Determining the effect of Valsalva maneuver and distraction on pain intensity during vascular needle insertion in hemodialysis patients.
Design
A clinical trial with a control group, one-way blind, single-center trial, randomized, 30 participants in 3 groups of 10 people.
Settings and conduct
Hemodialysis Center of Imam Ali Karaj Hospital
Pain intensity when inserting arterial needles is measured in 3 modes (Valsalva maneuver, distraction, and routine care).
The participating person and the person who performs the statistical analysis do not know about the intervention modes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 and above; Performing hemodialysis through an arteriovenous fistula; At least three months have passed since the start of hemodialysis through the fistula
Exclusion Criteria: Injury or lesion in the hand with fistula; Patients who are unable to perform the Valsalva maneuver by keeping the mercury column higher than 20 mmHg for 20 seconds; Failure to take a vein from the person in the first attempt
Intervention groups
Intervention group 1: In this group (Valsalva maneuver), according to the protocol, the patient blew into a disposable plastic tube connected to a mercury sphygmomanometer, and keeps the mercury column up to 20 mm Hg for at least 15 seconds. after the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured.
Intervention group 2: In this group (thought deviation), according to the protocol, one minute before the intervention, the patient holds a soft pressure ball in his opposite hand and presses it by opening and closing his hand and starts counting, and it continues for one minute after entering the arterial needle.
Control group: No treatment is done and only routine treatment is done.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N81
Registration date:2024-01-17, 1402/10/27
Registration timing:prospective
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of valsalva maneuver and distraction on pain intensity during vascular needle insertion in hemodialysis patients
Public title
The effect of valsalva maneuver and distraction on pain intensity during vascular needle insertion in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Minimum literacy to recognize numbers
Performing hemodialysis through an arteriovenous fistula
At least three months have passed since the start of hemodialysis through the fistula
Absence of simultaneous pain in other parts of the body
Not receiving drugs and painkillers from 6 hours ago
Exclusion criteria:
Injury or lesion in the hand with fistula
Patients who are unable to perform the Valsalva maneuver by keeping the mercury column higher than 20 mmHg for 20 seconds.
Failure to take a vein from the person in the first attempt
The presence of phlebitis at the site of the fistula
Patients with a history of cardiovascular disease (bradycardia, hypotension, and CHB) and cerebrovascular disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 3).
Using Sealed Envelope software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
The participating person and the person who performs the statistical analysis do not know about the intervention modes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.SEMUMS.REC.1402.175
Health conditions studied
1
Description of health condition studied
Pain intensity
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain intensity
Timepoint
One minute after inserting the arterial needle and fixing it
Method of measurement
Numeric Pain Rating Scale (NRPS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group (Valsalva maneuver), according to the protocol, the patient blew into a disposable plastic tube connected to a mercury sphygmomanometer (Easy Life, TXJ-10B model, China). and keeps the mercury column up to 20 mm Hg for at least 15 seconds. after the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured.
Category
Treatment - Other
2
Description
Intervention group: In this group (thought deviation), according to the protocol, one minute before the intervention, the patient holds a soft pressure ball in his opposite hand and presses it by opening and closing his hand and starts counting, and it continues for one minute after entering the arterial needle.
Category
Treatment - Other
3
Description
Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Center of Imam Ali Karaj Hospital
Full name of responsible person
Mansour Azarian
Street address
Three ways azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
1418946846
Phone
+98 26 3256 2358
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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