The Effect of Guided visualization on Calming and Improving the Blood Oxygen Level of Chronic Obstructive Pulmonary Disease Patients Under Non-invasive Mechanical Ventilation
Reducing the anxiety of COPD patients under ventilation with a non-invasive mask and improving physiological conditions
Design
A semi-experimental study using Altman's nomogram, the required sample size is 27 people in each group, and considering a ten percent sample drop, 70 people are selected in each group, and then coding is done from number 1 to 70, and sixty are selected by lottery. People are chosen from among them
Settings and conduct
Sampling location of all ICUs of Baqiyatollah Hospital in Tehran; all patients with non-invasive ventilation conditions; audio file is played for a minute for patients while wearing a mask, and physiological conditions and anxiety are controlled. The same routine is performed for control patients..
Participants/Inclusion and exclusion criteria
Having COPD requires high pressure oxygen therapy
Patients with mechanical ventilation with a non-invasive mask
Age between 15 and 65 years
Having healthy hearing and full consciousness
Not having nervous and mental diseases
Not taking sedatives and sleeping pills
Intervention groups
A mask is established for the patient and mechanical ventilation is established. And after thirty minutes, blood oxygen levels and physiological conditions including; Heart rate, breathing rate and restlessness level of the patient according to RASS criteria; Then, for twenty minutes of relaxation with the help of an audio file and headphones, the same routine procedures are performed for the control group.
Main outcome variables
Reducing anxiety and improving the physiological conditions of patients under ventilation with a non-invasive method
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240103060598N1
Registration date:2024-04-04, 1403/01/16
Registration timing:registered_while_recruiting
Last update:2024-04-04, 1403/01/16
Update count:0
Registration date
2024-04-04, 1403/01/16
Registrant information
Name
javad jamalreza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 935 8173
Email address
javadjjamalreza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Guided visualization on Calming and Improving the Blood Oxygen Level of Chronic Obstructive Pulmonary Disease Patients Under Non-invasive Mechanical Ventilation
Public title
The Effect of Guided visualization on Calming and Improving the Blood Oxygen Level of Chronic Obstructive Pulmonary Disease Patients Under Non-invasive Mechanical Ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having COPD
Needs high pressure oxygen therapy-
Patients with mechanical ventilation with a non-invasive mask-
Age between 15 and 65 years old
Having healthy hearing and full consciousness
Not having nervous and mental diseases-
Not taking sedatives and sleeping pills
Exclusion criteria:
Invasive mechanical ventilation
Repentance or decreased level of consciousness of the patient during the study
Use of sedative drugs
Unwillingness to continue research
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Using Altman's nomogram, the required sample size of 27 people in each group was estimated, which was studied by considering ten percent dropout of 30 people in each group. The initial screening was done based on the entry and exit criteria, 70 people were selected and then from Numbers 1 to 70 are coded and sixty patients are selected by lottery and again these sixty patients are listed from number one to sixty using a table of random numbers.
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
Baqiyatullah-ul-Azam (A.J.) Medical Education Center (Ethics in Research Committee)
Street address
Tehran - Quds town (west) - between South Flamak and Zarafshan, Simai Iran St. - Central Headquarters of Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.084
Health conditions studied
1
Description of health condition studied
Congestive respiratory diseases
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Reducing the anxiety of patients undergoing non-invasive ventilation
Timepoint
Restlessness level control - physiological conditions when using a non-invasive mask before listening to the file and half an hour after listening to the file
Method of measurement
Use of rass criteria - pulse oximeter and pressure gauge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention group used an audio file with headphones based on Benson's relaxation technique for 30 minutes while using a non-invasive mask and repeated up to one hour if needed and controlling the level of anxiety with the rass criterion as well as controlling the physiological conditions such as heart rate, blood pressure of the patient before And after the audio file
Category
Other
2
Description
Control group: The control group uses a non-invasive mask alone, as per the department's protocol, and before and during the use of the mask, the blood oxygen level, vital signs and anxiety level of the patient will be controlled with rass criteria
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah Hospital, Tehran, ICU departments
Full name of responsible person
Javad Jamalreza
Street address
Tehran, Vanak Square, Molla Sadra St., Sheikh Bahai St., Baqiyatullah University