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

Acute Pain Clinical Trial

Official title:

Adiyaman University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906552
• Other study ID #: 2018/1-5
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2019
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 1, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Other:
• nonpharmalogocial methods
neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure

Locations

Country	Name	City	State
Turkey	Adiyaman University	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Chronometer	Duration of crying and heel lancing procedure were recorded	2 minutes
Primary	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