| CTRI Number |
CTRI/2026/01/100101 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Whether Crochet Octopus Toys Help Ease Pain in Preterm Newborns During IV Placement |
|
Scientific Title of Study
|
Crochet Octopus Therapy as a Non-Pharmacological Pain Reducing Measure During Intra Venous Cannulation in Moderate Preterm and Late Preterm: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugapandi |
| Designation |
Post graduate student |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Maharaja Agrasen Medical College Agroha
NH-10, VPO- Agroha, District-Hisar
Hisar HARYANA 125047 India |
| Phone |
8220292856 |
| Fax |
|
| Email |
dr.mpandimbbs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Surendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Room no 91, Pediatric OPD
Maharaja Agrasen Medical College Agroha
NH-10, VPO- Agroha, District-Hisar
Hisar HARYANA 125047 India |
| Phone |
7014197954 |
| Fax |
|
| Email |
drsgodara2003@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Murugapandi |
| Designation |
Post graduate student |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Maharaja Agrasen Medical College Agroha
NH-10, VPO- Agroha, District-Hisar
Hisar HARYANA 125047 India |
| Phone |
8220292856 |
| Fax |
|
| Email |
dr.mpandimbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College Agroha
district Hisar
Haryana 125047
India |
|
|
Primary Sponsor
|
| Name |
Maharaja Agarsen Medical College |
| Address |
Maharaja Agrasen Medical college Agroha
NH-10 VPO Agroha, District-Hisar 125047
Haryana
India
|
| Type of Sponsor |
Private medical college |
|
|
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 Surendra Kumar |
Maharaja Agrasen Medical College Agroha |
Room no 90,
pediatric OPD, Block A,
Maharaja Agrasen Medical College Agroha
NH-10 VPO Agroha, district-Hisar 125047
Harayana
India
Hisar HARYANA |
7014197954
drsgodara2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research, Maharaja Agrasen Medical College Agroha |
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 |
Crochet Octopus Therapy |
one octopus will be kept along with the baby in cradle as well as during KMC atleast 24 hours prior to the iv cannula insertion and PIPP score will be done. |
| Comparator Agent |
Standard neonatal care |
Standard neonatal care will be given to the premature neonate and PIPP score will be done after iv cannula insertion. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Day(s) |
| Gender |
Both |
| Details |
Who gives consent
Hemodynamically stable Neonate receiving KMC and requiring IV cannulation for medical care
Gestational age 32 weeks to 36 weeks and 6 days
Chronological age up to 2 weeks
|
|
| ExclusionCriteria |
| Details |
Sick neonate
Any congenital Anomalies or neurological impairments
Any analgesic before the intervention.
Critical illness requiring mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PIPP score and its parameters (Behavioral state, facial expressions, heart rate changes, oxygen saturation, and gestational age) |
10 Seconds Before and After Canula Insertion.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of cry after cannula insertion |
10 seconds after Canula Insertion |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized controlled trial aims to evaluate the effect of Crochet Octopus Therapy (COT) on pain response during IV cannulation in newborns. Eligible neonates admitted to the NICU will be enrolled after obtaining written informed consent from parents. Participants will be randomly allocated into two groups using a computer-generated randomization table, with allocation concealment ensured via the SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes) method.In the intervention group, neonates will receive Kangaroo Mother Care (KMC) while holding a crochet octopus infused with the mother’s scent. The octopus will remain with the baby in the cradle after each KMC session. This therapy will be continued for at least 24 hours before IV cannulation.The control group will receive standard care without any additional comfort measures before IV cannulation. In both groups, IV cannulation will be performed on the dorsum of the hand using the same brand and size of standard IV cannula by the principal investigator to maintain uniformity.A video of the procedure will be recorded for pain assessment, beginning 30 seconds before and continuing for 30 seconds after the cannulation or until the baby stops crying. NICU environmental conditions will be maintained between 25–28°C with noise levels below 35–40 decibels. Behavioral state, heart rate, and oxygen saturation will be recorded 30 seconds before and after the procedure. Pain will be assessed using video-based scoring post-procedure. |