Protocol summary

Study aim
Comparing the effect of cryotherapy and acupressure on pain intensity of arteriovenous fistula in female patients undergoing hemodialysis
Design
In this study, 42 female patients under hemodialysis were selected through fistula and entered the study, and the study is a one-way semi-experimental study in which each individual has control. for each patient, randomized intervention (cryotherapy or acupuncture)selected.
Settings and conduct
The researcher referred to hemodialysis ward in even and odd days and in the morning and evening, and selected eligible individuals based on non-random allocation No intervention: Arterio-venous hemodialysis needles were inserted by the nurse to the fistula. After completing the work and fixing the needles, pain was measured using a numerical tool. Patients were randomly assigned to cryotherapy or acupressure in the second session of hemodialysis. and third session received crayotherapy or acupressure (that did not receive in the second session) Cryotherapy intervention:It was done using a piece of cubic ice was placed inside a gauze and then inserted into the nylon and placed on the Hugo point in the patient's hand no fistula for 10 minutes (2 minutes rubbing and 15 seconds rest). Immediately after that ,the nurse inserted needle into the fistula and fixed ,the pain was measured. Acupressure intervention: It was done using a thumb-fist, the hand is oblique on the Hugo's point in the patient's hand no fistula for 10 minutes, alternately (2 minutes massage ,medium pressure, and 15 seconds rest), . Immediately after that ,the nurse inserted needle into the fistula and fixed ,the pain was measured. The instrument was used to measure the time of the hour and the pain was measured by an individual who was not aware of the type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria include: aged over 18 years, alertness, ability to communicate verbally, pass 3 months of fistula placement, no opioid, sleep pill or sedative from 8 hours before hemodialysis, no severe pain in other places, no Pacemaker, initiation of hemodialysis at least 3 months ago, patients with a fixed and active file (3 sessions every week each session 4 hours), no problem, lack of numbness, no neuropathy and peripheral vascular diseases around hemodialysis site (at the site of access to the vessels), no history of diabetes (or controlled if patient has diabetes). Exclusion criteria: dissatisfaction for participating in study.
Intervention groups
In this study, three stages (without intervention-intervention of cryotherapy and acupressure intervention) were performed in one group. Indeed, each individual had a control (herself) and we did not have separate control group.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180101038178N1
Registration date: 2018-02-17, 1396/11/28
Registration timing: retrospective

Last update: 2018-02-17, 1396/11/28
Update count: 0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Fatemeh Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3342 3902
Email address
f.hosseinzadeh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-16, 1395/11/28
Expected recruitment end date
2017-05-18, 1396/02/28
Actual recruitment start date
2017-02-16, 1395/11/28
Actual recruitment end date
2017-05-18, 1396/02/28
Trial completion date
empty
Scientific title
Comparing the effect of cryotherapy and acupressure on pain intensity of arteriovenous fistula cannulation in female patients undergoing hemodialysis
Public title
Comparing the effect of cryotherapy and acupressure on pain intensity of arteriovenous fistula cannulation in female patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Being alert The ability to communicate verbally The fistula is inserted three months ago No receive a medication for sedation from 8 hours before hemodialysis Lack of severe pain in other part of body No pacemaker Initiating hemodialysis at least 3 months ago Patients with a fixed and active file to undergo hemodialysis (three sessions in a week, 4 hours each session) No skin problem, No neuropathy, No peripheral vascular diseases in the area of access to vessels
Exclusion criteria:
Dissatisfaction to participate in the study
Age
From 46 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Actual sample size reached: 42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Intersection of Valiasr and Taleghani streets؛Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۳۳۱۹۱۱۸۶۵۱
Approval date
2017-02-02, 1395/11/14
Ethics committee reference number
IR.Shahed.REC.1395.199

Health conditions studied

1

Description of health condition studied
Hemodialysis, Arteriovenous Fistula, Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Three days - every other day
Method of measurement
Numeric pain rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: No intervention- The first stage of the study without any intervention after the needle was inserted into the fistula, the patient's pain was measured using a numerical instrument of pain.
Category
Prevention

2

Description
Cryotherapy intervention: The researcher put a piece of ice inside a gauze (because the ice melts in the gauze later), and then placed inside the nylon and set on the Hugo point (between thumb and pointing finger) in thepatient's hand no fistula and rubbed the place from the 10 minutes (2 minutes rubbing and 15 seconds rest) before the needle was inserted into the arteriovenous fistula. Then the fistula area was well disinfected and the needle inserted into the fistula by the nurse. Immediately after insertion of the needle and fixing it, the patients' pain was measured using a numerical instrument of pain by an individual who was not aware of the type of intervention
Category
Prevention

3

Description
Acupressure intervention: The researcher carried out using the thumb of the hand in a diagonal direction on the Hugo point (between thumb and pointing finger in the patient's hand no fistula ) 10 minutes before insertion of the needle, alternately (2 minutes massage, medium pressure (not too intense or very mild), and 15 seconds rest ). Then , the nurse inserted needles into the fistula and fixed it, after that the number of pain was measured by a person who was not aware of the type of intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa kerman Hospital
Full name of responsible person
Abbas Pardakhty
Street address
Shafa Hospital, Kerman; North Farabi Street
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Specialized clinic of Javad Alamem Kerman
Full name of responsible person
Mohammad Hossein Pour Ebrahimi
Street address
Specialized clinic of Javad Alamem Kerman؛Alley 25- North Abu Dhar St.
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34 3251 0025
Email
f.hosseinzadeh@ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kaysalari
Street address
University of Shahed; Persian Gulf highway opposite Imam Khomeini's shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3092
Email
kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Fatemeh Hosseinzadeh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Plaque 27 Ferdows Alley 9 Ferdows Avenue
City
Kerman
Province
Kerman
Postal code
7761618999
Phone
+98 34 3342 3902
Email
f.hosseinzadeh@shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nasrin Alaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 6, Faculty of Nursing and Midwifery, Shahed university, - junction of of Valiasr Aj and Taleghani ave. Tehran . Iran
City
Tehran
Province
Tehran
Postal code
1591715314
Phone
+98 216641859092
Email
alaei@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Hosseinzadeh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Plaque 27 Ferdows Alley 9 Ferdows Avenue
City
Zarand
Province
Kerman
Postal code
7761618999
Phone
+98 34 3342 3902
Email
f.hosseinzadeh@shahed.ac.ir

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
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