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IRCT20120109008665N16 IRCT 2024-03-14 Semnan University of Medical Sciences Comparative study of Valsalva maneuver and Rhythmic breathing on pain intensity due to fistula cannulation Comparison of Valsalva maneuver and Rhythmic breathing in terms of their effectiveness on the pain of vascular needles insertion in hemodialysis patients 2024-04-08 anticipated 90 Complete https://irct.ir/trial/75931 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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. N/A Acute pain. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 353138111 +98 23 3365 4190 babamohammdy2007@gmail.com Semnan University of Medical Sciences scientific Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 babamohammdy2007@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 G89.18 Other acute postprocedural pain Treatment - Other Treatment - Other N/A 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. 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. 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. The severity of the pain. Timepoint: The first stage without intervention - the second stage after the intervention. Method of measurement: Numerical Pain Rating Scale. Semnan University of Medical Sciences Approved 2024-02-10 Semnan University of Medical Sciences Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)