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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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