The Effects on Pain of Acupressure and Foot Reflexology Before Heel Lancing in Newborns

NCT04643730 | Completed

• 1 other identifier: Ayşe Özge DENİZ
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.

Conditions

Interventions Pain

Keywords

Newborn,; pain,; heel lance,; foot reflexology,; acupressure,; nurse

Outcome Measures

Primary Outcomes (1)

• Pain levels of the newborns

  The N-PASS was developed by Hummel et al. in 2003 to be used in all full-term and preterm neonates. The scale was revised by Hummel on October 2, 2009 and adapted to Turkish by Açıkgöz et al. in 2011 The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.779 for preintervention and 0.917 for postintervention (Açıkgöz et al., 2017). The N-PASS consists of five sub-dimensions: crying and irritability, behavior-state, facial expression, extremities tone, and vital signs. The sub-dimension of vital signs was evaluated according to infants' heart rates and oxygen saturation values. The total pain score that can be obtained from the scale ranges between 0 and +10. A higher score indicates that the severity of pain is high. The goal of pain therapy is to keep the score at or below 3 (Hummel et al., 2008; Hummel et al., 2010).

  Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)

Secondary Outcomes (3)

• Changes in oxygen saturation

  2 Minutes

• Changes in heart rates

  2 Minutes

• Percentage of crying during heel prick in healthy term neonates

  During heel prick and immediately after intervention

Study Arms (3)

Reflexology Group

EXPERIMENTAL

Foot Reflexology was applied to the babies before heel lancing

Other: Foot Reflexology Methods

Acupressure Group

EXPERIMENTAL

Acupressure was applied to the babies before heel lancing

Other: Acupressure methods

Control Group

ACTIVE COMPARATOR

No pre-application was made to the babies in the control group as a routine procedure

Other: Control Grup

Interventions

Acupressure methods OTHER

Acupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick

Acupressure Group

Foot Reflexology Methods OTHER

Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick

Reflexology Group

Control Grup OTHER

No pre-application was made to the babies in the control group as a routine procedure.

Control Group

Eligibility Criteria

• Age: 24 Hours+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being born by cesarean section,
• Being a term newborn,
• Being completed the 24th hour of the postnatal period,
• Staying with birth mother,
• Being fed in the last half hour before the procedure,
• Having a heel prick performed by the same nurse,
• Giving blood on the first try (because pain level may change on the second try),
• Having a mother who gave written informed consent

You may not qualify if:

• Having no health problem,
• Being underwent more than 2 invasive interventions,
• Receiving an analgesic/sedative drug in the 8 hours before the application.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Afyonkarahisar Public Hospital

Afyonkarahisar, Turkey (Türkiye)

Location

Related Publications (4)

• Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.

  PMID: 18165830 BACKGROUND

• Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.

  PMID: 19924132 BACKGROUND

• Açıkgöz, A., Çiğdem, Z., Yıldız, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11

  BACKGROUND

• Deniz AO, Acikgoz A. A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates. Clin Nurs Res. 2023 Feb;32(2):306-312. doi: 10.1177/10547738211061815. Epub 2021 Dec 26.

  PMID: 34955035 DERIVED

MeSH Terms

Conditions

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: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: November 25, 2020
• Study Start: October 30, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)