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Effect of Reflexology on Pain Management in Newborns

NCT05235893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-03-10

No results posted yet for this study

Summary

Introduction: Approximately 10-14 painful procedures per day are performed in preterm and term infants during the hospital stay in the first week. The investigators aimed to determine the effect of reflexology being applied to the sole during painful procedures on pain perception, behavioral responses, and physiological changes in newborns compared with other non-pharmacological methods.

Material and Method: This study was planned as a randomized controlled trial in term infants being followed up in the Neonatal Intensive Care Unit (NICU) and maternity ward. To reduce pain during attempts to collect venous blood or heel lance which are routinely applied to term newborns before discharge; reflexology on the soles of the foot, 24% sucrose solution, kangaroo care, listening to classical music were applied to the babies and were compared to those who did not have any analgesic method.

Conditions

  • Pain, Procedural
  • Pain, Acute
  • Analgesia

Interventions

PROCEDURE

Reflexology

Reflexology was applied to soles of the babies in the second study group during 5-7 minutes, three minutes before the painful procedure was started by a physiotherapist, certificated in reflexology.

PROCEDURE

Sucrose %24

The newborns who were given one ml of a single-use 24% concentration of sucrose solution in the form of ready to use preparations

PROCEDURE

Kangaroo care

The newborns who were placed on the mother's lap for 3-5 minutes before the painful intervention and kangaroo care was applied

PROCEDURE

Music

Newborns who were exposed to the recorded "Deep Sleep" track from "Bedtime Mozart: Classical Lullabies for Babies" music

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Mahmut Caner US, MD · Esenler Maternity and Child Health Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-03-30
Completion
2020-05-30

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT05235893 on ClinicalTrials.gov