The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
14. september 2026 oppdatert av: Kubra Nur Kabakcı Sarıdağ
Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications.
This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age).
A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier).
Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator.
Physiological impact (heart rate, oxygen saturation) and propagation time were recorded.
The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kubra Nur N KABAKCI SARIDAĞ, RN, MSc
- Telefonnummer: +905079149033
- E-post: kubranurkabakci@gmail.com
Studiesteder
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Ankara, Tyrkia (Türkiye)
- Rekruttering
- Etlik City Hospital
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Ta kontakt med:
- Kübra S Kabakcı Sarıdağ
- Telefonnummer: +90 5079149033
- E-post: kubranurkabakci@gmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Preterm infants with a gestational age between 32 and 36+6 weeks
- Written informed consent obtained from parents
Exclusion Criteria:
- Infants with serious medical conditions that may affect study parameters
- Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Gentle Human Touch
Gentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test.
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Before starting the procedure, the nurse performing the intervention will wear a clean gown and wash both hands and forearms with an antimicrobial agent for 3 minutes. The nurse's hand temperature will be measured with a digital thermometer prior to the intervention to ensure it is at an appropriate level. If the temperature is not suitable, both hands will be warmed under a radiant warmer until they reach 33-33.2 °C, and the intervention will begin once this temperature is achieved. During the intervention, the nurse will place the fingertips of one hand on the infant's eyebrow line with the palm resting on the top of the head, while the other hand will be positioned on the lower abdomen covering the waist and hips, maintaining this position for 15 minutes. |
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Eksperimentell: Environmental Modification
Eye mask and earmuffs will be applied 3-5 minutes before, during, and after the heel prick blood test.
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Infants assigned to the environmental modification group will receive an eye mask and neonatal earmuffs (Minimuffs) to reduce exposure to light and noise.
The eye mask is a soft, adjustable, and disposable phototherapy band designed to block external light stimuli.
The earmuffs are oval-shaped, foam-based neonatal ear protectors with hydrogel adhesive, designed to reduce noise levels by more than 50% and ensure safe single use.
Both interventions will be applied 3-5 minutes before, during, and for 3-5 minutes after venous blood sampling, for a total of approximately 15 minutes.
Standard care with a pacifier will also be provided according to unit practice.
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Ingen inngripen: Standard Care
Finger feeding will be provided before, during, and after the procedure, according to the unit routine.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Procedural Pain Score
Tidsramme: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
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The pain experienced during heel prick blood sampling will be assessed using the Premature Infant Pain Profile-Revised (PIPP-R) scale.
The scale ranges from 0 to 21 (for premature infants), with higher scores indicating greater pain intensity.
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5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
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Procedural Comfort Score
Tidsramme: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
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Comfort during heel prick blood sampling will be assessed using the COMFORTneo Scale.
The scale ranges from 7 to 35, with higher scores indicating a lower level of comfort.
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5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Crying Duration
Tidsramme: During and immediately after heel prick blood sampling
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Total duration of crying during heel prick blood sampling will be measured with a stopwatch and recorded in seconds.
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During and immediately after heel prick blood sampling
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Oxygen Saturation
Tidsramme: 5 minutes before, during, and 5 minutes after heel prick blood sampling
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Oxygen saturation levels will be monitored with pulse oximetry.
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5 minutes before, during, and 5 minutes after heel prick blood sampling
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
19. februar 2026
Først innsendt som oppfylte QC-kriteriene
15. juli 2026
Først lagt ut (Faktiske)
20. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KUBRAN-GHT-PREM-2025
Plan for individuelle deltakerdata (IPD)
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