Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Pain levels of the newborns
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 24 Hours to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- Changes in heart rates(2 Minutes)
- Percentage of crying during heel prick in healthy term neonates(During heel prick and immediately after intervention)
- Changes in oxygen saturation(2 Minutes)
Investigators
Ayşe Özge DENİZ
Principal Investigator
Eskisehir Osmangazi University