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Completed

NCT Number: NCT06513897

The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters During Heel Lancing

Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University

Ankara, Turkey (Türkiye)

About this study

Neonatal heel prick blood collection is a common medical procedure performed to obtain blood samples from newborns for diagnostic purposes. Neonatal heel prick plays an important role in the diagnosis of genetic and metabolic diseases such as hypothyroidism and phenylketonuria. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Pain during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate the associated discomfort and reduce crying time. In this sense, there are studies on both heel prick instruments and interventions applied to the infant during heel prick. Non-pharmacological approaches such as acupressure and hugging are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. It is known that one of the most important determinants of attachment in the postnatal period is touch, hugging and skin-to-skin contact. The neonatal period is a critical developmental stage characterised by rapid physiological and neurological changes. It is thought that the sensitivity of newborns to pain and early painful experiences may have potential long-term effects. There are studies suggesting that painful procedures may be effective in mother-baby or father-baby attachment. While there are studies in the literature on mother's hug, no study on father's hug was found. Due to the role of the presence of fathers in paediatric pain management, the potential to provide emotional support, the father's hug as a form of comforting touch, contributing to the release of oxytocin, a hormone associated with attachment and stress reduction, and the emotional bond established through hugging may act as a buffer against distress associated with painful procedures and promote a sense of security and assurance in the infant, it was considered appropriate to use it in this study. Acupressure, derived from traditional Chinese medicine, involves applying manual pressure to specific points on the body to promote healing and relieve pain. Similarly, emotional support provided by a carer, such as a father, through cuddling is thought to have the potential to reduce stress and improve the infant's emotional well-being. In this study, investigators aimed to evaluate the effectiveness of acupressure and paternal hug interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a term newborn
  • A healthy newborn with its mother by its side
  • Not taking any analgesic/sedative medication within 24 hours
  • The baby has not undergone invasive procedures other than routine interventions

Exclusion criteria

  • Preterm-postterm newborn
  • Having a systemic disease
  • Taking analgesic/sedative medication in the last 24 hours
  • Invasive procedures other than routine interventions

Treatment and study plan

Acupressure

Other

Acupressure will be applied to the foreheads of the babies in this group starting two minutes before the heel prick. Acupressure application will be finished when heel prick blood collection is finished.

Father's Lap

Other

Infants in this group will be placed on the father's lap two minutes before heel prick blood collection. They will remain on the father's lap during the heel prick procedure.

Primary outcomes

  1. Pain Score

    Time frame: pre-intervention, immediately after the intervention

    Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain.

  2. Pulse value

    Time frame: pre-intervention, immediately after the intervention

    Pulse value will be assessed using the infant pulse oximeter.

  3. Crying time

    Time frame: During the intervention

    Crying time will be recorded throughout the procedure.

  4. Saturation value

    Time frame: pre-intervention, immediately after the intervention

    Saturation value will be assessed using the infant pulse oximeter.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Mersin University

Registry information

Official study title

The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters in Infants During Heel Lancing: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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