search
Back to results

Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance (heellance)

Primary Purpose

Pain, Acute, Comfort

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
breastfeeding
Breastfeeding and Shotblocker
shotblocker
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute focused on measuring breastfeeding, shotblocker

Eligibility Criteria

1 Day - 10 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birth week is between 34-42 weeks,
  • Postnatal in the first 10 days
  • Birth weight is between 2500-4000 grams,
  • Stable general condition,
  • Being with her mother and literate,
  • Breastfeeding,
  • Newborns of mothers who agreed to participate in the study

Exclusion Criteria:

  • In need of oxygen support,
  • Unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker)
  • Needing parenteral nutrition,
  • Receiving analgesic treatment,
  • Having physical, metabolic and genetic diseases,
  • Having a mental or mental health problem in the mother
  • Non-breastfed newborns
  • Newborns hospitalized in the 3rd and 4th level neonatal intensive care unit

Sites / Locations

  • Gülçin Özalp Gerçeker
  • Dr. Behçet Uz Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Breastfeeding intervention

Shotblocker intervention

Breastfeeding and Shotblocker intervention

Control group/ Standard Care

Arm Description

The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. If necessary, the researcher may verbally warn the mother in a calm tone to continue breastfeeding throughout the procedure. During the resting period (last 2 minutes) after the blood draw is completed, the baby stays on the mother's lap.

2 minutes before the procedure, the baby will be placed on the mother's lap. ShotBlocker is a small plastic tool that is blunt, short, has many points in contact with the skin, does not contain drugs, is in the shape of a horseshoe, invasive interventions can be applied through the space in the middle. It is positioned on the skin before the invasive procedure. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.

The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.

The baby is placed on the mother's lap 2 minutes before the procedure and the mother is provided to hold the baby effectively and graspingly. Standard heel lance procedure is applied. No additional interventions are applied to the baby. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.

Outcomes

Primary Outcome Measures

Neonatal Infant Pain Scale (NIPS)
Turkish validity and reliability were established. Reliability values were found to be 0.83, 0.83, 0.86 before, during and after the procedure, respectively. Newborn infant pain scale is a likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).
The Newborn Comfort Behavior Scale (NEAS)
The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies.his scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension and muscle tone.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2022
Last Updated
March 3, 2023
Sponsor
Dokuz Eylul University
search

1. Study Identification

Unique Protocol Identification Number
NCT05246787
Brief Title
Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance
Acronym
heellance
Official Title
The Effect of the Shotblocker and Breastfeeding on Pain and Comfort Level During Heel Lance Procedure in Newborns: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in newborns. This study was planned to evaluate the effect of non-pharmacological interventions on the pain and comfort level of newborns, whose heel blood will be taken in the 1st Level Neonatal Intensive Care Unit.
Detailed Description
Hypotheses H1: Newborns who undergo breastfeeding attempt during heel lance procedure feel less pain and have a higher comfort level. H2: Newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance procedure feel less pain and have a higher comfort level. H3: Newborns who undergo shotblocker intervention during heel lance procedure feel less pain and have a higher comfort level. H4: There are a difference between the comfort levels, HR and PO2 of newborns in terms of group, group-time and time according to the intervention applied. Data collection process Mothers of newborns whose heel blood will be taken will be informed about the research. Consent will be obtained from the mother regarding the video recording during the heel lance precedure. After informed consent is obtained, it will be determined which group the newborn belongs to by stratified randomization. A standard approach will be applied to all newborns. Standard approach involves performing the heel lance procedure on the caregiver's lap. Heel lance procedure will be scheduled between 09:00 and 10:00 in the morning, one hour after babies are breastfed. Babies to be included in the study in each group; they will be in their beds, in the undisturbed rest period, until 30 minutes before the start of the test. All babies; 2 minutes before, during and up to 2 minutes after blood collection; they will be video-recorded including their heart rate, faces, and upper and lower extremities (especially the heel to be operated). No additional care will be given to ensure physiological stability during each intervention (breastfeeding, shotblocker, etc.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Comfort
Keywords
breastfeeding, shotblocker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
attempt will be videotaped, outcome evaluators will be blind
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding intervention
Arm Type
Experimental
Arm Description
The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. If necessary, the researcher may verbally warn the mother in a calm tone to continue breastfeeding throughout the procedure. During the resting period (last 2 minutes) after the blood draw is completed, the baby stays on the mother's lap.
Arm Title
Shotblocker intervention
Arm Type
Experimental
Arm Description
2 minutes before the procedure, the baby will be placed on the mother's lap. ShotBlocker is a small plastic tool that is blunt, short, has many points in contact with the skin, does not contain drugs, is in the shape of a horseshoe, invasive interventions can be applied through the space in the middle. It is positioned on the skin before the invasive procedure. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
Arm Title
Breastfeeding and Shotblocker intervention
Arm Type
Experimental
Arm Description
The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
Arm Title
Control group/ Standard Care
Arm Type
No Intervention
Arm Description
The baby is placed on the mother's lap 2 minutes before the procedure and the mother is provided to hold the baby effectively and graspingly. Standard heel lance procedure is applied. No additional interventions are applied to the baby. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
Intervention Type
Behavioral
Intervention Name(s)
breastfeeding
Intervention Description
nonphamacological methods
Intervention Type
Combination Product
Intervention Name(s)
Breastfeeding and Shotblocker
Intervention Description
combined Breastfeeding and Shotblocker device
Intervention Type
Device
Intervention Name(s)
shotblocker
Intervention Description
it is a small plastic tool
Primary Outcome Measure Information:
Title
Neonatal Infant Pain Scale (NIPS)
Description
Turkish validity and reliability were established. Reliability values were found to be 0.83, 0.83, 0.86 before, during and after the procedure, respectively. Newborn infant pain scale is a likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).
Time Frame
during the heel lance
Title
The Newborn Comfort Behavior Scale (NEAS)
Description
The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies.his scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension and muscle tone.
Time Frame
during the heel lance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birth week is between 34-42 weeks, Postnatal in the first 10 days Birth weight is between 2500-4000 grams, Stable general condition, Being with her mother and literate, Breastfeeding, Newborns of mothers who agreed to participate in the study Exclusion Criteria: In need of oxygen support, Unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker) Needing parenteral nutrition, Receiving analgesic treatment, Having physical, metabolic and genetic diseases, Having a mental or mental health problem in the mother Non-breastfed newborns Newborns hospitalized in the 3rd and 4th level neonatal intensive care unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD
Organizational Affiliation
RN, PhD, Assoc. Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dr. Behçet Uz Children Hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

We'll reach out to this number within 24 hrs