Infant, PrematureNCT05857423
The Comparison of Gentle Human Touch's Effect by Mother and Nurse on Pain Level During Heel Blood Sampling in Preterm Infants
A study testing Gentle Human Touch in people with Infant, Premature, run by Istanbul University - Cerrahpasa.
Trial summary
This study is an experimental randomized controlled study conducted to compare the effect of gentle human touch applied by mother and nurse on pain level during heel blood sampling in preterm infant. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Gentle Human Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to 30 Dec 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 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 32 and 36 weeks,
- Birth weight 1200 gr or more,
- APGAR score more than 6 at 5 minute,
- No intracranial hemorrhage higher than Grade II,
- Must have a hemodynamic stability (infants receiving ventilator respiratory support, sepsis, cyanosis and heart disease are not included in the sampling),
- Not taking opiates and sedatives within 4 hour before heel lancing,
- No painful procedure was performed 1 hour ago before heel lancing,
Who cannot join
- Having a congenital anomalies,
- Having a skin disease,
- Receiving respiratory support with a mechanical ventilator,
- Having a surgical operation,
About this study
This study is an experimental randomized controlled study conducted to compare the effect of gentle human touch applied by mother and nurse on pain level during heel blood sampling in preterm infant. The population of the study consists of preterm infants who stay neonatal intensive care unit of state hospital and whose heels blood sampling will be collected. The number of samples for this study was determined as 40 preterm infants with theoretical power of 95%. This study will be started when the researcher informs the families of preterm infants about the research and receives written and oral consent. The preterm infants were divided into 2 groups of 20 preterm infants, including control group who are applied gentle human touch by nurses and the experimental group who are applied gentle human touch by mothers. In the study, the randomization of the sample group was performed through the website named www.randomizer.org. The researcher records physiological measurements (heart rate and oxygen saturation) and the NIPS score before heel lancing. The gentle human touch procedure will be applied to infants in both groups for 10 minutes and then blood will be drawn from the infants' heels. Intervention assessment (KTA, oxygen saturation, and NIPS) will be done after the preterm infant's heel is pricked. The time will be kept when the needle is pricked and the procedure time will be recorded when the blood collection is finished. The time will be kept as soon as the baby starts to cry and the crying time will be recorded when the crying ends. Evaluation of the NIPS/Neonatal Pain Scale will be done by the researcher and a nurse outside the study. Then, inta-rater reliability will be evaluated. After the blood collection, Gentle Human Touch application will be continued for 5 more minutes. At the end of this period, the heart rate, oxygen saturation and NIPS score will be evaluated again.
Read the detailed description
The hypotheses of the research are as follows:
- Ho: There is no significant difference between the effect of gentle human touch applied by the mother during heel prick procedure of preterm infants on neonatal pain level (NIPS: Neonatal Infant Pain Scale), heart rate, O2 saturation, and crying time, and the effect of gentle human touch applied by the nurse on pain level.
- H1: The NIPS score of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
- H2: The heart rate of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
- H3: The O2 saturation of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be higher than the neonates who received gentle human touch from the nurse.
- H4: The crying time of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be shorter than the neonates who received gentle human touch from the nurse.
- Conditions
- Infant, Premature
- Being tested
- Gentle Human Touch
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Human TouchOther
Gentle Human Touch procedure has 3 step as follows:
- Mother/nurse must wash their hands with antimicrobial soap for 3 minutes before starting Gentle Human Touch procedure.
- Next, mother/nurse must warm their hands.
- Mother/nurse must place their one hand on the infant's head and the other hand on the lower abdomen that covers the waist and hips of the preterm infant, for 15 minute.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Preterm infants who are applied gentle human touch by nurses Receives: Other: Gentle Human Touch |
| Experimental Group | Experimental | Preterm infants who are applied gentle human touch by mother Receives: Other: Gentle Human Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the Neonatal Infant Pain Scale (NIPS) at 5 minutes after the heel lancing
This scale, behavioral responses to pain as facial expression, crying, breathing pattern, arms, legs, and alertness are evaluated. The preterm infant get a score between 0-7 and is considered to have pain if it gets a score greater than 3.
Change=(5 minutes after score- baseline score)
Measured: Baseline and 5 minutes after the heel lancing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start10 May 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Avlac, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857423
- Sponsor's protocol ID
- IstanbulUCCansuAvlaç0000000001
- Status last verified
- May 2023
- First submitted
- 25 Mar 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Gentle Human Touch's Effect by Mother and Nurse on Pain Level During Heel Blood Sampling in Preterm Infants
- ClinicalTrials.gov ID
- NCT05857423
- Acronym / sponsor ID
- IstanbulUCCansuAvlaç0000000001
- Conditions
- Infant, Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 May 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.
This study is an experimental randomized controlled study conducted to compare the effect of gentle human touch applied by mother and nurse on pain level during heel blood sampling in preterm infant. The population of the study consists of preterm infants who stay neonatal intensive care unit of state hospital and whose heels blood sampling will be collected. The number of samples for this study was determined as 40 preterm infants with theoretical power of 95%. This study will be started when the researcher informs the families of preterm infants about the research and receives written and oral consent. The preterm infants were divided into 2 groups of 20 preterm infants, including control group who are applied gentle human touch by nurses and the experimental group who are applied gentle human touch by mothers. In the study, the randomization of the sample group was performed through the website named www.randomizer.org. The researcher records physiological measurements (heart rate and oxygen saturation) and the NIPS score before heel lancing. The gentle human touch procedure will be applied to infants in both groups for 10 minutes and then blood will be drawn from the infants' heels. Intervention assessment (KTA, oxygen saturation, and NIPS) will be done after the preterm infant's heel is pricked. The time will be kept when the needle is pricked and the procedure time will be recorded when the blood collection is finished. The time will be kept as soon as the baby starts to cry and the crying time will be recorded when the crying ends. Evaluation of the NIPS/Neonatal Pain Scale will be done by the researcher and a nurse outside the study. Then, inta-rater reliability will be evaluated. After the blood collection, Gentle Human Touch application will be continued for 5 more minutes. At the end of this period, the heart rate, oxygen saturation and NIPS score will be evaluated again.
Detailed description
The hypotheses of the research are as follows:
- Ho: There is no significant difference between the effect of gentle human touch applied by the mother during heel prick procedure of preterm infants on neonatal pain level (NIPS: Neonatal Infant Pain Scale), heart rate, O2 saturation, and crying time, and the effect of gentle human touch applied by the nurse on pain level.
- H1: The NIPS score of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
- H2: The heart rate of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
- H3: The O2 saturation of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be higher than the neonates who received gentle human touch from the nurse.
- H4: The crying time of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be shorter than the neonates who received gentle human touch from the nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Gentle Human TouchPreterm infants who are applied gentle human touch by nurses |
| Experimental Group | Experimental | Other: Gentle Human TouchPreterm infants who are applied gentle human touch by mother |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age between 32 and 36 weeks,
- Birth weight 1200 gr or more,
- APGAR score more than 6 at 5 minute,
- No intracranial hemorrhage higher than Grade II,
- Must have a hemodynamic stability (infants receiving ventilator respiratory support, sepsis, cyanosis and heart disease are not included in the sampling),
Key exclusion criteria (4 listed)
- Having a congenital anomalies,
- Having a skin disease,
- Receiving respiratory support with a mechanical ventilator,
- Having a surgical operation,
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 |
|---|---|---|
| Gentle Human TouchGentle Human Touch procedure has 3 step as follows: 1. Mother/nurse must wash their hands with antimicrobial soap for 3 minutes before starting Gentle Human Touch procedure. 2. Next, mother/nurse must warm their hands. 3. Mother/nurse must place their one hand on the infant's head and the other hand on the lower abdomen that covers the waist and hips of the preterm infant, for 15 minute. | Other | Control Group, Experimental Group |
Primary outcome
Change from baseline in pain on the Neonatal Infant Pain Scale (NIPS) at 5 minutes after the heel lancing
Time frame: Baseline and 5 minutes after the heel lancing
This scale, behavioral responses to pain as facial expression, crying, breathing pattern, arms, legs, and alertness are evaluated. The preterm infant get a score between 0-7 and is considered to have pain if it gets a score greater than 3. Change=(5 minutes after score- baseline score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Human Touch in people with Infant, Premature, run by Istanbul University - Cerrahpasa.
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 7 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: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change from baseline in pain on the Neonatal Infant Pain Scale (NIPS) at 5 minutes after the heel lancing (time frame: Baseline and 5 minutes after the heel lancing). 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 12 May 2023.