Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates

Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06415240

Enrollment

159

Registered

2024-05-16

Start date

2024-05-20

Completion date

2024-11-30

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Pharmacological Pain Management

Keywords

Non Pharmacological Pain Management, Neonates, Procedural Pain

Brief summary

This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.

Detailed description

The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.

Interventions

OTHERFacilitated Tucking

Facilitated Tucking is a position to be adopted for pain relief in neonates.

OTHERGentle Human Touch

while gentle human touch is caressing on head for pain relief.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

As participants are neonates, they are not able to judge any intervention. Data is being collected by an independent data collector and pain scoring is also planned to be done by an independent Research Assistant. So, an investigator is masked.

Intervention model description

Randomized Control Trial

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Neonatal Infant Pain Scale	Before,During Arterial Prick and after three minutes	scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome

Countries

Pakistan

Contacts

Primary ContactNazma Hamid, MSN

nazmahamid07@gmail.com03421547629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026