Evaluation of the Effectiveness of Non-pharmacological Methods During Heel Blood Collection

Infant, Newborn Clinical Trial

Official title:

Evaluation of the Effectiveness of Mother's Voice, Mothers Embrace and White Noise Methods During Heel Blood Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051267
• Other study ID #: 70904504/43
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: April 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are cheap, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.

Description:

Pain is known to affect individuals of all ages. However, until the 1980s, it was widely believed that newborns were inadequate in perceiving and interpreting pain because their nervous system was not fully developed. Studies conducted after these years have shown that the fetus has all the anatomical structures and functions of the peripheral and central nervous system necessary to perceive and interpret pain from the 20th week. After this information, this issue started to be given more importance in newborns. The most important reason for this is that term and preterm newborns staying in neonatal units experience pain for numerous and very different reasons.

Heel blood sampling, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. Heel blood collection is more painful than venous blood collection, squeezing is another factor that causes pain. There is not enough data on the chronicity of pain after these procedures. However, the inability to control pain in newborns followed for a long time in health centers increases the risk of chronic pain.

It has been observed that the pain sensitivity of babies who were followed up in the neonatal period and exposed to painful procedures changed in the next period. Therefore, it is very important to measure the infant's perception of pain in order to investigate the causes, mechanisms, and effects of pain. The pain response is very difficult to understand because newborns cannot express themselves verbally. Observation of hormonal, behavioral, and metabolic changes in the body due to pain provides data on the level of response to pain and the effectiveness of treatment. Evaluation of the pain response in the newborn is performed to reveal the pain state, to determine the level of pain, and to understand whether there is a need for intervention. In the routine operation of health centers, it is necessary to give due importance to the evaluation of pain response. It is important to observe the pain conditions as well as the basic vital functions of babies. It has been shown that repetitive heel blood sampling increases sensitivity to pain and decreases the pain threshold. In the light of these findings, it is thought that the heel puncture procedure to collect blood from the heel in the newborn period will have a negative effect on the pain response of the baby in the long term. Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are inexpensive, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study in order to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Days

Eligibility

Inclusion Criteria:

• Newborns postnatal age is between 1-5 days,

• 37-42. newborns born between gestational weeks,

• Newborns are healthy,

• Babies of mothers without diabetes,

• Newborns were not given any opioid and non-opioid drugs before the application,

• Newborns have been fed at least 30 minutes ago,

• Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included.

• Mothers can speak and understand Turkish,

• Babies of mothers accepted to participate in the study and written consent form was obtained from them will be included in the study.

Exclusion Criteria:

• Connected to mechanical ventilator,

• Having a neurological disorder,

• Congenital anomaly,

• Having hyperglycemia,

• Having undergone a surgical procedure,

• The baby of a mother is addicted to drugs,

• If the lancet cannot be inserted and removed at once, the baby will be excluded from the study.

• Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby.

Related Conditions & MeSH terms

• Infant, Newborn

Intervention

Other:
• Non-Pharmacological Methods
All of the applications that increase the effectiveness of drugs when used together with analgesics and provide the elimination of pain by releasing our body's natural morphine and endorphins without the use of analgesics are called non-pharmacological treatment.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Kepez	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

Ahmadi M, Toghyani R, Shahidi S, Izadi M, Merasi MR, Agdak P, Meshkaty M, Nikkhahfard M. The study of Prevalence of Antigen HBs Positive and High-risk Behaviors in Pregnant Women Referring to Urban Health Centers of Isfahan Province in 2009. Iran J Nurs Midwifery Res. 2011 Winter;16(1):1-8. — View Citation

Anand KJ, Coskun V, Thrivikraman KV, Nemeroff CB, Plotsky PM. Long-term behavioral effects of repetitive pain in neonatal rat pups. Physiol Behav. 1999 Jun;66(4):627-37. — View Citation

Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24. — View Citation

Campbell-Yeo M, Fernandes A, Johnston C. Procedural pain management for neonates using nonpharmacological strategies: part 2: mother-driven interventions. Adv Neonatal Care. 2011 Oct;11(5):312-8; quiz pg 319-20. doi: 10.1097/ANC.0b013e318229aa76. Review. — View Citation

Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. Epub 2006 Apr 3. Review. — View Citation

Hermann C, Hohmeister J, Demirakça S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006 Dec 5;125(3):278-285. doi: 10.1016/j.pain.2006.08.026. Epub 2006 Oct 2. — View Citation

Kahraman A, Gümüs M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9. — View Citation

Karakoç A, Türker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20. — View Citation

Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15. — View Citation

Leng HY, Zheng XL, Zhang XH, He HY, Tu GF, Fu Q, Shi SN, Yan L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur J Pain. 2016 Jul;20(6):989-97. doi: 10.1002/ejp.824. Epub 2015 Dec 18. — View Citation

Neu M, Robinson J, Schmiege SJ. Influence of holding practice on preterm infant development. MCN Am J Matern Child Nurs. 2013 May-Jun;38(3):136-43. doi: 10.1097/NMC.0b013e31827ca68c. — View Citation

Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. — View Citation

Walter-Nicolet E, Annequin D, Biran V, Mitanchez D, Tourniaire B. Pain management in newborns: from prevention to treatment. Paediatr Drugs. 2010 Dec 1;12(6):353-65. doi: 10.2165/11318900-000000000-00000. Review. — View Citation

Yin T, Yang L, Lee TY, Li CC, Hua YM, Liaw JJ. Development of atraumatic heel-stick procedures by combined treatment with non-nutritive sucking, oral sucrose, and facilitated tucking: a randomised, controlled trial. Int J Nurs Stud. 2015 Aug;52(8):1288-99. doi: 10.1016/j.ijnurstu.2015.04.012. Epub 2015 Apr 23. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Results	Premature Infant Pain Profile Scale (PIPP); PIPP assesses pain with seven indicators. these; three behavioral (forehead wrinkling, squinting eyes, and widening of the nose wings), two physiological (heart rate and oxygen saturation), and two contextual (week of gestation and sleep/wake status) variables (Stevens et al., 1996). Within the scope of the PIPP scale; gestational week, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting eyes, and nose There are 7 items such as expansion on the wings. Each item; is scored as 0, 1, 2, and 3 from best to worst. Premature Infant Pain Profile Scale; Pain is considered mild between 0-6 points, moderate between 7-12 points, and severe between 13-21 points.	1 year
Primary	Pain Results	Neonatal Infant Pain Scale (NIPS); NIPS was developed to assess acute pain. It was developed by Lawrence et al. in 1993. Scoring in NIPS is made according to six categories. These; facial expression, crying, breathing pattern, arms, legs, and alertness. Crying category, three separate points (0-1-2) while others are evaluated with two separate points (0-1). The total score varies between 0-7. The lowest score is "0", while the most severe pain score is "7".; Lawrence, J., Alcock, D., McGrath, P., Kay, J., MacMurray, S., & Dulberry, C. The development of a tool to assess neonatal pain. 1993; 2(6), 59-66	1 year
Secondary	Physiological Parameters	Oxygen saturation Oxygen values of the newborn before, during and after the procedure	1 year
Secondary	Physiological Parameters	Crying Time The baby's crying time will be noted after receiving heel blood.	1 year
Secondary	Physiological Parameters	Heart Rate Peak Values will be noted by the researcher 1 minute before the procedure, during the heel blood procedure and 1 minute after the procedure.	1 year
Secondary	Physiological Parameters	Basal Values Time	1 year