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Triple Combination vs. Breastfeeding (Tetanalgesia) for Neonatal Pain Relief

NCT07777432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-08-20

No results posted yet for this study

Summary

This randomized clinical trial evaluated whether a non-pharmacological Triple Combination of expressed breast milk, sucking, and facilitated tucking reduced pain during heel prick in healthy term newborns compared with Breastfeeding (Tetanalgesia). The study included healthy term newborns with a gestational age of 37 weeks or more whose parents provided informed consent in the maternity unit of Hospital Comarcal de Vinaròs, Spain. Pain and response to the procedure were assessed by comparing the two groups, and two investigators who were not involved in data collection independently reviewed the video recordings to assign pain scores.

Conditions

  • PAIN
  • PAIN MANAGEMENT

Interventions

PROCEDURE

Triple Combination

Triple Combination intervention administered during heel prick.

PROCEDURE

Breastfeeding (Tetanalgesia)

Breastfeeding (Tetanalgesia) intervention administered during heel prick.

Sponsors & Collaborators

  • Universitat Jaume I

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
47 Hours
Max Age
52 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-03-22
Completion
2023-03-22

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777432 on ClinicalTrials.gov