patients undergoing oxygen therapy through non-invasive mechanical ventilation for at least 3 days
Exclusion criteria:
Patients with a history of non-invasive mechanical ventilation prior to hospitalization
Patients with visual and auditory problems
Patients with movement disorders and paralysis
Psychiatric patient and taking sedatives before hospitalization
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling method will be used for sampling. Then, patients with Covid 19 will be placed under non-invasive mechanical ventilation in the intensive care unit with inclusion criteria, alternately using a simple random method in the interventional and control 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
Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Street address
Arabi Ave, Bldg No.2 SBUMS, 7th Floor, Velenjak, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.1026
Health conditions studied
1
Description of health condition studied
Covid-19 patients
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
sedation
Timepoint
In the intervention group before of the intervention and after the intervention / in the control group at the beginning of the study and one week after the initial completion of the questionnaire
Method of measurement
Adaptation to the intensive care environment (ATICE), new sedation assessment instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before performing the intervention, after explaining the objectives of the study, informed consent will be obtained from the patients of the intervention group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. The intervention will be performed on patients in this group. Prior to the intervention, demographic questionnaires, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed. In this group, in addition to routine care, the intervention will be an explanation of the goals of guided imagery and progressive muscle relaxation , an explanation of the positive effects and usefulness of this method, based on the article by Ghaffari et al. (2007), guided imagery and progressive muscle relaxation as a non-pharmacological treatment will be held individually for 4 days a week for 30 minutes every other day. The researcher will be present at each patient's bedside and will teach guided imagery and progressive muscle relaxation techniques. In this way, in the evening shift, when the ward is quieter and environmental stimuli such as noise and commuting caused by visits are less, he is present in the intensive care unit and is present at each patient's bedside and tells the patient about guided imagery and progressive muscle relaxation. guided imagery and progressive muscle relaxation are often used together because visualization can enhance the relaxation process and enhance its effect. This method is one of the components of cognitive-behavioral therapy that is designed to reduce stress and anxiety through muscle relaxation. In the first session, regarding the goals and stages of the training program, theoretical foundations related to the guided imagery and progressive muscle relaxation technique, introducing muscles and muscle groups, training on how and steps to perform the relaxation technique along with guided imaging and the time of relaxation technique. Will be trained. During the second to fourth sessions to start the exercises, for physical relaxation, the patient is asked to be in the supine position, after a few deep breaths of the abdomen and diaphragm with the eyes closed and comfortable, in the best position in which he feels relaxed. In the first 20 minutes of the session, relaxation exercises will be performed, during which the mind will focus on the contraction of the muscles of different parts of the body and then their rest. Relaxation exercises for 8 muscle groups including arm muscles, upper arm muscles, shoulder and neck muscles, back and shoulder muscles, facial muscles, chest muscles involved in the process of breathing exercises, abdominal muscles, muscles The first step is to consciously relieve tension on the muscles, and in the final 10 minutes of the session, guided imagery with a focus on depicting a desirable scene and custom (forest, beach, religious places, hospital discharge and presence with family, reducing the need for oxygen therapy and comfortable breathing ...) will be done. During the imaging, the patient will visualize a scene in which he feels safe and free from tension and anxiety, and with the voice of the researcher, the imaging is done for the patient and the patient enters a pleasant atmosphere that is his favorite. In general, people are encouraged to take deep abdominal and diaphragmatic breaths and then combine muscle release with depictions of landscapes such as forests, the beach, or places of pilgrimage. Progressive muscle relaxation and visualization are often used together because visualization can enhance the relaxation process and increase its effectiveness. The patient will perform sedation technique under the supervision of the researcher and feedback will be taken from the patient after each session. Before the start of each session, the researcher will answer patients' possible questions about the relaxation technique and feedback on the positive experiences of the previous session. Patients' physiological criteria will also be recorded before and after each relaxation session. At the end of the session, patients are asked to write down the number of times they do relaxation exercises and guided imagery. Finally, after the end of the fourth session, the information of this group will be collected using questionnaires and will be analyzed according to the goals of the study.
Category
Other
2
Description
Control group: informed consent will be obtained from the patients of the control group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. Questionnaires of demographic characteristics, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed in patients in the control group. In this group, patients will receive only routine sedation care in the form of sedatives prescribed by a physician. After a week, the information of the control group will be collected using questionnaires and will be analyzed according to the goals of the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Dr Saeed Alipour Parsa
Street address
Shahid Modarres hospital, Saadatabad intersection , Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Sciences Vice-Chancellor of Research Affair
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
Atefe Salimi Akin Abadi
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Modarres hospital,Saadatabad intersection, Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
atefe-salimi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefe Salimi Akin Abadi
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Modarres hospital, Saadatabad intersection , Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
atefe-salimi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefe Salimi Akin Abadi
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Modarres hospital, Saadatabad intersection, Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
atefe-salimi@sbmu.ac.ir
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
Not applicable
Title and more details about the data/document
The data obtained from the study will be published in the form of research project report and article without mentioning the names of the participants.
When the data will become available and for how long
The access period will start 6 months after the publication of the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There will be access to data to compare the results of the study in similar trials.
From where data/document is obtainable
phone:09199135395
email:atefe.salimi@yahoo.com
What processes are involved for a request to access data/document
In the articles resulting from the study, the e-mail of the responsible author and other authors will be included, and through this, researchers can communicate with the authors and submit their request, which will be answered in the shortest possible time.