- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295147
Physiological Parameters and Crying Time in the Newborn Bath
April 21, 2022 updated by: Türkan Kadiroğlu, Ataturk University
The Effect of Palmar Grasp Reflex Stimulation on Physiological Parameters and Crying Time in the Newborn Bath
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Erzurum
-
Yakuti̇ye, Erzurum, Turkey, 25000
- AtaturkU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 days to 4 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Palmar Grasp Reflex Stimulation
|
The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body temperature in Celsius
Time Frame: 12 week
|
12 week
|
|
Respiratory rate per minute
Time Frame: 12 week
|
12 week
|
|
Pulse per minute
Time Frame: 12 week
|
12 week
|
|
Oxygen saturation levels in %
Time Frame: 12 week
|
12 week
|
|
Crying time in seconds
Time Frame: 12 week
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
March 7, 2022
First Submitted That Met QC Criteria
March 15, 2022
First Posted (Actual)
March 24, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- B.30.2.ATA.0.01.00/51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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