NCT05295147

Brief Summary

Bathing is essential for maintaining and improving the health of the newborn. It has numerous beneficial effects, such as cleaning and protecting the skin, preventing infections, cleaning unwanted substances, regulating blood circulation and the respiratory system, regulating body temperature, relieving pain, providing comfort, and supporting the parent-infant bond. Although bathing has many benefits, it is a stressful experience for newborn babies. Research on the effects of bathing on babies has shown that babies experience behavioral difficulties during bathing, such as crying, restlessness, hiccups, yawning, tremors, body looseness, looseness of the extremities, facial looseness, opening of fingers, and grimacing. Bathing may also lead to some physiological responses, such as hypothermia, hypoxia, dyspnea, cyanosis, desaturation, and tachycardia.Therefore, this study aimed to determine the effect of palmar grasp reflex stimulation during neonatal bath on the physiological parameters and crying time of the newborn.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 7, 2022

Last Update Submit

April 21, 2022

Conditions

Infant, Newborn

Outcome Measures

Primary Outcomes (5)

  • Body temperature in Celsius

    12 week

  • Respiratory rate per minute

    12 week

  • Pulse per minute

    12 week

  • Oxygen saturation levels in %

    12 week

  • Crying time in seconds

    12 week

Study Arms (2)

Palmar Grasp Reflex Stimulation

EXPERIMENTAL
Other: Palmar Grasp Reflex Stimulation

Control Group

NO INTERVENTION

Interventions

Palmar Grasp Reflex StimulationOTHER

The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.

Palmar Grasp Reflex Stimulation

Eligibility Criteria

Age2 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least 24 hours after birth
  • have a gestational age over 36
  • not be asphyxiated
  • Feeding at least 1-3 hours before bathing
  • Not receiving analgesic sedation before bathing
  • Stable vital signs

You may not qualify if:

  • Ineligible for immersion tub bathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AtaturkU

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 24, 2022

Study Start

December 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 15, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)