ClinicalTrials.gg
CompletedNCT05295147Updated Apr 22, 2022

Physiological Parameters and Crying Time in the Newborn Bath

An interventional study of Palmar Grasp Reflex Stimulation in Infant, Newborn, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-22.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
2 Days to 28 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Infant, Newborn
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 454 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Ineligible for immersion tub bathing
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Palmar Grasp Reflex Stimulation

    Other: Palmar Grasp Reflex Stimulation

  • No intervention
    Control Group

Interventions

  • OtherPalmar Grasp Reflex Stimulation

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

06

What researchers measure

Primary outcomes

  1. Body temperature in Celsius

    Time frame: 12 week

  2. Respiratory rate per minute

    Time frame: 12 week

  3. Pulse per minute

    Time frame: 12 week

  4. Oxygen saturation levels in %

    Time frame: 12 week

  5. Crying time in seconds

    Time frame: 12 week

07

Study locations

1 site
  • AtaturkU
    Yakutiye, Erzurum 25000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05295147
Lead sponsor
Ataturk University
Collaborators
MSc Elif Simay KOÇ
Responsible party
Türkan Kadiroğlu (Principal Investigator, Ataturk University) — Principal investigator
First posted
Mar 24, 2022
Start date
Dec 1, 2021
Primary completion
Mar 1, 2022
Completion
Mar 15, 2022
Last update
Apr 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion