Determining the effect of using deep cough technique, and the technique of pressing the tip of the nose on pain intensity of urinary catheterization
Design
The present study is a randomized clinical trial with a control group without blinding that will be performed on 75 patients requiring urinary catheterization.
Settings and conduct
Sampling will be done in Imam Khomeini Educational, Research and Treatment Center. After obtaining the code of ethics from the university, we refer to the sampling place.
Patients who need urinary catheterization, both diagnostically and therapeutically, according to the relevant specialist, will be selected as a sample if they meet the inclusion criteria.
First, informed consent will be obtained from them and then their demographic information will be recorded. After entering the study, patients will be randomly divided into three groups: first intervention, second intervention and control group.
Participants/Inclusion and exclusion criteria
People 18-65 years old who need urinary catheterization
Intervention groups
The first intervention group: In the first group, patients are taught to do a deep cough before the catheter is inserted. Pause for 10 seconds and then do a second cough. The nurse inserts a urinary catheter into the urethra while the patient is coughing for a second time.
Second intervention group: In the second intervention group, patients are instructed to squeeze the tip of the nose and exhale and squeeze at the same time with the glottis closed. The nurse inserts the urinary catheter into the urethra at the same time.
Main outcome variables
Pain of catheterization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045764N3
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Ali Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3722 8634
Email address
abedia1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Coughing Technique (CT) and Nose Taking Technique (NTT) on Pain Intensity During Urinary Catheterization
Public title
Comparison the Effect of Coughing Technique (CT) and Nose Taking Technique (NTT) on Pain Intensity During Urinary Catheterization
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be a man
People 18-65 years old who need catheterization
No problem in feeling and understanding pain like nephropathies
The patient has the ability to cooperate in assessing pain (no mental disorders)
Exclusion criteria:
Catheterization should not be performed within the range of effects of narcotic and non-narcotic analgesics.
Hematuria
The patient has a history of heart disease
People with active urinary tract infections
Score above 39 mm Hg based on the VAS scale
Pre-existing urinary catheter
Urinary tract stenosis
Pre-existing urinary tract pain (for example: Patients with chronic pelvic pain syndromes, interstitial cystitis)
Neurological patients with decreased level of consciousness
anesthetized and intubated Patients
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation blocks were used for random allocation. Eligible patients were divided into three groups of first, second and control groups (Each group is 25 people).
Our 6-state blocks and how the different permutations should be, using random numbers on the back of Dr. Kazem Mohammad's book of statistics and with their eyes closed, first a number was determined and the different permutations of the 6-state blocks were recorded in sequence from left to right. So that if the number one came A, and the number 2 belonged to group B and the number 3 belonged to group C. And different modes of ABCABC, AABBCC, .... were identified for the Case 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
Ethics committee of Esfarayen University of Medical Sciences
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
۷۶۹۸١-۹۶۶١۸
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.ESFARAYENUMS.REC.1399.012
Health conditions studied
1
Description of health condition studied
The pain of urethral catheterization
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measuring the pain of urinary catheterization
Timepoint
Before, immediately and 15 minutes after urinary catheterization
Before, immediately after, and 15 minutes after the intervention
Method of measurement
Use of BC1000 Barometer cuff
2
Description
Pulse Rate (PR)
Timepoint
Before, immediately after, and 15 minutes after the intervention
Method of measurement
Check the pulse rate with the using of radial artery
3
Description
Respiration Rate (RR)
Timepoint
Before, immediately after, and 15 minutes after the intervention
Method of measurement
Check the patient's number of respiratory rate per minute
Intervention groups
1
Description
Intervention group: In the first group, patients are taught to first do a deep cough, pause for 10 seconds, and then do a second cough. The nurse inserts a urinary catheter into the urethra during the second cough.
Category
Other
2
Description
Intervention group: Patients in the second group are instructed to squeeze the tip of the nose and exhale compressively at the same time as the closed glottis, so that the nurse inserts the urinary catheter into the urethra to the end.
Category
Other
3
Description
Control group: In the control group, urinary tract catheterization is performed routinely.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Imam Khomeini Hospital
Full name of responsible person
Javad sedaghati
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
7698-9668
Phone
+98 58 3722 8757
Email
Info@esfrums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Neshat
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
7698-9668
Phone
+98 58 3722 8757
Email
Info@esfrums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Faculty member, instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
7698-9668
Phone
+98 58 3722 8757
Email
Info@esfrums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Educator, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
7698-9668
Phone
+98 58 3722 7857
Email
Info@esfrums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Faculty member, instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
7698-9668
Phone
+98 58 3722 8757
Email
Info@esfrums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD