Infant, NewbornNCT05295147
Physiological Parameters and Crying Time in the Newborn Bath
A study testing Palmar Grasp Reflex Stimulation in people with Infant, Newborn, run by Ataturk University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 2 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- Palmar Grasp Reflex Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Ineligible for immersion tub bathing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infant, Newborn
- Being tested
- Palmar Grasp Reflex Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmar Grasp Reflex StimulationOther
The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.
| Study group | Role | What they receive |
|---|---|---|
| Palmar Grasp Reflex Stimulation | Experimental | Not described Receives: Other: Palmar Grasp Reflex Stimulation |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature in Celsius
Measured: 12 week
Respiratory rate per minute
Measured: 12 week
Pulse per minute
Measured: 12 week
Oxygen saturation levels in %
Measured: 12 week
Crying time in seconds
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Dec 2021
- Primary completion1 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- MSc Elif Simay KOÇ
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295147
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/51
- Status last verified
- Apr 2022
- First submitted
- 7 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Palmar Grasp Reflex Stimulation on Physiological Parameters and Crying Time in the Newborn Bath
- ClinicalTrials.gov ID
- NCT05295147
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/51
- Conditions
- Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc Elif Simay KOÇ
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palmar Grasp Reflex Stimulation | Experimental | Other: Palmar Grasp Reflex Stimulation |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Ineligible for immersion tub bathing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palmar Grasp Reflex StimulationThe palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers. | Other | Palmar Grasp Reflex Stimulation |
Primary outcome
Body temperature in Celsius
Time frame: 12 week
Respiratory rate per minute
Time frame: 12 week
Pulse per minute
Time frame: 12 week
Oxygen saturation levels in %
Time frame: 12 week
Crying time in seconds
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmar Grasp Reflex Stimulation in people with Infant, Newborn, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature in Celsius (time frame: 12 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.