| CTRI Number |
CTRI/2026/01/102203 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does a Crochet Octopus Help Reduce Stress in Preterm Babies |
|
Scientific Title of Study
|
Effect of Crochet Octopus on stress in Preterm Newborns A Randomized 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 |
Dr Shivangi Kachhwaha |
| Designation |
Senior Resident |
| Affiliation |
Sri Aurobindo Medical College and PG Institute Indore |
| Address |
Department of Pediatrics,Division of Neonatology
Sri Aurobindo Medical college and PG institute First floor NICU
Indore
MADHYA PRADESH
453555
India |
| Phone |
8770775484 |
| Fax |
|
| Email |
shivangikachhwaha166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav mogra |
| Designation |
Associate Professor |
| Affiliation |
Sri Aurobindo Medical College and PG Institute Indore |
| Address |
Department of Pediatrics,Division of Neonatology
Sri Aurobindo Medical college and PG institute First floor NICU
Indore
MADHYA PRADESH
453555
India |
| Phone |
9967375044 |
| Fax |
|
| Email |
drgauravmogra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivangi Kachhwaha |
| Designation |
Senior Resident |
| Affiliation |
Sri Aurobindo Medical College and PG Institute Indore |
| Address |
Department of Pediatrics,Division of Neonatology
Sri Aurobindo Medical college and PG institute First floor NICU
Indore
MADHYA PRADESH
453555
India |
| Phone |
9967375044 |
| Fax |
|
| Email |
shivangikachhwaha166@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Aurobindo Medical college and PG institute,Indore pincode 453555 Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Sri Aurobindo Medical college and PG institute |
| Address |
Indore Ujjain State Highway, near MR 10 Crossing, on Sanwer Road, Indore, Madhya Pradesh, with pincode 453555 |
| Type of Sponsor |
Other [Academic] |
|
|
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 Shivangi kachhwaha |
Sri Aurobindo Medical College and PG Institute Indore |
Department of Pediatrics,Division of Neonatology
Sri Aurobindo Medical college and PG institute First floor NICU
Indore–Ujjain State Highway, Bhawarsala, Sanwer Road, Indore
Indore
MADHYA PRADESH |
8770775484
shivangikachhwaha166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Aurobindo Institute of Medical Sciences, Indore |
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 TOY |
Stable preterm infants will be enrolled after taking written informed consent who are expected to stay for more than 7 days.
Enrolled neonates will be randomly assigned to either the intervention group(crochet octopus toy) or control group (routine care only) in a1:1 ratio using a computer-generated random sequence.
Allocation will be concealed using sequentially numbered, opaque, sealed envelopes which will be opened only after obtaining consent.
A toy made of firm crochet ,the stitches tightly closed with rows of crochet eyes and mouth sewn, without using paint, glue or plastic eyes.
The octopus body consist of 8 tentacles 20 to 22 centimeters long with the head measuring 8 to 10 centimeters.
The octopus material will be 100% Hypoallergenic cotton wool.
Before each use crochet octopus will be thoroughly cleaned and sterilized following hospital infection control guidelines.
Intervention group- Neonates in this group will receive a sterile, hand crocheted octopus toy, placed close to the infant in the radiant warmer from Day 0 to Day 7 minimum 12 hours per day. The used crochet octopus will be sent for autoclaving every 12 hours . Serum cortisol will be measured before intervention and Day 7 at morning 8 am . Pain score will be measured before intervention and Day 7 by Premature Infant Pain Profile- Revised (PIPP-R).
Control group –Neonates in this group will receive standard NICU care. Serum cortisol will be measured on Day 0 and Day 7 at morning 8 am. Pain score will be measured before Day 0and Day 7 by Premature Infant Pain Profile- Revised (PIPP-R).
All infants in both groups will receive standard NICU care.
Blinding-Due to the visible nature of the intervention, blinding of clinical staff and caregivers will not be possible. Blinded outcome assessment will be done, outcome assessor will be blind to the nature of intervention given to the patient. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
0.23 Year(s) |
| Gender |
Both |
| Details |
Growing Preterm infants less than 34 weeks of gestational age.
Hemodynamically stable.
Not on any respiratory support.
Free from any comorbidities.
Expected to stay for more than 7 days. |
|
| ExclusionCriteria |
| Details |
Major congenital anomalies.
Parental refusal .
Suspected or confirmed cortisol deficiency |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of a crochet octopus toy on stress in preterm infants using serum cortisol as a biomarker
To assess the effect of a crochet octopus toy in reducing pain in preterm infants |
Day 0 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of a crochet octopus toy in reducing pain in preterm infants |
Day 0 and Day 7 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 Applicable |
| 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
|
Growing preterm infants experience stress during routine NICU care. Soft comfort objects such as crochet octopus toys are increasingly used in neonatal units, but scientific evidence regarding their effect on stress in preterm infants is limited. This randomized controlled trial will evaluate whether the use of a sterile handmade crochet octopus toy placed near the infant reduces physiological stress measured by serum cortisol levels. The study will also assess the effect of the toy on pain response using the Premature Infant Pain Profile Revised score. Sixty stable preterm infants will be randomly assigned to either the intervention group receiving the crochet octopus toy or the control group receiving routine NICU care. Stress and pain outcomes will be measured on Day zero and Day seven. The findings of this study may help in understanding whether a simple low cost comfort intervention can support better physiological stability in preterm infants |