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

NCT03906552 | Completed

• 1 other identifier: 2018/1-5
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

acupressure; massage; pain; neonate; heel lancing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pulse Oximeter Device

  1 minute

• Chronometer

  2 minutes

Study Arms (3)

acupressure group

EXPERIMENTAL

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

masssage group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

nonpharmalogocial methods OTHER

neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure

acupressure group; masssage group

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adiyaman University

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adiyaman University School of Health

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: January 23, 2018
• Primary Completion: January 23, 2018
• Study Completion: December 1, 2018
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

TU (1)