Study of the effect of hand reflexology on pain, anxiety and hemodynamic parameters in children who are candidates for surgery during Insertion of the Intravenous (IV) Catheter
The effect of hand reflexology on pain, hemodynamic exercises in children undergoing surgery during intravenous line
Design
The present study is a double blind randomized clinical trial with two intervention and control groups. The number of 88 children eligible for the study were entered into the study using the available method and were randomly divided into two groups of reflexology and control using the block method (blocks of four and with an allocation ratio of 1:1 using a random table).
Settings and conduct
Subjects will be divided into two equal control and intervention groups using block randomization method. Reflexology will be performed for 5 minutes before placing the intravenous line in the intervention group. Two trained nurses will measure pain intensity, anxiety and hemodynamic parameters independently. This study will be conducted in the hospitals of Qom University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: 3-6 year old children with full consciousness and physiological stability
Not having mental disability
Decreased sensitivity to pain caused by any other disease
No use of painkillers, sedatives, corticosteroids or relaxants
Hospitalization for the first time
Absence of pain during sampling
Exclusion criteria:
Inability to place an IV line in the first step and the child's non-cooperation during the implementation of interventions
Intervention groups
In order to perform the intervention in the intervention group, the researcher will perform a massage on the skin of the hand with slow stroking movements with moderate pressure of the palm five minutes before taking the vein and during insertion.
In the control group, the establishment of the venous route will be done without intervention and based on the department's routine
Main outcome variables
Pain, hemodynamic parameters remain stable
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056718N2
Registration date:2023-02-04, 1401/11/15
Registration timing:prospective
Last update:2023-02-04, 1401/11/15
Update count:0
Registration date
2023-02-04, 1401/11/15
Registrant information
Name
Hossein Sharafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3197 1087
Email address
hsharafi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of hand reflexology on pain, anxiety and hemodynamic parameters in children who are candidates for surgery during Insertion of the Intravenous (IV) Catheter
Public title
The effect of hand reflexology on pain, anxiety and hemodynamic parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3-6 year old children
Full consciousness
Physiological stability
Not having mental disability
Decreased sensitivity to pain caused by any other disease
No use of painkillers, sedatives, corticosteroids or relaxants
Hospitalization for the first time
Absence of pain during sampling
Exclusion criteria:
Inability to place an IV line in the first attempt
Child's non-cooperation during interventions
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
children who are eligible for the study are entered into the study using the available method and are randomly assigned to two intervention and control groups using the block method (blocks of four and with an allocation ratio of 1:1 using a random number table).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants will not know about the study due to their young age, and only the child's parents will know. Also, if the child refuses touch and reflexology, he will be excluded from the study. Two nurses who complete the evaluation questionnaires. And the data analyst will not know about the control and intervention groups. After the intervention, the two nurse assessors will enter the operating room and evaluate the child at the designated times.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Before, immediately and 5 minutes after the intervention
Method of measurement
Face, Legs, Activity, Cry, Consolability scale
2
Description
Anxiety related to Reflexology
Timepoint
Before, immediately and 5 minutes after the intervention
Method of measurement
Modified Yale Preoperative Anxiety Scale
Secondary outcomes
1
Description
Hemodynamic parameters
Timepoint
Before, immediately and 5 minutes after the intervention
Method of measurement
Digital heart monitoring system
Intervention groups
1
Description
Intervention group: Different parts of the hands and arms, with special attention to the areas related to the central nervous system, pituitary gland, spine, solar plexus and head reflexes of patients. For example, the middle of the thumb, which is related to the pituitary reflex, and the side that is related to the spinal reflex. This will be done using a sliding thumb motion, pressing and moving in each area
Category
Treatment - Other
2
Description
Control group: In the control group, the venous route will be established without intervention and based on the routine of the department. The variables in the control group will be measured as before in the intervention group, immediately after vein extraction and 5 minutes after placing the venous catheter by the same two nurses.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Shahid Beheshti Hospita
Full name of responsible person
Majid Moghadam
Street address
Qom - Shahid Beheshti Blvd.
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2824
Fax
+98 25 3612 2855
Email
bmc@muq.ac.ir
Web page address
https://bmc.muq.ac.ir/
2
Recruitment center
Name of recruitment center
Khyerin Salamat educational research and therapeutic complex
Full name of responsible person
Javad Hakim Elahi
Street address
Qom - Shahid Del Azar St
City
Qom
Province
Ghoum
Postal code
7335537158
Phone
+98 25 3721 1061
Email
Nekoeihospital@muq.ac.ir
Web page address
https://nekuei.muq.ac.ir/
3
Recruitment center
Name of recruitment center
Qom Kamkar-Arabnia Hospital
Full name of responsible person
Dr. Seyed Alireza Chavoshizadeh
Street address
Qom . 19th Street (Bajek)
City
Qom
Province
Ghoum
Postal code
3713614975
Phone
+98 25 3718 5000
Email
h_sharafi68@yahoo.com
Web page address
https://kamkar.muq.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Mesri
Street address
Qom - Shahid Lavasani St. (Saheli) - Qom University of Medical Sciences and Healthcare Services
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1111
Email
hsharafi@muq.ac.ir
Web page address
https://muq.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences ,pardisan
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
009892531971087
Email
h_sharafi68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
+98 25 3197 1087
Email
h_sharafi68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Sharafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan.Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3749153434
Phone
+98 25 3197 1087
Email
h_sharafi68@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The second half of 2023
To whom data/document is available
There is no restriction on access to the results
Under which criteria data/document could be used
There are no restrictions after de-identifying people
What processes are involved for a request to access data/document
The request for the data that is irrefutably identified will be made through the e-mail introduced by the researcher, and the request will be reviewed in less than 10 days and the requested data will be provided to the requester.