Determining the effect of massage therapy at Hugo point on venous catheter entry pain
Design
How to select samples at random is simple; So that a set of 68 numbers are randomly selected and written; Then, each patient who entered the relevant sections according to the selected number, for example, enters the study. Then, they are randomly divided into two groups: Control group (34 people) 2. Intervention group (34 people).
Settings and conduct
The study will be performed with the participation of 68 people referring to the inpatient wards of Imam Khomeini Hospital in Ilam city. . Before the venous catheter is inserted, the site of the hand Hugo point from which the vein is to be removed is massaged in a circular motion, gently and at medium pressure. In all samples in the two groups studied, the angiocatheter used will be pink and number 20.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the severity of pain due to which people have been referred to the hospital; Awareness of place, time and person; Ability to communicate and no psychological problems in the client. Exclusion criteria: unwillingness to cooperate; Lack of awareness of the client about the place, time and person; Use of pain relievers eight hours before the procedure for venipuncture, fractures and inflammation at the massage point
Intervention groups
Massage in the intervention group is performed for 3 minutes before and during the Hugo point venipuncture procedure. Hugo is a spot on the palm of the hand between the thumb and forefinger. Before the venous catheter is inserted, the site of the hand Hugo point from which the vein is to be removed is massaged in a circular motion, gently and at medium pressure.Transfusion in the control or control group will be performed in the usual way.
Main outcome variables
Reduction of pain caused by catheter insertion using Hugo point massage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211012052746N1
Registration date:2021-10-21, 1400/07/29
Registration timing:prospective
Last update:2021-10-21, 1400/07/29
Update count:0
Registration date
2021-10-21, 1400/07/29
Registrant information
Name
Razyeh Valadbeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 9388
Email address
razyehvaladbeigi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-30, 1400/08/08
Expected recruitment end date
2022-04-22, 1401/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage therapy at Hugo point on venous catheter pain
Public title
The effect of massage therapy at Hugo point on venous catheter pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People are 18 to 75 years old
The severity of the pain for which people have been referred to the hospital is less than 6 (moderate pain) according to the NRS
Awareness of place, time and person; Ability to communicate and no psychological problems in the client.
Exclusion criteria:
Reluctance to cooperate
Lack of awareness of the client to the place, time and person
The client's pain for which he or she was referred to the hospital is greater than 6 according to the NRS
Use of pain relievers eight hours before the transfusion procedure
Fractures and inflammation at the massage point
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
How to select samples for 68 people is a simple randomization method by drawing lots; first I write the number of beds in that section on each card and then we put the cards in a box and mix them together and after adding all the cards in the box, half of the cards are randomly taken out. Then, each patient that belongs to the selected number in the lottery list is entered into the study as a sample. Sampling in this study is without substitution. The unit of randomization is individual. Individuals included in the study are randomly divided into two groups: Control group (34 people) 2. Intervention group (34 people). In this grouping, it is tried that the people of the two groups are selected in terms of factors such as age and the same sex. In this research, no concealment has been done.
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 Ilam University of Medical Sciences
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of the Martyrs of Momeni Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.MEDILAM.REC.1400.141
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Intravenous catheter entry pain
Timepoint
3 minutes during and before the venipuncture procedure
Method of measurement
NRS numerical rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, massage is performed for 3 minutes before and during the venipuncture procedure at Hugo point. Hugo is a spot on the palm of the hand between the thumb and forefinger. Before the venous catheter is inserted, the site of the hand Hugo point from which the vein is to be removed is massaged in a circular, gentle, medium-pressure manner. In all samples in the two study groups, the angiocatheter used will be pink and number 20. The scale for measuring pain in this study will be the use of the NRS numerical scale. On this scale, a person rates their pain using a scale of 0 to 10. Zero means painless and 10 means the worst pain situation: 0: no pain; 1-2-3: mild pain; 4-5-6: moderate to moderate pain; 7-8-9-10: Severe pain is considered.
Category
Prevention
2
Description
Control group: In this group, the venipuncture department will be performed in the usual way and no intervention will be done for this group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Razyeh Valadbeigi
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Phone
+98 84 3222 9388
Fax
Email
razyehvaladbeigi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Razyeh Valadbeigi
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Phone
+98 84 3222 9388
Email
razyehvaladbeigi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Razyeh Valadbeigi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Phone
+98 84 3222 9388
Email
razyehvaladbeigi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Razyeh Valadbeigi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Phone
+98 84 3222 9388
Email
razyehvaladbeigi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Razyeh Valadbeigi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley
City
Ilam
Province
Ilam
Postal code
6931175371
Phone
+98 84 3222 9388
Email
razyehvaladbeigi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The present study is a clinical trial study that will be performed with the participation of 68 people referring to the inpatient wards of Imam Khomeini Hospital in Ilam. They are randomly selected and written; then, each patient who entered the relevant sections according to the selected number, for example, is included in the study. Then, they are randomly classified into two groups. وند Become: 1. Control group (34 people) 2. Intervention group (34 people).
When the data will become available and for how long
Sample takes place from 1400/8/8 to 1401/2/2
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, people working in industry and research students
Under which criteria data/document could be used
Inclusion criteria: people aged 18 to 75 years; The severity of the pain for which people have been referred to the hospital is less than 6 (moderate pain) according to the NRS; Awareness of place, time and person; Ability to communicate and no psychological problems in the client. Exclusion criteria: unwillingness to cooperate; Lack of awareness of the client about the place, time and person; The client's pain for which he or she was referred to the hospital is greater than 6 according to the NRS; Use of pain relievers eight hours before the procedure for venipuncture, fractures and inflammation at the massage point
From where data/document is obtainable
Via email razyehvaladbeigi@gmail.com or postal address of Ilam _Janbazan neighborhood. Malek Shoara Street, corner of Shohada Momeni alley
What processes are involved for a request to access data/document