Objectives: The effect of facilitated tucking on heel stick pain in preterm infants.
Design: This is a cross over clinical trial.
Setting and conduct: In this study 40 newborns hospitalized in neonatal intensive care unit in Amir Kabir hospital of Arak will be selected purposively and allocated randomly into two groups.
Inclusion criteria: Gestational Age between 32-36 weeks; Weight more than 1200 grams; Body temperature between 36-37.2 °C; Absence of hypoglycemia or hyperglycemia; Not taking analgesics or anti-epileptic drugs 4 hours before intervention; Not having congenital malformations, seizure, and intracranial hemorrhage; Not performing other painful procedures at least half an hour before intervention; No need for mechanical ventilation
Exclusion criteria: More than one try for blood sampling; Parental refusal of participating in the study
Intervention: The study will be done in two stages. In the first stage, the two groups will be selected randomly. In group 1, two minutes before blood sampling, the newborn will be assessed by Premature Infant Pain Profile (PIPP). Then the newborn will be put in facilitated tucking position by the nurse, and this will be continued until 3 minutes after blood sampling. Assessment with PIPP will be done again, during and 3 minutes after blood sampling. In group 2, this process will be done but not in facilitated tucking position. In the second stage, blood sampling in group 2 will be done in facilitated tucking position and in group 1 in the routine position. The collected data will be compared in three phases and in two groups.
Main outcome variables: Newborn pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604041788N16
Registration date:2016-09-12, 1395/06/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Government sources
Expected recruitment start date
2016-03-04, 1394/12/14
Expected recruitment end date
2016-06-03, 1395/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of facilitated tucking on heel stick pain in preterm infants
Public title
The influence of being in facilitated tucking on heel stick pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Gestational Age between 32-36 weeks; Weight more than 1200 grams; Body temperature between 36-37.2 °C; Absence of hypoglycemia or hyperglycemia; Not taking analgesics or anti-epileptic drugs 4 hours before intervention; Not having congenital malformations, seizure, and intracranial hemorrhage; Not performing other painful procedures at least half an hour before intervention; No need for mechanical ventilation
Exclusion criteria: More than one try for blood sampling; Parental refusal of participating in the study
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomized blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
1996713883
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
IR.IUMS.REC.1394.9211451203
Health conditions studied
1
Description of health condition studied
Heel pain during blood sampling
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
Pain in infants
Timepoint
Before intervention, During intervention and 3 minutes after intervention
Method of measurement
Premature Infant Pain Profile (PIPP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: two minutes before blood sampling, the newborn will be assessed by Premature Infant Pain Profile (PIPP). Then the newborn will be put in facilitated tucking position by the nurse, and this will be continued until 3 minutes after blood sampling. Assessment with PIPP will be done again, during and 3 minutes after blood sampling. For second time, the blood sampling will be done in routine position and PIPP will be measured before and after that.
Category
Prevention
2
Description
Intervention group 2: at the first time the process will be done in routine position and Premature Infant Pain Profile (PIPP) will be measured before and after the procedure. In the second time, two minutes before blood sampling, the newborn will be assessed by PIPP. Then the newborn will be put in facilitated tucking position by the nurse, and this will be continued until 3 minutes after blood sampling. Assessment with PIPP will be done again, during and 3 minutes after blood sampling.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Samane Davari Shalamzari
Street address
Amir Kabir Hospital, Parastar sq, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences