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The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625010
Recruitment Status : Completed
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Bandırma Onyedi Eylül University
Information provided by (Responsible Party):
Sevil Inal, Istanbul University-Cerrahpasa

Brief Summary:

This study was planned to evaluate the effect of two different non-pharmacologic pain relief methods (swaddling and maternal holding) on healthy term newborn's pain levels during heel stick.

Study hypotheses are; Hypothesis 1. Swaddling is effective at relieving pain due to heel stick procedures in newborns. Hypothesis 2. Maternal holding is effective at relieving pain due to heel stick in newborns. Hypothesis 3. Maternal holding is more effective than swaddling at relieving pain due to heel stick in newborns.


Condition or disease Intervention/treatment Phase
Newborn Pain Maternal; Procedure Needle Stick Other: Swaddling Other: Maternal holding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : December 30, 2016

Arm Intervention/treatment
Experimental: Group 2 (Swaddling group)
Swaddling group: Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.
Other: Swaddling
Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.
Other Name: Group 2

Experimental: Group 3 (Maternal Holding group)
Maternal holding group: Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.
Other: Maternal holding
Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.
Other Name: Group 3

No Intervention: Group 1
In the control group, the heel stick procedures were conducted using the standard method and the neonates received no interventions during the procedures.



Primary Outcome Measures :
  1. NIPS (Neonatal Infant Pain Scale) [ Time Frame: Pain levels of the newborns evaluated during the procedures ]
    Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.


Secondary Outcome Measures :
  1. Total criying time [ Time Frame: The time of the procedure was measured from the beginning to the end of the heel stick procedure. ]
    The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying.

  2. The time to first calming [ Time Frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) ]
    The calming time was measured from the time of the first cry to the first calming time.



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • full term neonates (38-42 weeks of gestation)
  • underwent heel stick blood drawing for routine metabolic screening,
  • aged 2 to 4 days
  • passed the hearing screening

Exclusion Criteria:

  • Congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625010


Locations
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Turkey
Sevil İnal
İstanbul, Büyükçekmece, Turkey, 34500
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Bandırma Onyedi Eylül University
Investigators
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Principal Investigator: Leyla Erdim, Dr Istanbul University-Cerrahpasa
Publications of Results:
Other Publications:
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Responsible Party: Sevil Inal, Prof. Dr., Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04625010    
Other Study ID Numbers: IstanbullUC
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I did not find It appropriate to share it.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevil Inal, Istanbul University-Cerrahpasa:
Newborn
Pain management
Swaddling
Maternal holding
Heel stick
Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries