Evaluation of the Effect of Vibration on Heel Lance Pain Control in Premature Infant Admitted to Neonatal Intensive Care Unit( NICU) Department Ali Ibn Abi Talib in Zahedan in 1398
Evaluation of the Effect of Vibration on Heel Lance Pain Control in Premature Infant Admitted to Neonatal Intensive Care Unit Department Ali Ibn Abi Talib in Zahedan in 1398
Design
Samples are assigned randomly (lottery) blocks to two groups of therapeutic vibration and control group, each block size being equal. Clinical trial, a randomized blinded.
Settings and conduct
The methodology will be to select from among the infants with the criteria and criteria for entry into the study, based on input criteria from the target population, namely preterm infants with a fetal age of 30 to 36 weeks and a weight greater than 1500 grams in Neonatal Intensive Care Unit of Ali ibn Abi Talib hospital is located in Zahedan and will be assigned to two groups of vibration (group A) and control (group B). For blinding In this study, sampling will be done by nurse and interventions by the researcher. The sampler is also aware that the sample is either a control group or an intervention. All interventions will be captured by the video camera.
Participants/Inclusion and exclusion criteria
All preterm infants 30 to 36 weeks and no congenital anomalies, respiratory distress and whose parents have completed consent form.
Intervention groups
Group A, therapeutic vibration.
Group B, control and no intervention.
Main outcome variables
Pain: The score that the subject received after the end of the intervention by the pain measurement instrument used in preterm infants NIPS.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190530043765N1
Registration date:2019-06-09, 1398/03/19
Registration timing:prospective
Last update:2019-06-09, 1398/03/19
Update count:0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
Yasin Ghodsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 7573
Email address
yasin.ghodsi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Vibration on Heel Lance Pain Control in Premature Infant Admitted to Neonatal Intensive Care Unit( NICU) Department Ali Ibn Abi Talib in Zahedan in 1398
Public title
Evaluation of the Effect of Vibration on Heel Lance Pain Control in Premature Infant Admitted to Neonatal Intensive Care Unit( NICU) Department Ali Ibn Abi Talib in Zahedan in 1398
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pre-term infants with gestational age 30 to 36 weeks, weighing more than 1500 grams have.
Their vital signs are within the normal range.
Do not have severe respiratory distress.
No congenital or anomalous defects.
Their parents completed the consent form for participation in the research.
Mother does not have drug addiction during pregnancy.
Exclusion criteria:
Intubated newborn during the study.
Intubated the baby.
Failure in the first time of blood sampling.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible babies will be selected in 1398 according to the entry criteria from the NICU section of the Ali ibn Abi Talib hospital in Zahedan. Samples are assigned randomly (lottery) blocks to two groups of vibration and control group, the size of all blocks is equal. In this method, the number of qualified preterm infants in both groups will be equally chosen.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, sampling will be done by nurse and interventions by the researcher. The sampler is also aware that the sample is either a control group or an intervention. All the interventions will be recorded by video camera. First, the staff of the department to scan and complete the form of the NIPS questionnaire, the film will be reviewed and then the researcher will review the accuracy of the questionnaire and final score will be given.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hassabi Square, Janat Blvd, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2019-05-26, 1398/03/05
Ethics committee reference number
IR.ZAUMS.REC.1398.094
Health conditions studied
1
Description of health condition studied
The effect of vibration on pain relief from heel lance.
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain: The score that the subject will take after the end of the intervention by the pain measurement instrument used in the preterm infants NIPS, and has a score of 0 to 7.
Timepoint
Measuring pain during heel lance with and without vibration.
Method of measurement
By the pain measurement tool used in preterm infants: Neonatal Infant Pain Scale
Secondary outcomes
1
Description
Instrumentation of pain in term and preterm newborns before, during and after painful interventions such as blood sampling, venipuncture, vaccination and heel lance.
Timepoint
After sampling, the recorded video will be reviewed and rated.
Method of measurement
1.Cry, 2.Facial expression, 3.Breathing pattern, 4.Arms, 5.Legs, 6.State of Arousal.
Intervention groups
1
Description
Intervention group: Vibration during heel lance is performed on preterm infants who have criteria for entering the study. Then, pain measurement tools are completed in preterm infants and their pain score is measured.
Category
Treatment - Devices
2
Description
Control group: In this group, the blood from the heel without any intervention to be performed. The instrument for measuring pain in the preterm infants is completed and their pain score will be measured and then there will be a comparison between the pain score of the intervention group and the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali al-Ibn Abi Talib hospital in Zahedan
Full name of responsible person
Fereshteh Ghaljaei
Street address
Zahedan, Dr. Hassabi Square, Jannat Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5572
Fax
+98 54 3329 5572
Email
ghaljaei_f@zaums.ir
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
NoorMohamad Bakhshani
Street address
Dr Hasabie Square, Persian Gulf Blvd, Pardis Office Complex, Zahedan University of Medical Sciences and Health Services
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
Sistan and Baluchestan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ghaljaei_f@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ghaljaie_f@zaums.ac.ir
Web page address
http://zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ghaljaie_f@zaums.ac.ir
Web page address
http://zaums.ac.ir
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
The main outcomes of the participants are public.
When the data will become available and for how long
6 months after the results.
To whom data/document is available
The researchers in academic and scientific institutions.
Under which criteria data/document could be used
The statistical result.
From where data/document is obtainable
Faculty of Nursing and Midwifery, Zahedan Telephone: 05433442481 Postcode: 9816913396 Address: Mashahir Square, Nursing and Midwifery Faculty, Zahedan
What processes are involved for a request to access data/document