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

NCT ID: NCT03906552

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2018-12-01

Brief Summary

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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

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

nonpharmalogocial methods

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

nonpharmalogocial methods

Intervention Type OTHER

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nonpharmalogocial methods

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adiyaman University Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tuba Koc Ozkan

Adiyaman University School of Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adiyaman University

Adıyaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/1-5

Identifier Type: -

Identifier Source: org_study_id

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