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

Adiyaman University

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Other: nonpharmalogocial methods

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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adiyaman, Turkey, 02100
    • Adiyaman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupressure group; 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.	Other: nonpharmalogocial methods; neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
Experimental: masssage group; 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.	Other: nonpharmalogocial methods; neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
No Intervention: control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Oximeter Device	It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.	1 minute
Chronometer	Duration of crying and heel lancing procedure were recorded	2 minutes

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pain; neonate; massage; acupressure; heel lancing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 2018/1-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No