the effect of mothers voice on arterial blood sampling on pain and physiological indicators in pediatrics hospitalized in pediatric intensive care unit
Effect of Mother Recorded Voice on Pain and Physiological Criteria During Arterial Blood Sampling in Pediatric Patients
Design
Participants will be selected in sequential method. they enter in two groups(A, B) with random allocation with 2 blocking .
Group A: Getting arterial blood sampling while listening to mother's voice.and then Getting arterial blood sampling without listening to mother's voice
Group A: Getting arterial blood sampling without listening to mother's voice and then Getting arterial blood sampling while listening to mother's voice.
Settings and conduct
The study will be cross-over. Participants will be divided into two groups A and B based on the 2 blocking method. In group A, blood sampling will be performed first listening of the mother's voice and then without the listening of mother's voice. In group B, blood sampling will be done first without the listening of mother's voice and then with the listening of mother's voice.
In both groups the headphones will be on the child's ear and the pain assessment will be done without knowing the status of the mother's listening or not. The data will be analyzed in the form of code and without information about the order of intervention.
Participants/Inclusion and exclusion criteria
Have at least 9 alertness levels based on Glasgow scale
No have hearing impairment
No be under ventilation
Do not take analgesic drugs at least three hours before sampling
No have developmental delay
No have cognitive disorders
No have neuromuscular disorders, including guillain barre and mental retardation
Intervention groups
Listening to mother's voice during arterial blood sampling
Main outcome variables
Pain and physiological criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N6
Registration date:2019-09-22, 1398/06/31
Registration timing:retrospective
Last update:2019-09-22, 1398/06/31
Update count:0
Registration date
2019-09-22, 1398/06/31
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-28, 1397/11/08
Expected recruitment end date
2019-03-28, 1398/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of mothers voice on arterial blood sampling on pain and physiological indicators in pediatrics hospitalized in pediatric intensive care unit
Public title
The effect of mothers voice on Pain and physiological indicators during arterial blood sampling and in children hospitalized in pediatric intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 9 alertness levels based on Glasgow scale
No have hearing impairment
No be under ventilation
No take analgesic drugs at least three hours before sampling
Lack of childhood developmental delay
No have cognitive disorders
No have Neuromuscular disorders, such as Guillain Barre and mental retardation
Exclusion criteria:
Age
From 2 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
Each child's pain is evaluated at an early stage by listening to the mother's voice during arterial blood collection and one more time without listening to the mother's voice during arterial blood transfusion.
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling will do in sequential method. random allocation will used with 2 blocking. The participants will be divided into two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Research assistance during the process of data gathering. will not know that The child listen to mother voice or not.
Data will be sent in coding (A,B) for analysis.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Before arterial blood sampling, during arterial blood sampling
Method of measurement
pain assessment comfort scale
2
Description
physiological indicators
Timepoint
Before arterial blood sampling, during arterial blood sampling
Method of measurement
Record from monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Getting arterial blood sampling while the child listen to mother's voice and after at least 24 hours getting arterial blood sampling while the child don't listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling
Category
Other
2
Description
Intervention group B: Getting arterial blood sampling while the child don't listen to mother's voice. and after at least 24 hours getting arterial blood sampling while the child listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling