Infant, Newborn, PainNCT05672303
Pain During Vaccine Administration
A study testing Palmar grasp reflex in people with Infant, Newborn, Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used. Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Pain
- What is being tested?
- Palmar grasp reflex
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Apr 2023
- 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 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 28-36 gestational week
- No congenital malformation
- follow up with a diagnosis of respiratory distress syndrome,
- receive oxygen support with a nasal cannula or tube,
- not receive mechanical ventilation support,
- no contraindications for hepatitis B vaccine administration,
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- stable vital signs before vaccination,
- not receive analgesic sedation treatment
- whose parents give verbal and written consent to participate in the study.
Who cannot join
- Infants of parents who did not give informed voluntary consent will not be included in the study.
- Decreased oxygen saturation levels
- Tachycardia just before the vaccine administration
- Invasive intervention in the right hand.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration
Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.
In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.
This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.
- Conditions
- Infant, Newborn, Pain
- Being tested
- Palmar grasp reflex
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmar grasp reflexBehavioural
The reflex can be stimulated by moving an object distally across the palm. In the study, at the beginning of the vaccine administration, the right hand of the infant will be moved distally along the palm with the researcher's index finger, thus providing reflex stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine procedure will be applied |
| Experimental | Experimental | Palmar grasp reflex will be stimulated with routine procedure. Receives: Behavioral: Palmar grasp reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level will be measured in the premature baby
PIPP-R Form: The PIPP scale, developed by Stevens et al. in 1996, is a validated assessment tool used to evaluate acute pain experienced by preterm infants during interventional procedures (Stevens et al., 1996). This scale was revised by Stevens et al. in 2014 (Stevens et al., 2014). The PIPP-R was adapted into Turkish in 2019 (Taplak, \& Bayat, 2019). PIPP-R consists of behavioral subscales such as frowning, squeezing eyes, nasolabial furrow, physiological and behavioral status including heart rate and SPO2, and contextual subscales such as gestational age.
Measured: 15 minutes
Secondary outcomes (1)
Crying time
Crying time will be evaluated in seconds with a coronometer.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, PainStudies 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
- 59 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
- NCT05672303
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/277
- Status last verified
- May 2024
- First submitted
- 3 Jan 2023
- Last updated
- 28 May 2024
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration
- ClinicalTrials.gov ID
- NCT05672303
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/277
- Conditions
- Infant, Newborn, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc Elif Simay KOÇ
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 5 Jan 2023 (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.
Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.
In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.
This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.
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 |
|---|---|---|
| Control | No intervention | –Routine procedure will be applied |
| Experimental | Experimental | Behavioral: Palmar grasp reflexPalmar grasp reflex will be stimulated with routine procedure. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 28-36 gestational week
- No congenital malformation
- follow up with a diagnosis of respiratory distress syndrome,
- receive oxygen support with a nasal cannula or tube,
- not receive mechanical ventilation support,
Key exclusion criteria (4 listed)
- Infants of parents who did not give informed voluntary consent will not be included in the study.
- Decreased oxygen saturation levels
- Tachycardia just before the vaccine administration
- Invasive intervention in the right hand.
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 reflexThe reflex can be stimulated by moving an object distally across the palm. In the study, at the beginning of the vaccine administration, the right hand of the infant will be moved distally along the palm with the researcher's index finger, thus providing reflex stimulation. | Behavioural | Experimental |
Primary outcome
pain level will be measured in the premature baby
Time frame: 15 minutes
PIPP-R Form: The PIPP scale, developed by Stevens et al. in 1996, is a validated assessment tool used to evaluate acute pain experienced by preterm infants during interventional procedures (Stevens et al., 1996). This scale was revised by Stevens et al. in 2014 (Stevens et al., 2014). The PIPP-R was adapted into Turkish in 2019 (Taplak, \& Bayat, 2019). PIPP-R consists of behavioral subscales such as frowning, squeezing eyes, nasolabial furrow, physiological and behavioral status including heart rate and SPO2, and contextual subscales such as gestational age.
1 secondary outcome
Crying time
Time frame: 15 minutes
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 28 May 2024.
- 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 in people with Infant, Newborn, Pain, 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 9 inclusion and 4 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 28 May 2024. 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?
pain level will be measured in the premature baby (time frame: 15 minutes). 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 28 May 2024.