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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05295147
Other study ID # B.30.2.ATA.0.01.00/51
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date March 15, 2022

Study information

Verified date April 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date March 15, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: • Ineligible for immersion tub bathing

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Palmar Grasp Reflex Stimulation
The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.

Locations

Country Name City State
Turkey AtaturkU Yakuti?ye Erzurum

Sponsors (2)

Lead Sponsor Collaborator
Ataturk University MSc Elif Simay KOÇ

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body temperature in Celsius 12 week
Primary Respiratory rate per minute 12 week
Primary Pulse per minute 12 week
Primary Oxygen saturation levels in % 12 week
Primary Crying time in seconds 12 week
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