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Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nonpharmalogocial methods
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain focused on measuring acupressure, massage, pain, neonate, heel lancing

Eligibility Criteria

1 Day - 2 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • having 2500-4000 gr body weight and being term neonates,
  • having APGAR score of over 7 five minutes after birth,
  • having no health problems detected in the newborn examination after birth,
  • having received no painful interventions apart from Hepatitis B and Kvit after birth,
  • being with the mother and being fed orally,
  • having had breast milk within 30 minutes before heel lancing
  • having a clean diaper.

Sites / Locations

  • Adiyaman University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

acupressure group

masssage group

control group

Arm Description

2 neonates did not calm down before heel lancing; oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well. Acupressure was performed when the mother was holding the neonate on her arm. For two minutes, acupressure was performed in the acupressure points (Kun Lun (UB60) and Taixi (K3). Each point was applied acupressure for 60 seconds, and heel lancing was performed right after this procedure. The acupuncture points that Kun Lun (UB60) and Taixi (K3) are on the side of the ankle.

oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). Foot massage was performed when the mother was holding the neonate on her arm. Each neonate was given foot massage for two minutes, and heel lancing was performed right after the massage.

oxygen saturation and heart rate values of 1 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). No application was made to theneonates in the control group before heel lancing procedure

Outcomes

Primary Outcome Measures

Pain Scale
Neonatal Infant Pain Scale (NIPS): The scale was developed by Lawrence et al. in 1993 in order to asses the behavioral and physiological pain responses of premature and term neonates. The scale consists of five behavioral and one physiological sections including facial expression, crying, breathing, arm and leg movements, and alertness. Total scores range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicates mild to moderate pain, and >4 indicates severe pain. Higher scores indicate more severe pain. In the study of Lawrence et al., NIPS 's Cronbach's Alpha 0.92 found (Larwence et al. 1993). The scale was adapted to Turkish by Akdovan, NIPS is used for the assessment of procedural pain of the premature and term neonates. Akdovan found the Cronbach's Alpha value to be 0.83. The pain intensity of neonates was evaluated during and 1 minute after heel lancing procedure

Secondary Outcome Measures

Full Information

First Posted
April 4, 2019
Last Updated
April 4, 2019
Sponsor
Adiyaman University Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03906552
Brief Title
Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates
Official Title
Adiyaman University
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates. Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.
Detailed Description
Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
acupressure, massage, pain, neonate, heel lancing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
randomized controlled trial
Masking
Investigator
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupressure group
Arm Type
Experimental
Arm Description
2 neonates did not calm down before heel lancing; oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well. Acupressure was performed when the mother was holding the neonate on her arm. For two minutes, acupressure was performed in the acupressure points (Kun Lun (UB60) and Taixi (K3). Each point was applied acupressure for 60 seconds, and heel lancing was performed right after this procedure. The acupuncture points that Kun Lun (UB60) and Taixi (K3) are on the side of the ankle.
Arm Title
masssage group
Arm Type
Experimental
Arm Description
oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). Foot massage was performed when the mother was holding the neonate on her arm. Each neonate was given foot massage for two minutes, and heel lancing was performed right after the massage.
Arm Title
control group
Arm Type
No Intervention
Arm Description
oxygen saturation and heart rate values of 1 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). No application was made to theneonates in the control group before heel lancing procedure
Intervention Type
Other
Intervention Name(s)
nonpharmalogocial methods
Intervention Description
neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
Primary Outcome Measure Information:
Title
Pain Scale
Description
Neonatal Infant Pain Scale (NIPS): The scale was developed by Lawrence et al. in 1993 in order to asses the behavioral and physiological pain responses of premature and term neonates. The scale consists of five behavioral and one physiological sections including facial expression, crying, breathing, arm and leg movements, and alertness. Total scores range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicates mild to moderate pain, and >4 indicates severe pain. Higher scores indicate more severe pain. In the study of Lawrence et al., NIPS 's Cronbach's Alpha 0.92 found (Larwence et al. 1993). The scale was adapted to Turkish by Akdovan, NIPS is used for the assessment of procedural pain of the premature and term neonates. Akdovan found the Cronbach's Alpha value to be 0.83. The pain intensity of neonates was evaluated during and 1 minute after heel lancing procedure
Time Frame
1 minute
Other Pre-specified Outcome Measures:
Title
Pulse Oximeter Device
Description
It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.
Time Frame
1 minute
Title
Chronometer
Description
Duration of crying and heel lancing procedure were recorded
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: having 2500-4000 gr body weight and being term neonates, having APGAR score of over 7 five minutes after birth, having no health problems detected in the newborn examination after birth, having received no painful interventions apart from Hepatitis B and Kvit after birth, being with the mother and being fed orally, having had breast milk within 30 minutes before heel lancing having a clean diaper.
Facility Information:
Facility Name
Adiyaman University
City
Adiyaman
ZIP/Postal Code
02100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates

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