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

Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04643730
Enrollment
105
Registered
2020-11-25
Start date
2017-10-30
Completion date
2018-03-30
Last updated
2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interventions Pain

Keywords

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

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.

Interventions

OTHERAcupressure methods

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

OTHERFoot Reflexology Methods

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

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

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain levels of the newbornsBefore 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

MeasureTime frameDescription
Changes in oxygen saturation2 MinutesRecorded 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
Changes in heart rates2 MinutesRecorded 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 neonatesDuring heel prick and immediately after interventionPercentage of crying in 3 groups were applied during heel prick and immediately after intervention. Results are shown as mean.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026