NCT06214104

Brief Summary

It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. In addition, considering that by reducing the pain of newborns, their comfort will increase, mother-baby bonding will be greater, the newborn's adaptation to the outside world will increase, and sensory neural development will be positively affected. It is important for shaping. When the literature was examined, no study was found that examined the effect of the acupressure therapy method applied during heel blood collection of newborns and the effect of the fetal position on pain together. Accordingly, our study aimed to investigate the effects of these two important methods on pain and physiological parameters in newborns.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 10, 2024

Last Update Submit

January 10, 2024

Conditions

Keywords

Newborn, heels lancet, acupressure, fetal position

Outcome Measures

Primary Outcomes (1)

  • Neonatal Infant Pain Scale:NIPS

    It is a scale whose validity and reliability was established by Lawrence in 1993 for preterm and term babies and is used to evaluate the pain experienced by the newborn until the 6th week. It was developed to evaluate the behavioral pain responses of newborn babies 2 minutes before invasive procedures, 5 minutes during the procedure, and 3 minutes after the procedure.

    5 month

Study Arms (3)

acupressure

EXPERIMENTAL

Acupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds.

Behavioral: Acupressur

fetal position

EXPERIMENTAL

The fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline.

Behavioral: Acupressur

Control group

NO INTERVENTION

no intervention

Interventions

AcupressurBEHAVIORAL

Acupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds.The fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline.

Also known as: fetal position
acupressurefetal position

Eligibility Criteria

Age1 Week - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Birth week 38-40,
  • Within the first fifteen days of postnatal
  • Birth weight is 2500-4000 grams,
  • whose general condition is stable,
  • He is with his mother and is literate,
  • Mothers and newborns who agreed to participate in the research.

You may not qualify if:

  • In need of oxygen support,
  • Fed by orogastric tube,
  • In need of parenteral nutrition,
  • Receiving analgesic treatment,
  • Having physical, metabolic and genetic diseases,
  • Before the procedure, the Neonatal Infant Pain Scale (NIPS) score is ≥ 3 and above,
  • Newborns who were hospitalized in the neonatal intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 90, Cyprus

Location

Related Publications (2)

  • Lemus-Varela Mde L, Sola A, Golombek S, Baquero H, Borbonet D, Davila-Aliaga C, Del Moral T, Lara-Flores G, Lima-Rogel MV, Neira-Safi F, Natta D, Oviedo-Barrantes A, Rodriguez S; Consenso Clinico de Dolor y Estres Neonatal, de la Sociedad Iberoamericana de Neonatologia (SIBEN). [Consensus on the diagnostic and therapeutic approach to pain and stress in the newborn]. Rev Panam Salud Publica. 2014 Nov;36(5):348-54. Spanish.

  • Yilmaz D, Inal S. Effects of three different methods used during heel lance procedures on pain level in term neonates. Jpn J Nurs Sci. 2020 Oct;17(4):e12338. doi: 10.1111/jjns.12338. Epub 2020 Apr 2.

Study Officials

  • Arzu Abic, 1

    Eastern Mediterranean University

    STUDY DIRECTOR

Central Study Contacts

Gizem Oran Duzenli, 1

CONTACT

Gizem Oran Düzenli, 1

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, ICF, CSR

Locations