"The effects of diaphragmatic and resonance breathing techniques on physiological indices and pain intensity during arteriovenous fistula cannulation in hemodialysis patients”
-Pain intensity in 3 groups during cannulation
- Systolic and diastolic blood pressure, heart rate, and respiratory rate in 3 groups 0, 1, 5, and 10 minutes after the intervention
Design
Crossover clinical trial with 2 intervention groups and 1 control group - 135 patients - 6-block randomization
Settings and conduct
• Diaphragmatic breathing: Lie on your back on the bed for 5 minutes and place a pillow under your head and knees - Place one hand on your chest and the other on your stomach - Inhale through your nose and exhale through your mouth - Rest for 5 minutes
• Resonance breathing group: Place the patient in a semi-sitting position at a 45-degree angle, place one hand on your stomach and the other on your diaphragm - Take 5 deep breaths per minute using your diaphragm
• Control group: Receive routine hospital care
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Consciousness
2- Age over 18 years
3- Absence of neuropathic disorders and peripheral vascular diseases
4- Absence of respiratory diseases (COPD, asthma)
5- Successful cannulation in the first attempt
Exclusion criteria:
1- Development of respiratory problems during the study
2- Development of a critical life-threatening condition during the study
3- Death of the patient, change in the treatment process such as transplantation
Intervention groups
- Diaphragmatic breathing group
- Resonance breathing group
- Control group
"The effects of diaphragmatic and resonance breathing techniques on physiological indices and pain intensity during arteriovenous fistula cannulation in hemodialysis patients”
Public title
"The effect of diaphragmatic and resonance breathing techniques on arteriovenous fistula in hemodialysis patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of hemodialysis through a fistula for at least three months, at least twice a week
Being conscious
Age 18 to 75 years
No problems in accessing the vessels and no neuropathic disorders and peripheral vascular diseases
No respiratory diseases (COPD, asthma, etc.)
Exclusion criteria:
Life-threatening critical condition
Unsuccessful cannulation on the first attempt
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done on a convenience basis, but the allocation of diaphragmatic breathing, resonant breathing, and cannulation control will be done using a 6-block randomization method as ABC-ACB-BCA-BAC-CAB-CBA. In this way, a sequence of the above blocks will be randomly generated using R software, and a list will be created, and patients will be randomly assigned to one of the three groups based on the aforementioned list.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a single-blind study.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Ghaem Square, Shahid Fahmideh Street,Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838741
Approval date
2025-07-26, 1404/05/04
Ethics committee reference number
IR.UMSHA.REC.1404.312
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
Z49.02
ICD-10 code description
Encounter for fitting and adjustment of peritoneal dialysis catheter
Primary outcomes
1
Description
The amount of pain felt by the patient is determined using the Numeric Rating Scale scale on a scale from 0 to 10.
Timepoint
The intensity of patients' pain during the insertion of arterial and venous needles (in the two stages of cannulation) will be measured by an experienced dialysis nurse for all groups.
Method of measurement
Assessment of patient pain from two cannulation lines using the Numeric Rating Scale by a nurse who is unaware of the study groups.
2
Description
Oxygen saturation percentage measured with a pulse oximeter.
Timepoint
The measurement is performed in such a way that after the patient lies down on the bed and rests for 3 minutes, the oxygen saturation percentage will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
3
Description
Systolic blood pressure is the blood pressure during the contraction phase of the heart, which is recorded as a number in millimeters of mercury based on the monitoring device.
Timepoint
The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, systolic blood pressure will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
4
Description
Diastolic blood pressure is the blood pressure during the resting phase of the heart, which is recorded as a number and in millimeters of mercury based on the monitoring device.
Timepoint
The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the diastolic blood pressure will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
5
Description
Mean atrial pressure= + (2 × diastolic pressure)] (systolic pressure)] / 3which is recorded as a number based on the monitoring device.
Timepoint
The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the Mean atrial pressure pressure will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
6
Description
The number of heartbeats per minute, which is monitored and recorded by a vital signs monitoring device.
Timepoint
The measurement is performed in such a way that after the patient lies down on the bed and rests for 3 minutes, the number of heart beats per minute will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
7
Description
The number of breaths per minute, which is monitored and recorded by a vital signs monitoring device.
Timepoint
The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the number of breaths per minute will be measured.
Method of measurement
Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups.
Secondary outcomes
1
Description
Pain score
Timepoint
During cannulation
Method of measurement
Numeric Rating Scale
2
Description
Mean systolic and diastolic blood pressure
Timepoint
0, 1, 5 and 10 minutes after intervention
Method of measurement
Vital signs monitoring device
3
Description
Pulse and respiration rate
Timepoint
0, 1, 5 and 10 minutes after intervention
Method of measurement
Vital signs monitoring device
Intervention groups
1
Description
Intervention group 1: Diaphragmatic breathing technique for 5 minutes during three hemodialysis sessions
Category
Treatment - Other
2
Description
Intervention group 2: Resonance breathing technique for 5 minutes during three hemodialysis sessions.
Category
Treatment - Other
3
Description
Control group: Control group: Routine hospital care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti medical center, Hamadan
Full name of responsible person
Amir hossein Asadi
Street address
Ghaem Square _ Beginning of Eram Boulevard Shahid Beheshti Specialized and Subspecialized Medical Training Center- HAMADAN
City
Hamadan
Province
Hamadan
Postal code
6517837741
Phone
+98 81 3838 0704
Email
Amirasadi1977@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 4047
Fax
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Hossein Asadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1014
Email
Amirasadi1977@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezou Karampourian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1014
Email
karampor1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Para medicine, Department of Operating Room, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1017
Email
behzadiman@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available