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Completed

NCT Number: NCT04643730

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

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.

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Key information

Conditions

Interventions Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Public Hospital

Afyonkarahisar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

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

Control Grup

Other

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

Primary outcomes

  1. Pain levels of the newborns

    Time frame: 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 outcomes

  1. Changes in oxygen saturation

    Time frame: 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

  2. Changes in heart rates

    Time frame: 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

  3. Percentage of crying during heel prick in healthy term neonates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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