Determine the effects of massage and tapping on the duration and first success rate of peripheral intravenous catheter insertion in old patients admitted to Emergency department
Design
A randomized controlled clinical trial with four groups, parallel group
Settings and conduct
This study is performed in the Emergency ward of Imam Khomeini Hospital in Esfarayen. The study population are elder patients referred to this wards. After pilot sampling, samples were randomly divided into 4 groups by using Permuted block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 65 years old, catheter insertion difficulty rate is between 2 to 5 with Difficult Intravenous Access (DIVA) instrument.
Exclusion Criteria: The patient has emergency conditions Not willing to participate in the study catheter insertion Failure for first attempt
Intervention groups
In the massage group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand ( catheter insertion site) for one minute till change the color of the skin. The catheter N.20 will be inserted in the site of determined.
In the Tapping group, the blood pressure cuff is wrapped and Nurse will tap soft kicks from 5 c.m distance of patient hand for one minute.
In mixed group (massage and tapping) after closure of cuff, Expert nurse will rub patient hand. Then, soft kicks will be tapped from 5 c.m distance of patient hand for one minute.
In the control group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse without any other intervention will insert the catheter.
Main outcome variables
The main outcome variables including: duration and first attempt success rate for inserting of catheter that checked by checklist.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045773N3
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
seyed javad hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
s.j.hoseini2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of massage and tapping on the duration and first success rate of peripheral intravenous catheter insertion in aged patients
Public title
Comparing the effects of massage and tapping on success of catheter insertion
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Participants have age over than 65 years old
catheter insertion difficulty rate is between 2 to 5 with Difficult Intravenous Access (DIVA) instrument
Exclusion criteria:
The patient has emergency conditions
Not willing to participate in the study
catheter insertion Failure for first attempt
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. Random units are each of elderly patients that admitted to the emergency department. Also, The randomization tool is a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified.
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 of Esfarayen faculity of Medical Sciences
Street address
Faculity of Medical Sciences, Imam Reza St, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
۷۶۹۸١-۹۶۶١۸
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.ESFARAYENUMS.REC.1398.010
Health conditions studied
1
Description of health condition studied
Patients reffered to Emergency ward
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
First attempt success rate for inserting of peripheral venous catheter
Timepoint
Immediately after fixation of catheter on the skin
Method of measurement
Possible to injection of "water for injection" from top of the catheter without causing swelling at the top of catheter insertion
2
Description
Inserting of peripheral venous catheter duration
Timepoint
Since initiation catheter insertion until it is fixed in place
Method of measurement
Using the stopwatch
3
Description
The time spent to find a peripheral venous
Timepoint
Since the fasten of tourniquet to start inserting of peripheral venous catheter
Method of measurement
Using the stopwatch
4
Description
Patient satisfaction from each of protocols
Timepoint
After completion of catheter insertion
Method of measurement
Using the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the massage group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, site of catheter insertion will be disinfected with alcohol 70%. The catheter N.20 will be inserted in the site of determined.
Category
Other
2
Description
In the Tapping group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter insertion site) for 30 sec. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.
Category
Other
3
Description
In mixed group (massage and tapping) the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter insertion site) for one minute. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.
Category
Other
4
Description
In the control group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg for 30 sec. Expert nurse without any other intervention will determine site of catheter insertion and disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Esfarāyen
Full name of responsible person
Eshagh Ildarabadi
Street address
Esfarayen Faculty of medical science, Imam Reza S.t, Esfarāyen Town, North khorasan, IRAN
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
Info@esfrums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Eshagh Ildarabadi
Street address
Esfarayen Faculty of medical science, Imam Reza Street, Esfarāyen Town, North khorasan, IRAN
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
Info@esfrums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Member of Esfarayen faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences , Imama Reza S.t, Esfarāyen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
9661777944
Phone
0098 5831550000- 602
Email
s.j.hoseini2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Member of Esfarayen faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences , Imam Reza St, Esfarāyen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
96617-77944
Phone
+98 58 3155 0000-602
Email
s.j.hoseini2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences , Imam Reza S.t, Esfarāyen, North Khorasan, IRAN
City
Esfarayen
Province
North Khorasan
Postal code
96617-77944
Phone
+98 58 3155 0000-602
Email
s.j.hoseini2016@gmail.com
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Document will be registered "Pajouhan" system after completion of the study . Also, participants general information and the effectiveness of interventions will be recorded in the article.
When the data will become available and for how long
Accessibility after publish of article
To whom data/document is available
People interested in nursing scope
Under which criteria data/document could be used
People looking for ways to facilitate catheter insertion in pediatric who can access the data
From where data/document is obtainable
Esfarāyen Faculty of Medical Sciences, Imama Reza S.t, Esfarāyen, North Khorasan
What processes are involved for a request to access data/document
They can access to data through below email as soon as possible s.j.hoseini2016@gmail.com