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RecruitingNCT06415240Updated Aug 20, 2024

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

An interventional study of Facilitated Tucking and Gentle Human Touch in Non Pharmacological Pain Management, sponsored by Shifa Tameer-e-Millat University. Recruiting at 2 sites in Pakistan. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
1 Day to 28 Days
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non Pharmacological Pain Management

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Keywords

  • Non Pharmacological Pain Management
  • Neonates
  • Procedural Pain
03

In context

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's planned enrollment of 159 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

Shifa Tameer-e-Millat University is the lead sponsor of 27 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Documented birth asphyxia
  2. Congenital anomalies
  3. Neurological diagnosis,
  4. ventilated with paralysis
  5. Extremely premature newborns (Gestational age \< 28 weeks)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
159 participants (estimated)

Study arms

  • Experimental
    Facilitated Tucking

    A non pharmacological intervention to be implemented during arterial prick.

    Other: Facilitated Tucking

  • Experimental
    Gentle Human Touch

    A non pharmacological intervention to be implemented during arterial prick.

    Other: Gentle Human Touch

  • No intervention
    Usual Care

    Usual Care

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.

06

What researchers measure

Primary outcomes

  1. Neonatal Infant Pain Scale

    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

    Time frame: Before,During Arterial Prick and after three minutes

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Not intended

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Sep 2024, 4 months after the start.

Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 4 months is below that.

Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2024
First posted
May 16, 2024
StartActual
May 20, 2024
Primary completionEst.
Sep 30, 2024
CompletionEst.
Nov 30, 2024
Last update
Aug 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06415240
Lead sponsor
Shifa Tameer-e-Millat University
Responsible party
Nazma Hamid (Assistant Clinical Nurse Manager, Shifa International Hospital) — Principal investigator
First posted
May 16, 2024
Start date
May 20, 2024
Primary completion
Sep 30, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Aug 20, 2024

Study contacts

Nazma Hamid, MSN
Contact
nazmahamid07@gmail.com
03421547629
Nazma Hamid, MSN
principal investigator · Shifa Tameer E Millat Univesrity

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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