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

NCT05051267 | Completed

• 1 other identifier: 70904504/43
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Newborn

Keywords

Newborn; Pain; Mother's voice; White noise; Mother Embrace

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Physiological Parameters

  1 year

• Physiological Parameters

  1 year

• Physiological Parameters

  1 year

• Physiological Parameters

  1 year

Study Arms (6)

Routine Care Group

NO INTERVENTION

Before the application, the families will be informed by the researcher and the 'Informed Consent Form' will be signed. After the heel blood procedure, comfort will be provided with gentle touches. For ethical reasons, routine care will be provided when the baby cries.

Mothers Embrace

EXPERIMENTAL

A mothers embrace is one of the earliest and most common care events that mothers offer to their babies. Close physical contact between mother and baby during hugs can reduce stress by facilitating co-regulation of mother and baby. In a study conducted in Turkey, it was stated that holding the baby on the lap for pain relief in painful interventions is a practical and easy method.

Other: Non-Pharmacological Methods

White Noise

EXPERIMENTAL

Since white noise is a humming and continuous monotonous sound, it is similar to the sound in the womb (Balci, 2006). It will be explained that this sound is very similar to the sound that the baby hears in the mother's womb by making the white noise recordings listen to the mothers who will have their babies listen to white noise. by Orhan Osman; Dr. From the album 'Kolik', which was created by making use of the album 'The Happiest Baby' prepared by Harvery Karp, which consists only of uterus sounds; The song 'Don't Let Your Baby Cry, PT.2' will be played to babies (Karp, 2015). In addition, infants will be excluded from the study even though they meet the criteria, if they are not sedated, the procedure takes more than 2 minutes, the procedure is disrupted because someone enters the room loudly, or the mother changes the baby's position (Karakoç, \& Türker, 2014).

Other: Non-Pharmacological Methods

Mother's Voice

EXPERIMENTAL

Auditory responses, fetal age 26-28. It develops in the auditory cortex and brain stem in weeks (Eskandari, Keshavarz, \& Jahdi, 2010). Hearing is one of the first senses a fetus develops and is 24-33. can recognize and remember the mother's voice after weeks (Djordjevic, 2010 ). The fetus memorizes the musical characteristics of the mother's voice, like tone, by listening to it (Arabin, 2002). It is stated that newborns exposed to their own mother's voice have a lower heart rate, higher sucking rate, a more relaxed appearance, and less crying and body movements (Campbell-Yeo, Fernandes, \& Johnston, 2011).

Other: Non-Pharmacological Methods

Mothers Embrace and White Noise Applied Group

EXPERIMENTAL

One minute after the procedure, the baby's pain score will be evaluated. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the white noise will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to pre-procedural basal values. When it returns to basal values, the baby's pain score will be re-evaluated.

Other: Non-Pharmacological Methods

Mothers Embrace and Mother's Voice Group

EXPERIMENTAL

After the procedure, the baby will continue to listen to the baby who is in the mother's arms. One minute after the procedure, the baby's pain score will be evaluated and the HR and O2 values will be noted. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the mother's voice will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to basal values. When it returns to basal values, the baby's pain score will be re-evaluated.

Other: Non-Pharmacological Methods

Interventions

Non-Pharmacological Methods OTHER

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.

Mother's Voice; Mothers Embrace; Mothers Embrace and Mother's Voice Group; Mothers Embrace and White Noise Applied Group; White Noise

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns postnatal age is between 1-5 days,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Kepez, Antalya, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 22123399 BACKGROUND

• 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. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.

  PMID: 16580851 BACKGROUND

• 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.

  PMID: 32062050 BACKGROUND

• Hermann C, Hohmeister J, Demirakca 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.

  PMID: 17011707 BACKGROUND

• Kahraman A, Gumus 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.

  PMID: 32653359 BACKGROUND

• Karakoc A, Turker 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.

  PMID: 24559599 BACKGROUND

• 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.

  PMID: 27751753 BACKGROUND

• 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.

  PMID: 26685099 BACKGROUND

• 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.

  PMID: 23625100 BACKGROUND

• 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.

  PMID: 21772915 BACKGROUND

• 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. doi: 10.1097/00002508-199603000-00004.

  PMID: 8722730 BACKGROUND

• 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.

  PMID: 21028915 BACKGROUND

• 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.

  PMID: 25939641 BACKGROUND

• 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. doi: 10.1016/s0031-9384(98)00338-2.

  PMID: 10386907 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uğur Gül

  Akdeniz University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 21, 2021
• Study Start: March 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)