Protocol summary
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Study aim
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This study aimed to compare the effect of Valsalva maneuver and Rhythmic breathing on the severity of pain caused by fistula cannulation.
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Design
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An unblinded , controlled, parallel-group, randomized clinical trial on 90 hemodialysis patients using sealed envelopes containing the letters A, B and C in equal numbers, where A represents Valsalva maneuver, B represents Rhythmic breathing, and C represents the control group.
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Settings and conduct
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This study will be conducted in the hemodialysis department of Kawsar Semnan Hospital. In the Valsalva maneuver group, after blowing into a plastic tube connected to a mercury pressure gauge, perform the Valsalva maneuver for at least 20 seconds, and then fistula cannulation will be performed. In the second group, first the patient closes his eyes, lies on his back and inhales through the nose by counting the numbers from 1 to 3, then holds his breath by counting the numbers 1 to 3 again and counting the numbers Exhales 1 to 3 through the mouth. This work will be done for 20 minutes, every 5 minutes and each time for 1 minute. Fistula cannulation will be performed in the same conditions as the first group. No special action will be taken in the control group and fistula cannulation will be done in the same way as the previous two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: hemodialysis started at least 3 months ago; no addiction and dependence on painkillers; no pain before cannulation; no use of sedatives in the last 24 hours; no wound in the fistula area. Exclusion criteria: unsuccessful cannulation in the first step and repeated insertion of the needle into the skin.
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Intervention groups
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The study will be performed on two groups of interventions, including Valsalva maneuver or Rhythmic breathing, and one control group, without any specific intervention.
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Main outcome variables
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Pain severity due to fistula cannulation
General information
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Reason for update
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Because blinding was not possible in this study and patients in the Valsalva maneuver, rhythmic breathing, and control groups were clearly aware of the type of intervention, blinding was changed from double-blind to unblinded.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120109008665N16
Registration date:
2024-03-14, 1402/12/24
Registration timing:
prospective
Last update:
2025-04-08, 1404/01/19
Update count:
1
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Registration date
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2024-03-14, 1402/12/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-08, 1403/01/20
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Expected recruitment end date
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2024-08-20, 1403/05/30
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Actual recruitment start date
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2024-04-08, 1403/01/20
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Actual recruitment end date
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2024-10-21, 1403/07/30
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Trial completion date
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2024-11-05, 1403/08/15
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Scientific title
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Comparison of Valsalva maneuver and Rhythmic breathing in terms of their effectiveness on the pain of vascular needles insertion in hemodialysis patients
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Public title
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Comparative study of Valsalva maneuver and Rhythmic breathing on pain intensity due to fistula cannulation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 18 years
History of at least 3 months of hemodialysis
No addiction or dependence on painkillers
No pain before cannulation
Do not use the sedative at the last 24 hours
No wounds in the fistula area
Not treated with sulfonamides, nitrates and phenobarbital
Not having a pacemaker
No history of Alzheimer's disease, dementia, peripheral vascular disease, diabetic neuropathy, liver disease
Lack of respiratory problems, brain problems, glaucoma, increased intracranial pressure and recent eye surgery
Exclusion criteria:
Patients who are unable to perform the Valsalva maneuver by holding the mercury column above 20 mm Hg for 20 seconds
Unsuccessful cannulation in the first step and repeated insertion of the needle into the skin
Patients with known heart attack or those with hemodynamic problems or dangerous arrhythmias
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned to three groups using the random blocks method and by 90 sealed envelopes containing one of the letters A, B and C in an equal number (30 envelopes of each letter) where A represents Valsalva maneuver, B represents rhythmic breathing and C represents the control group. Patients will select the envelope themselves.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-10, 1402/11/21
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Ethics committee reference number
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IR.SEMUMS.REC.1402.276
Health conditions studied
1
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Description of health condition studied
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Acute pain
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ICD-10 code
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G89.18
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ICD-10 code description
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Other acute postprocedural pain
Primary outcomes
1
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Description
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The severity of the pain
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Timepoint
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The first stage without intervention - the second stage after the intervention
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Method of measurement
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Numerical Pain Rating Scale
Intervention groups
1
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Description
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Intervention group: Valsalva maneuver in the first group was accomplished through blowing in a plastic pipe connected to a mercury barometer (Easylife, china) and holding up mercury bar upper than 20 mmHg for at least 20 seconds. After the place was disinfected using cotton drained in alcohol. Then, BP16 IVC was used to do fistula cannulation while the patient lay back and his head is against the cannulation point.
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Category
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Treatment - Other
2
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Description
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Intervention group: Patients of the second group (rhythmic breathing) in order to perform the intervention, first the patient closes his eyes, lies on his back and breathes through the nose by counting the numbers from 1 to 3, Then he/she held his/her breath by counting the numbers 1 to 3 again. He/she locks himself/herself and exhales through the mouth by counting the numbers 1 to 3. This work will be done for 20 minutes, every 5 minutes and each time for 1 minute. Fistula cannulation will be performed under the same conditions as the first group.
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Category
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Treatment - Other
3
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Description
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Control group: In the third group (control), there will be no special intervention. Fistula cannulation will be performed under the same conditions of the two intervention groups.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available