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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Protocol summary
A double-blind, 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.
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.
A double-blindAn 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.
کارآزمایی بالینی دو سویه کور، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار تحت همودیالیز با استفاده از پاکت‌های مهر و موم شده حاوی حروف A، B و C به تعداد مساوی که حرف A معرف مانور والسالوا، B معرف تنفس ریتمیک، و C معرف گروه کنترل می‌باشد.
کارآزمایی بالینی بدون کورسازی، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار تحت همودیالیز با استفاده از پاکت‌های مهر و موم شده حاوی حروف A، B و C به تعداد مساوی که حرف A معرف مانور والسالوا، B معرف تنفس ریتمیک، و C معرف گروه کنترل می‌باشد.
کارآزمایی بالینی دو سویه کوربدون کورسازی، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار تحت همودیالیز با استفاده از پاکت‌های مهر و موم شده حاوی حروف A، B و C به تعداد مساوی که حرف A معرف مانور والسالوا، B معرف تنفس ریتمیک، و C معرف گروه کنترل می‌باشد.
General information
Double blinded
Not blinded
doublnotbl
1
1
1
1
1
1
empty
90
90
empty
2024-04-08, 1403/01/20
2024-04-08 00:00:00
empty
2024-10-21, 1403/07/30
2024-10-21 00:00:00
empty
2024-11-05, 1403/08/15
2024-11-05 00:00:00
empty
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.
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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به دلیل اینکه در این مطالعه امکان کورسازی وجود نداشت و بیماران گروه مانور والسالوا و تنفس ریتمیک و کنترل به وضوح از نوع مداخله آگاه بودند لذا تغییر کورسازی از حالت دوسو کور به حالت بدون کورسازی صورت گرفت.
به دلیل اینکه در این مطالعه امکان کورسازی وجود نداشت و بیماران گروه مانور والسالوا و تنفس ریتمیک و کنترل به وضوح از نوع مداخله آگاه بودند لذا تغییر کورسازی از حالت دوسو کور به حالت بدون کورسازی صورت گرفت.
Participants are randomly assigned to groups using sealed envelopes containing letters A, B, and C, each identifies the intervention or control groups. The outcome assessor, and the data analyst are unaware of the allocation of individuals to intervention and control groups.
Participants are randomly assigned to groups using sealed envelopes containing letters A, B, and C, each identifies the intervention or control groups. The outcome assessor, and the data analyst are unaware of the allocation of individuals to intervention and control groups.
شرکت کنندگان با استفاده از پاکت های مهر و موم شده حاوی حروف A، B و C که هر کدام مشخص کننده گروه های مداخله یا کنترل می باشند به صورت تصادفی به گروهها اختصاص می یابند، ارزیابی کننده پیامد و فرد تجزیه و تحلیل کننده داده های مطالعه از اختصاص افراد به گروه های مداخله و کنترل بی اطلاع می باشند.
شرکت کنندگان با استفاده از پاکت های مهر و موم شده حاوی حروف A، B و C که هر کدام مشخص کننده گروه های مداخله یا کنترل می باشند به صورت تصادفی به گروهها اختصاص می یابند، ارزیابی کننده پیامد و فرد تجزیه و تحلیل کننده داده های مطالعه از اختصاص افراد به گروه های مداخله و کنترل بی اطلاع می باشند.
Primary outcomes
#1
Visual Analogue Scale
Numerical Pain Rating Scale
Visual AnalogueNumerical Pain Rating Scale
مقیاس بصری سنجش درد
مقیاس عددی اندازه‌گیری درد
مقیاس بصری سنجشعددی اندازه‌گیری درد
Recruitment centers
#1
Name of recruitment center - English: Kowsar hospital affiliated to Semnan University of Medical Sciences
Name of recruitment center - Persian: بیمارستان کوثر وابسته به دانشگاه علوم پزشکی سمنان
Full name of responsible person - English: Hassan Babamohamadi
Full name of responsible person - Persian: حسن بابامحمدی
Street address - English: Kowsar Hospital; Amin Blv; Golestan town; Semnan
Street address - Persian: سمنان- شهرک گلستان- بلوار امین- بیمارستان کوثر
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3519899951
Phone: +98 23 3104 3209
Fax: +98 23 3343 7837
Email: kowsarhospital@semums.ac.ir
Web page address: http://kosarhos.semums.ac.ir
Name of recruitment center - English: Kowsar hospital affiliated to Semnan University of Medical Sciences
Name of recruitment center - Persian: بیمارستان کوثر وابسته به دانشگاه علوم پزشکی سمنان
Full name of responsible person - English: Hassan Babamohamadi
Full name of responsible person - Persian: حسن بابامحمدی
Street address - English: Kowsar Hospital, Amin Blv, Golestan town, Semnan
Street address - Persian: سمنان، شهرک گلستان، بلوار امین، بیمارستان کوثر
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3519899951
Phone: +98 23 3104 3209
Fax: +98 23 3343 7837
Email: kowsarhospital@semums.ac.ir
Web page address: http://kosarhos.semums.ac.ir
Name of recruitment center - English: Kowsar hospital affiliated to Semnan University of Medical Sciences Name of recruitment center - Persian: بیمارستان کوثر وابسته به دانشگاه علوم پزشکی سمنان Full name of responsible person - English: Hassan Babamohamadi Full name of responsible person - Persian: حسن بابامحمدی Street address - English: Kowsar Hospital;, Amin Blv;, Golestan town;, Semnan Street address - Persian: سمنان-، شهرک گلستان-، بلوار امین-، بیمارستان کوثر City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3519899951 Phone: +98 23 3104 3209 Fax: +98 23 3343 7837 Email: kowsarhospital@semums.ac.ir Web page address: http://kosarhos.semums.ac.ir
Protocol summary
Study aim
This study aimed to compare the effect of Valsalva maneuver and Rhythmic breathing on the severity of pain caused by fistula cannulation.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
The study will be performed on two groups of interventions, including Valsalva maneuver or Rhythmic breathing, and one control group, without any specific intervention.
Main outcome variables
Pain severity due to fistula cannulation
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2024-03-14, 1402/12/24
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
2024-04-08, 1403/01/20
Actual recruitment end date
2024-10-21, 1403/07/30
Trial completion date
2024-11-05, 1403/08/15
Scientific title
Comparison of Valsalva maneuver and Rhythmic breathing in terms of their effectiveness on the pain of vascular needles insertion in hemodialysis patients
Public title
Comparative study of Valsalva maneuver and Rhythmic breathing on pain intensity due to fistula cannulation
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
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.
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
Semnan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
IR.SEMUMS.REC.1402.276
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
The severity of the pain
Timepoint
The first stage without intervention - the second stage after the intervention
Method of measurement
Numerical Pain Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
3
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital affiliated to Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Street address
Kowsar Hospital, Amin Blv, Golestan town, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3104 3209
Fax
+98 23 3343 7837
Email
kowsarhospital@semums.ac.ir
Web page address
http://kosarhos.semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
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
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
353138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
babamohammdy2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
babamohammdy2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
babamohammdy2007@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
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available