The comparative effect of acupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis referred to the clinical centers of Kerman University of Medical Sciences, in 2019
Determining the effect of acupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis referred to the clinical centers of Kerman University of Medical Sciences, in 2019
Design
A crossover randomized Clinical trial with two intervention groups without blinding. Samples will be randomly assigned into two blocks of 25 samples, 25 samples in acupressure/cryotherapy group and 25 samples in cryotherapy/acupressure group by Permuted Block Randomization.
Settings and conduct
All patients undergoing hemodialysis referring to health centers of Kerman University of Medical Sciences in 1398 will form the study population. Medical centers affiliated to Kerman University of Medical Sciences will be the research environment. In this study, all of the samples will have an acupressure session and a cryotherapy session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; Being conscious; the ability of verbal communication; 3 months passed the time of fistula embedding; At least 6 months passed the time of hemodialysis Initiation; Having an active medical document; In case of diabetes, controlled diabetes. Exclusion criteria: Receiving a sedative or opiate drug for 8 hours before hemodialysis; Excessive pain in other body parts; The presence of skin problem, insensibility, neuropathic disorders and peripheral vascular disease at the site of access to the vessels.
Intervention groups
Cryotherapy/Acupressure intervention group: Session 1: Routine care. Session 2: Cryotherapy will take place. Session 3: Acupressure will take place. Acupressure/Cryotherapy intervention group: Session 1: Routine care. Session 2: Acupressure will take place. Session 3: Cryotherapy will take place.
Main outcome variables
Pain score in numerical visual analogue pain scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170116031972N7
Registration date:2019-07-10, 1398/04/19
Registration timing:prospective
Last update:2019-07-10, 1398/04/19
Update count:0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of acupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis referred to the clinical centers of Kerman University of Medical Sciences, in 2019
Public title
The effect of accupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Being conscious
Having the ability of verbal communication
3 months passed the time of fistula embedding
At least 6 months passed the time of hemodialysis Initiation
Having an active medical document (Weekly three sessions and each session for 3 to 4 hours of hemodialysis)
In case of diabetes, their diabetes has been controlled (FBS range from 70 to 150 mg/dl and BS in the range of 120 to 250 mg/dl)
Exclusion criteria:
Receiving a sedative or opiate drug for 8 hours before hemodialysis
Excessive pain in other body parts
The presence of skin problem, insensibility, neuropathic disorders and peripheral vascular disease at the site of access to the vessels
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
samples will be randomly assigned into two blocks of 25 samples, 25 samples in acupressure/cryotherapy group and 25 samples in cryotherapy/acupressure group by Permuted Block Randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebnesina St, Jahad Blvd, Somaye Crossroad, Kerman
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.KMU.REC.1398.167
Health conditions studied
1
Description of health condition studied
acute postprocedural pain of needle entry into the arteriovenous fistula
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
pain score in numerical visual analogue pain scale
Timepoint
Session 1: Patient's pain will be measured under normal care conditions and after entering and fixing hemodialysis arterial-venous needles. Session 2: Patient's pain will be measured after cryotherapy and entering and fixing hemodialysis arterial-venous needles. Session 3: Patient's pain will be measured after acupressure and entering and fixing hemodialysis arterial-venous needles.
Method of measurement
The numerical visual analogue pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Cryotherapy/Acupressure intervention group: Session 1: routine care and no intervention will take place. Session 2: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula . After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure. Session 3: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before the needle is inserted.
Category
Other
2
Description
Acupressure/Cryotherapy intervention group: Session 1: routine care and no intervention will take place. Session 2: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before the needle is inserted. Session 3: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula. After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Kerman University of Medical Sciences
Full name of responsible person
Mahmood Nekoeimoghadam
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mahmood.nekoeimoghadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Ebnesina St, Jahad Blvd, Somaye Crossroad, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Student of M.Sc. in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3342 7901
Email
hosseini4173@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahlagha Dehghan
Position
Faculty member of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
m_dehghan86@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Student of M.Sc. in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3342 7901
Email
hosseini4173@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
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
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