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

Study Overview
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Brief Summary
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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.

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

Conditions
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Interventions Pain

Intervention / Treatment
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* Other: Acupressure methods
* Other: Foot Reflexology Methods
* Other: Control Grup


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflexology Group<br>Foot Reflexology was applied to the babies before heel lancing | Other: Foot Reflexology Methods<br>* Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick<br>|
| Experimental: Acupressure Group<br>Acupressure was applied to the babies before heel lancing | Other: Acupressure methods<br>* 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<br>|
| Active Comparator: Control Group<br>No pre-application was made to the babies in the control group as a routine procedure | Other: Control Grup<br>* No pre-application was made to the babies in the control group as a routine procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in oxygen saturation | 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 Minutes | 
| Changes in heart rates | 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 | 2 Minutes | 
| Percentage of crying during heel prick in healthy term neonates | Percentage of crying in 3 groups were applied during heel prick and immediately after intervention. Results are shown as mean. | During heel prick and immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn,, pain,, heel lance,, foot reflexology,, acupressure,, nurse