| CTRI Number |
CTRI/2026/03/106175 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pain in Children with Cerebral Palsy and Its Effect on Their Quality of Life and Sleep |
|
Scientific Title of Study
|
A Study On Pain In Children With Cerebral Palsy And Its Impact On Their Health Related Quality Of Life And Sleep |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tamanna |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of pediatrics
child development center room no. 310 Maulana Azad Medical College
110002-Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9306477313 |
| Fax |
|
| Email |
tamannayadav127@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monica Juneja |
| Designation |
Head of the department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of pediatrics
child development center room no. 310 Maulana Azad Medical College
110002-Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tamanna |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of pediatrics
child development center room no. 310 Maulana Azad Medical College
110002-Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9306477313 |
| Fax |
|
| Email |
tamannayadav127@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Paediatrics, Maulana Azad Medical College
110002-Bahadur Shah Zafar Marg, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department Of Paediatrics, Maulana Azad Medical College
110002-Bahadur Shah Zafar Marg, New Delhi |
| Type of Sponsor |
Government 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 Tamanna |
Maulana Azad medical College |
Department of pediatrics
Maulana Azad medical College
110002-Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
9306477313
tamannayadav127@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children Of Either Sex Diagnosed As Cerebral Palsy Using The American Academy Of Neurology Criteria.
Aged 2-12 years.
Accompanied By The Primary Caregiver. |
|
| ExclusionCriteria |
| Details |
We can enroll any child with cerebral there is no exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion Of Children With Cerebral Palsy Experiencing Pain In Last Four Weeks Using
Parental Report Of “Bodily pain” Concept of the Child Health Questionnaire. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentages Of Children Having Different Severity Levels And Different Frequency
Of Pain Over 4 Weeks Measured Using Parental Report Of “Bodily pain” Concept
Of Child Health Questionnaire |
Baseline |
Association Of Severity And Frequency Of Pain Over The Last 4 Weeks With:
Health Related Quality Of Life Measured By PedsQL 4.0 Generic Core
Scales And PedsQL 3.0 Cerebral Palsy
Sleep Problems Of Children Measured By BEARS Sleep Screening Tool. |
Baseline |
Proportion Of Children Having Pain And The Percentages Of Children Having
Different Severity And Different Frequency Of Pain Over Last 1 Week Using Child’s
Self-Report Of “Bodily Pain” Concept Of The Child Health Questionnaire In
Children With Cerebral Palsy Having Physical, Cognitive Capacity To Self-Report. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A cross sectional observational study conducted in department of pediatrics, Maulana Azad Medical College, New Delhi-110002 to study pain in children with cerebral palsy aged 2 to 12 years and its impact on their health related quality of life and sleep. A predesigned structured proforma will be filled that would include their sociodemographic details, clinical history including pain related history an presence of various comorbidities. Requirement of analgesics over 4 weeks and frequency of requirement of analgesics to be documented. gmfcs level and Dq to be documented as well. Assessment of pain via "bodily pain" concept of Child Health Questionnaire to be reported by primary caregiver. Quality of life assessment by Pedsql 3.0 cerebral palsy module and Pedsql 4.0 generic core scales and sleep assessment by BEARS sleep screening tool. Reporting of pain can be done in last 1 week by children who have capacity of self report using "bodily pain" concept of Child Health Questionnaire. |