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

Not Applicable

Completed

• Conditions: Interventions Pain
• Interventions: Other: Control Grup; Other: Foot Reflexology Methods; Other: Acupressure methods

• Registration Number: NCT04643730
• Lead Sponsor: Eskisehir Osmangazi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-30
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Study First Submitted: 2020-10-10
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-19
• Last Update Submitted: 2020-11-19
• Study First Posted: 2020-11-25
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Grup	No pre-application was made to the babies in the control group as a routine procedure
Reflexology Group	Foot Reflexology Methods	Foot Reflexology was applied to the babies before heel lancing
Acupressure Group	Acupressure methods	Acupressure was applied to the babies before heel lancing

Primary Outcome Measures

Name	Time	Method
Pain levels of the newborns	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)	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).

Secondary Outcome Measures

Name	Time	Method
Changes in heart rates	2 Minutes	Recorded the changes in Heart rate of newborns (Having completed the 24th hour of the postnatal period) before (A pulse oximeter was attached to the infants two minutes before the procedure), during and after pain procedure
Percentage of crying during heel prick in healthy term neonates	During heel prick and immediately after intervention	Percentage of crying in 3 groups were applied during heel prick and immediately after intervention. Results are shown as mean.
Changes in oxygen saturation	2 Minutes	Recorded the changes in oxygen saturation (SpO2) of newborns (Having completed the 24th hour of the postnatal period) before (A pulse oximeter was attached to the infants two minutes before the procedure), during and after pain procedure

Trial Locations

Locations (1)

Afyonkarahisar Public Hospital; 🇹🇷 Afyonkarahisar, Turkey