Comparison of the effect of superficial stroke massage and cryotherapy on physiological indicators and pain intensity caused by venous sampling in hospitalized children
Determining the effect of stroke massage and cryotherapy on physiological indicators and pain caused by venous sampling in children
Design
A three-group clinical trial with a control group, with parallel groups, purposive sampling based on inclusion criteria and random allocation by permuted block randomization using web-based software and fixed blocks of 6, without blinding and on it will be done on 75 patients
Settings and conduct
The environment of this research is Amirkabir Hospital in Arak city. Informed consent will be obtained from the parents of children eligible to participate in the study. In the stroke massage group, the training class will be held in a one-hour session by the method of lectures, video showing and massage practice on the model. Then they are asked to perform massage on their child for 30 minutes before venous sampling. In the cryotherapy group, an ice pack (5x5) wrapped in a cloth cover is placed on the site by the mother 3 minutes before venous sampling. Physiological parameters including heart rate and oxygen saturation before, during and 5 minutes after venous sampling will be checked and recorded in all three groups. Pain behavior scale will be checked during and 5 minutes after sampling.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Age range from 3 to 8 years
Intervention groups
Stroke massage group (A)
Cryotherapy group (B)
control group (C)
Main outcome variables
Determination of pain intensity and physiological indicators in three groups of stroke massage, cold therapy and control group before, during and after the procedure in children under study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240620062194N1
Registration date:2024-08-14, 1403/05/24
Registration timing:registered_while_recruiting
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Somaye Sayahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3501
Email address
s.sayahi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-04, 1403/05/14
Expected recruitment end date
2024-10-05, 1403/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of superficial stroke massage and cryotherapy on physiological indicators and pain intensity caused by venous sampling in hospitalized children
Public title
Comparison of the effect of superficial stroke massage and cryotherapy on physiological indicators and pain intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age range from 3 to 8 years
Exclusion criteria:
The presence of a wound or lesion on the skin where the intervention is performed
Failure of venous sampling in the first attempt
Age
From 3 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this study was done using the convenient method, then the samples will be allocated to interventions and control groups using permuted block randomization. Using web-based software and fixed blocks of 6, the samples will be allocated to three cryotherapy groups (A), stroke massage group (B) and control group (C). Opaque envelopes will be used to hide the random allocation. The envelope will be prepared according to the sample volume and each of the sequences obtained in the previous step will be recorded on a card and placed in the envelope. In order to preserve the random sequence, the envelopes will be numbered sequentially. The envelopes will be opened according to the order of the participants in the study and the desired group of the participant will be determined
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
Research Ethics Committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
646
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
IR.ARAKMU.REC.1402.235
Health conditions studied
1
Description of health condition studied
Pain intensity in venous sampling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of pain intensity and physiological indicators in three groups of massage, cold therapy and control group before, during and after venous sampling in children under study.
Timepoint
Measurement of physiological subjects before venous sampling and during venous sampling and 5 minutes after venous sampling, measurement of pain intensity during venous sampling and 5 minutes after venous sampling
Method of measurement
FALCC scale and pulse oximeter device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Stroke massage, Massage for 30 minutes before venous sampling and in the form of circular movements of fingers and palms superficially from the base of the skull to the sacral area on both sides of the spine and along the child's shoulders, which will be performed by the mother.In the stroke massage group, the training class will be held in 1 one-hour session by lecture method, showing the video and practicing massage on the model in the ward's treatment room. The correct performance of massage and the correct understanding of all mothers from massage training will be controlled by the researcher by observing the massage performed by mothers on the model.
Category
Rehabilitation
2
Description
Intervention group: Cryotherapy,Using a small ice bag (5x5) wrapped in a cloth cover and placed by the mother on the catheter insertion site for 3 minutes before performing venous sampling.
Category
Rehabilitation
3
Description
Control group: Control, They receive routine hospital care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Medical Education Center
Full name of responsible person
somaye sayahi
Street address
Unit 46,12th floor,Sepenta Tower,South Mirzai Shirazi Street,Arak
City
Arak
Province
Markazi
Postal code
3815713733
Phone
+98 86 3325 6641
Email
sayahi_s@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
646
Phone
+98 86 3417 3501
Email
dr_hekmat@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
somaye sayahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Unit 46, 12th floor, Sepenta Tower, South Mirzai Shirazi Street
City
Arak
Province
Markazi
Postal code
3815713733
Phone
+98 86 3417 3502
Email
sayahi_s@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
somaye sayahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Unit 46, 12th floor, Sepenta Tower, South Mirzai Shirazi Street
City
Arak
Province
Markazi
Postal code
3815713733
Phone
+98 86 3417 3503
Email
sayahi_s@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somaye Sayahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Unit 46, 12th floor, Sepenta Tower, South Mirzai Shirazi Street
City
Arak
Province
Markazi
Postal code
3815713733
Phone
+98 86 3417 3504
Email
sayahi_s@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
Not applicable
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