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CTRI Number  CTRI/2025/07/090148 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [educational intervention]  
Study Design  Single Arm Study 
Public Title of Study   Influence of crochet training(amigurumi) on the emotional wellbeing of childhood cancer caregivers 
Scientific Title of Study   Influence of Amigurumi on the emotional wellbeing of childhood cancer caregivers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ann Thomas 
Designation  PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  official address Dept of design Division Manipal school of architecture Room no SF 02

Udupi
KARNATAKA
576104
India 
Phone  9022141197  
Fax    
Email  ann.dodmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Resmi G 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  official address Dept of design Division Manipal school of architecture Room No A-29

Udupi
KARNATAKA
576104
India 
Phone  9022141197  
Fax    
Email  resmi.g@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ann Thomas 
Designation  PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  official address Dept of design Division Manipal school of architecture Room no SF 02

Udupi
KARNATAKA
576104
India 
Phone  9022141197  
Fax    
Email  ann.dodmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education city Manipal state Karnataka India Pincode 673310  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, Manipal, Karnataka, India pincode 673310 
Type of Sponsor  Other [Academic Institute] 
 
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 
Ann Thomas  Kasturba Medical college Manipal  Department of hematology and oncology Division Accesslife Room no Banglow 30
Udupi
KARNATAKA 
9022141197

ann.dodmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Intitutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caregiver s of children with cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  educational trainning  a skill development programme in the art of amigurumi which is the Japenese art of toy making will be conducted for the mothers of children with cancer and the trainning will be assessed through a mixed method approach 
Comparator Agent  Not Aplicable  Not aplicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details 
Primary childhood cancer caregivers
Residing in Access Life Assistance Foundation
Residing for more than a month  
 
ExclusionCriteria 
Details  Visiting relatives and friends, siblings

Loss or fracture of finger or hand.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
skill development
emotional upliftment 
Week 0:Baseline that is before the training
Week 16: after the training (around 16 sessions)

Quantitative assessment  
 
Secondary Outcome  
Outcome  TimePoints 
Theoretical knowledge advancement  Week 0 & Week 16: Quantitative Data Collection
Week 20: Qualitative Data Collection
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Title of the project  Influence of amigurumi on the emotional wellbeing of childhood cancer caregivers

Type of Study   educational intervention

Aim The aim of this research is to explore the benefit of amigurumi training on the emotional wellbeing of childhood cancer caregivers

 Objectives

Objective 1 To design a customized Amigurumi module for childhood cancer caregivers

Objective 2 To explore the benefit of Amigurumi training among childhood cancer caregivers.

 Objective 3 To assess the experiences of participating in Amigurumi training on childhood cancer caregivers

 

Departments involved

 Recruitment site Accesslife Manipal

Coordinating departments 

Department of Pediatric Hematology and Oncology KMC Manipal

 Department of Design MSAP Manipal

 Department of Occupation Therapy MCHP Manipal

Study period 2years

Sample size

Quantitative 40 respondents

Qualitative 20 or until theoretical data saturation participants will be recruited

Materials crochet hook and yarn.

Recruitment of sample The quantitative and qualitative study will be done using purposive sampling sample survey

The geographic selection of this study is based on the research question Can amigurumi influence the emotional wellbeing of caregivers of children with cancer

Target Population Childhood cancer caregivers This study focuses on caregivers who are caring for children with cancer These caregivers often face overwhelming emotional and physical challenges in their caregiving roles making them the ideal group to explore whether amigurumi can provide a meaningful support and improve their wellbeing

Amigurumi As an art of toy making could be an expression of the bond with the parent and child It is a portable and affordable art which may render its therapeutic benefits anywhere and anytime Hence an art which can connect and build emotional wellbeing is being explored in this study

 Accessible Population To make the study practical, participants will be recruited through Accesslife, a community organization that supports caregivers of children with cancer As this study will be conducted for a long period of at least one and a half yearsThe proximity of the places allows the researcher to connect directly with a group of caregivers who are readily accessible and willing to participate

Geographic FocusThe community selected for this study has families from various backgrounds and different places hence a diverse group of caregivers will be found Hence the geographic selection of this study is based on the research question, ensuring that the study has an accessible population  representing a broader target population while maintaining practical feasibility

 Assessment plan

Quantitative

Frequency tables and percentages will be used to describe the categorical data The quantitative variables in the study will be described using the mean and standard deviation or median and interquartile range after an assessment of the skewness Parametric tests including two sample independent t test will be used to facilitate comparisons in the outcome variable across the sociodemographic groups Appropriate non parametric tests will be used if the assumptions of normality and homogeneity of variance are violated Furthermore paired t tests or their non parametric variants  subject to violation of assumptions will be used to assess the influence of the intervention. Allstatistical analyses will be carried out using Jamovi The researcher will compile items from tools appropriate to assess respite wellbeing of the caregivers and make changes to suit the needs of Amigurumi The researcher will also develop the template for a log book to obtain data from participants

 Qualitative  Once the transcription and translation of the qualitative study have been completed deductive codes from the objectives questions and literature will be taken Inductive codes emerging will also be listed Codes will be then cleaned or merged by comparing This will be further categorized into a family of codes and networked Depending on the type of data obtained suitable analysis will be done and interpreted

 Feasibility study

Key Idea Amigurumi is not just about creating a toy It is about giving caregivers a moment of peace purpose and healing amidst their caregiving journey Keeping this thought in mind and to avoid selection bias a short finger knitting session was conducted on Sunday the 5 January 2025 at Accesslife 

Method Finger Knitting with its rhythmic nature is known to have therapeutic benefits A hands on training of the same was introduced to a group of 4 participants The mathematical implications and the therapeutic benefits of the same were explained during the session 

 Discussion The management and people associated with the centre have expressed the need for such similar sessions To create moments of self care that could help rejuvenate caregivers  with their ongoing responsibilities

 
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