Interventions Pain Clinical Trial
Official title:
Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
| Verified date | November 2020 |
| Source | Eskisehir Osmangazi University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | March 30, 2018 |
| Est. primary completion date | March 30, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Afyonkarahisar Public Hospital | Afyonkarahisar |
| Lead Sponsor | Collaborator |
|---|---|
| Eskisehir Osmangazi University |
Turkey,
Açikgöz, A., Çigdem, Z., Yildiz, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11
Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19. — View Citation
Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 Açikgöz 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 (Açikgöz 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |