Protocol summary

Study aim
Compare combination of rhythmic breathing with Hugo point acupressure versus vapocoolant spray in reducing pain during needle insertion.
Design
An experimental design will be conducted to compare Rhythmic Breathing combined with Hugo Point Acupressure versus vapocoolant spray in alleviating pain. A total of 120 participants will be included in the study, with 24 participants in each group.
Settings and conduct
In Dhi Qar Governorate, Iraq, covering several hemodialysis centers, including Al-Hussein Center, Souq Al-Shuyukh Dialysis Center. The study will involve over 500 male patients aged 18 years or older, aiming to assess both administrative needs and the accessibility of the research population.
Participants/Inclusion and exclusion criteria
Inclusion criteria :male hemodialysis patients aged 18+, with an arteriovenous fistula, alert, able to speak, not taking analgesics. Exclusion criteria:with unrelated severe pain, allergies to vapocoolant spray, recent surgery near the fistula, cognitive impairments, infections at the fistula site, or inflammation at the Hugo point.
Intervention groups
Rhythmic Breathing: Participants will practice deep breathing for two minutes before and during needle insertion, inhaling, holding, and exhaling for a count of three. Hugo Point Acupressure: The Hugo Point on the hand will be massaged with moderate pressure for two minutes before and during needle insertion, using a cycle of 10 seconds of pressure and 2 seconds of rest. Combination of Rhythmic Breathing and Acupressure: Both techniques will be applied together for two minutes before and during needle insertion. Vapocoolant Spray: The spray will be applied to the skin for 3-4 seconds, followed by a 10-second evaporation, before needle insertion.
Main outcome variables
Pain Intensity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241103063578N1
Registration date: 2024-11-23, 1403/09/03
Registration timing: prospective

Last update: 2024-11-23, 1403/09/03
Update count: 0
Registration date
2024-11-23, 1403/09/03
Registrant information
Name
Hassan Raysan Mohammed
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 780 628 6907
Email address
hasan.band2302m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rhythmic Breathing Integrated with Hugo Point Acupressure V.S. Vapocoolant Spray on Pain Intensity During Needle Insertion into Arteriovenous Fistula in Hemodialysis Patients:A Randomized Controlled Trial
Public title
Rhythmic Breathing Integrated with Hugo Point Acupressure V.S. Vapocoolant Spray on Pain Intensity During Needle Insertion into Arteriovenous Fistula in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The participants must be male individuals who are receiving regular hemodialysis treatment Alertness The individuals participating in this study are required to be a minimum of 18 years old or older Ability to speak The participants are required to possess an arteriovenous fistula that serves as the access point for dialysis. Participants who do not take analgesics Not having diabetes for over 10 years
Exclusion criteria:
Patients who are experiencing severe pain or discomfort that is not associated with the needle insertion procedure are to be excluded Patients who have documented allergies or hypersensitivity reactions to vapocoolant spray Patients who have undergone recent surgical procedures or have experienced trauma in proximity to the arteriovenous fistula are disqualified Patients exhibiting cognitive impairment or mental health disorders that may hinder their ability to comprehend instructions or provide informed consent Patients presenting with active infections or complications at the site of the arteriovenous fistula Inflammation or injury at the Hugo point .
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling methodology encompasses a dual-phase procedure designed to procure representative constituents of the target population, specifically male patients undergoing hemodialysis who are subjected to needle insertion into arteriovenous fistulas. In the initial phase, researcher will disseminate two distinct categories of cards: one denoting the patient's eligibility for participation in the study (orange), and the other signifying ineligibility (gray). Patients who are in possession of the eligible card will subsequently select from one of five colored cards , each representing a different study condition: White = Control group Yellow = Rhythmic breathing only Green = Hugo point acupressure only Blue = Vapocoolant spray only red = Rhythmic breathing integrated with Hugo point acupressure
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
Ethics committee in college of nursing at University of Baghdad
Street address
Bab-ALMuadham
City
Baghdad
Postal code
10053
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
5

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
R52
ICD-10 code description
Pain, unspecified

Primary outcomes

1

Description
Primary outcome variable is the level of pain, which can be altered based on the Hugo point acupressure, Rhythmic breathing, and vapocoolant spray.
Timepoint
Two minute before needle insertion and during insertion
Method of measurement
Visual analog scale (VAS) will be use to assess intensity of pain

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rhythmic Breathing: Participants will practice deep breathing for 2 minutes before needle insertion, inhaling, holding, and exhaling for 3 seconds each. The exercise continues during needle insertion.Hugo Point Acupressure: The non-inserted hand will receive circular massage on the Hugo point for 2 minutes before and during needle insertion, with pressure applied for 10 seconds followed by 2 seconds of rest.Rhythmic Breathing + Hugo Point Acupressure: Participants will combine both interventions, engaging in rhythmic breathing while receiving Hugo point acupressure for 2 minutes before and during needle insertion.Vapocoolant Spray: The spray will be applied to the skin for 3-4 seconds, followed by a 10-second evaporation period before needle insertion.Pain intensity will be evaluated immediately after needle insertion in all interventions.
Category
Other

2

Description
Control group: Control For the control group, no interventions will be done, and the pain will assess immediately after needle insertion in arteriovenus fistula
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Hussein Center for Dialysis
Full name of responsible person
Hassan Raysan Mohammad
Street address
Al-Nasiriyah
City
Al-Nasiriyah
Postal code
64001
Phone
+964 1 415 0076
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

2

Recruitment center
Name of recruitment center
Souq Al-Shuyukh Dialysis Center
Full name of responsible person
Hassan Raysan Mohammad
Street address
Souq Al-Shuyukh
City
Al-Nasiriyah
Postal code
64016
Phone
+964 1 415 0076
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

3

Recruitment center
Name of recruitment center
Imam Hassan Al-Mujtaba Hemodialysis Unit
Full name of responsible person
Hassan Raysan Mohammad
Street address
Karbala
City
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

4

Recruitment center
Name of recruitment center
Habib bin Mazahir Al-Asadi Hemodialysis Center
Full name of responsible person
Hassan Raysan Mohammad
Street address
Karbala
City
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Assistant Professor Wafaa Abdul Ali Hattab
Street address
Bab AL-Muadum Medical City Complex
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Hassan Raysan Mohammad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adults Nursing
Street address
Souq Al-Shuyukh
City
Al-Nasiriyah
Province
Dhi Qar
Postal code
64016
Phone
+964 1 521 1494
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://g.co/kgs/1AbtJ2H

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Hassan Raysan Mohammad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adults Nursing
Street address
Souq Al-Shuyukh
City
Al-Nasiriyah
Province
Dhi Qar
Postal code
64016
Phone
+964 1 521 1494
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://g.co/kgs/1AbtJ2H

Person responsible for updating data

Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Hassan Raysan Mohammad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adults Nursing
Street address
Souq Al-Shuyukh
City
Al-Nasiriyah
Province
Dhi Qar
Postal code
64016
Phone
+964 1 521 1494
Email
Hasan.band2302m@conursing.uobaghdad.edu.iq
Web page address
https://g.co/kgs/1AbtJ2H

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: Hasan.band2302m@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.
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