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

NCT06513897 | Completed

• 1 other identifier: Heel Lancing
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant Development; Nurse's Role; Pain, Acute

Keywords

acupressure; heel lancing; infant; father's lap

Outcome Measures

Primary Outcomes (4)

• Pain Score

  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.

  pre-intervention, immediately after the intervention

• Pulse value

  Pulse value will be assessed using the infant pulse oximeter.

  pre-intervention, immediately after the intervention

• Crying time

  Crying time will be recorded throughout the procedure.

  During the intervention

• Saturation value

  Saturation value will be assessed using the infant pulse oximeter.

  pre-intervention, immediately after the intervention

Study Arms (3)

Acupressure

EXPERIMENTAL

Other: Acupressure

Paternal Holding

EXPERIMENTAL

Other: Father's Lap

Control

NO INTERVENTION

Interventions

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.

Acupressure

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.

Paternal Holding

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead
• Mersin University: collaborator

Study Sites (1)

Başkent University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.

  PMID: 33520895 BACKGROUND

• Devi R, Priyadarshi M, Singh P, Chaurasia S, Basu S. Neonatal Pain Response to Various Heel Prick Devices: A Randomized Controlled Trial. Indian Pediatr. 2023 Nov 15;60(11):893-898. Epub 2023 Jun 21.

  PMID: 37551876 BACKGROUND

• Adeli M, Aradmehr M. A comparative study of maternal-neonate abdominal and kangaroo (skin-to-skin) skin contact immediately after birth on maternal attachment behaviors up to 2 months. J Educ Health Promot. 2018 Mar 1;7:42. doi: 10.4103/jehp.jehp_46_16. eCollection 2018.

  PMID: 29619393 BACKGROUND

• Abraham E, Hendler T, Shapira-Lichter I, Kanat-Maymon Y, Zagoory-Sharon O, Feldman R. Father's brain is sensitive to childcare experiences. Proc Natl Acad Sci U S A. 2014 Jul 8;111(27):9792-7. doi: 10.1073/pnas.1402569111. Epub 2014 May 27.

  PMID: 24912146 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 22, 2024
• Study Start: August 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)