Effect of Tucking and Touch on Pain in Newborns
Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit
This study is testing if gentle holding and touch can help reduce pain in newborns during medical procedures like blood tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Shifa Tameer-e-Millat University Academic / other |
| Locations | 2 sites (Islamabad and 1 other locations) |
| Trial ID | NCT06415240 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of two non-pharmacological interventions, facilitated tucking and gentle human touch, on procedural pain experienced by neonates undergoing arterial prick procedures. The study employs a randomized control design, utilizing the Neonatal Infant Pain Scale for pain assessment. Data collection involves demographic recording and video analysis for objective pain scoring by an independent research assistant. The aim is to enhance pain management strategies for vulnerable neonate populations.
Who should consider this trial
Good fit: Ideal candidates include term and preterm neonates admitted to the Neonatal Intensive Care Unit who are undergoing their first arterial prick.
Not a fit: Patients with documented birth asphyxia, congenital anomalies, neurological diagnoses, or those who are extremely premature may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-drug methods to alleviate procedural pain in neonates.
How similar studies have performed: Other studies have shown promising results with non-pharmacological pain management techniques in neonates, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Both term and preterm neonates. 2. APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes 3. Admitted to the Neonatal Intensive Care Unit 4. Undergoing arterial prick for the first time. Exclusion Criteria: 1. Documented birth asphyxia 2. Congenital anomalies 3. Neurological diagnosis, 4. ventilated with paralysis 5. Extremely premature newborns (Gestational age \< 28 weeks)
Where this trial is running
Islamabad and 1 other locations
- Pakistan Institute of Medical Sciences — Islamabad, Pakistan (Recruiting)
- Shifa Tameer E Millat University — Islamabad, Pakistan (Not_yet_recruiting)
Study contacts
- Principal investigator: Nazma Hamid, MSN — Shifa Tameer E Millat Univesrity
- Study coordinator: Nazma Hamid, MSN
- Email: nazmahamid07@gmail.com
- Phone: 03421547629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.