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Completed

NCT Number: NCT03906552

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adiyaman University

Adıyaman, 02100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nonpharmalogocial methods

Other

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

Primary outcomes

  1. Pain Scale

    Time frame: 1 minute

    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

Other outcomes

  1. Pulse Oximeter Device

    Time frame: 1 minute

    It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.

  2. Chronometer

    Time frame: 2 minutes

    Duration of crying and heel lancing procedure were recorded

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

Adiyaman University

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2019
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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