| CTRI Number |
CTRI/2026/01/101573 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Non-pharmacological Interventions with Heel Warming on Pain During Heel Prick in Preterm Babies |
|
Scientific Title of Study
|
Efficacy and Safety of Occupational Therapy-Based Non-Pharmacological Interventions Combined with Heel Warming for Reducing Pain during Heel Lance in Preterm Neonates |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tamil M |
| Designation |
Post graduate Student MOT (Paediatrics) |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
No. 1, Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9384990449 |
| Fax |
|
| Email |
mtamil02111999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Raghuram P |
| Designation |
Head,Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) |
| Affiliation |
Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) |
| Address |
No. 1, Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9677073853 |
| Fax |
|
| Email |
raghurammot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Raghuram P |
| Designation |
Head,Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) |
| Affiliation |
Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) |
| Address |
No. 1, Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9677073853 |
| Fax |
|
| Email |
raghurammot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| The study is conducted using routine NICU resources without external funding or sponsorship. |
|
|
Primary Sponsor
|
| Name |
Tamil M |
| Address |
No. 1, Ramachandra Nagar, Porur, Chennai - 600 116 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Umamaheswari B |
Sri Ramachandra Institute of Higher Education and Research (SRIHER). |
No. 1, Ramachandra Nagar, Porur, Chennai - 600 116 Tamil Nadu,India
Chennai
TAMIL NADU |
9941853855
drumarajakumar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Swaddling and heel warming |
Swaddling will be performed 5 minutes before the heel lance and maintained throughout the procedure. The lower end of the swaddle will be unfolded to perform heel warming for 3-5 minutes, and then a heel lance will be performed.
|
| Intervention |
Group 2: NNS and Heel warming |
Non-nutritive sucking will be initiated by using mother finger or sterile cotton gauze dipped in expressed mother milk and maintained throughout the procedure.After 5 minutes of NNS, heel warming will be initiated to the neonates and the heel lance will be performed.
|
| Comparator Agent |
Group 3: Swaddling only (control group) |
Swaddling will be performed 5 minutes before the heel lance and maintained throughout the procedure. The lower end of the swaddle will be unfolded to perform the heel lance.
|
| Comparator Agent |
Group 4: NNS only (control group) |
Non-nutritive sucking will be initiated by using mother finger or sterile cotton gauze dipped in expressed mother milk and maintained throughout the procedure |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
32.00 Day(s) |
| Gender |
Both |
| Details |
Clinically stable preterm neonates with gestational age 30 to 36 weeks
Fed and calm 1 to 2 hours before the procedure
|
|
| ExclusionCriteria |
| Details |
Congenital anomalies affecting feeding or neurological status
Received analgesics or sedatives within the last 6 hours
Suspected coagulation disorder or severe illness
Receiving oxygen therapy and mechanical ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in procedural pain intensity during heel lance in preterm neonates, measured using a validated neonatal pain assessment scale (e.g., PIPP-R Before during and immediately after the procedure. |
Before during and immediately after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in heart rate and oxygen saturation, behavioral pain responses, and comparison of pain scores across intervention groups |
Before during and immediately after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| Date of Study Completion (India) |
15/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preterm neonates admitted to neonatal intensive care units (NICUs) are frequently exposed to painful procedures, with heel lance being one of the most commonly performed. Evidence shows that repeated unmanaged procedural pain in preterm infants is associated with altered pain sensitivity, physiological instability, and adverse neurodevelopmental outcomes. International guidelines, including those from the American Academy of Pediatrics and the World Health Organization, recommend the routine use of non-pharmacological interventions for procedural pain management in neonates.
Non-pharmacological strategies such as swaddling and non-nutritive sucking (NNS) have demonstrated efficacy in reducing behavioral and physiological pain responses during heel lance. Heel warming prior to capillary blood sampling has been shown to increase local blood flow, improve ease of sampling, and reduce procedural stress, while remaining safe when applied within recommended temperature limits. However, evidence on combined protocols integrating heel warming with structured developmental care interventions, particularly from an occupational therapy perspective, remains limited.
This prospective, multi-arm randomized controlled trial aims to evaluate the safety and efficacy of occupational therapy-based non-pharmacological interventions combined with heel warming in reducing pain during heel lance in preterm neonates (gestational age 30–36 weeks).
The study will be conducted in two phases: Phase 1, a pilot study assessing feasibility and safety; and Phase 2, a single-blind randomised controlled trial comparing four intervention groups: (1) swaddling with heel warming, (2) non-nutritive sucking with heel warming, (3) swaddling alone, and (4) non-nutritive sucking alone. Heel warming will be applied using a controlled commercial warming device at 38–40 °C for 3–5 minutes before heel lance.
Pain will be assessed using the Premature Infant Pain Profile-Revised (PIPP-R), a validated neonatal pain assessment tool. Physiological parameters (heart rate and oxygen saturation) and heel skin integrity will be monitored using the Neonatal Skin Condition Score (NSCS). Outcome assessors will be blinded to group allocation.
The findings of this study are expected to provide evidence for a safe, low-cost, and developmentally supportive pain-management protocol, strengthening the role of occupational therapy in neonatal procedural pain management in NICU settings |