| CTRI Number |
CTRI/2026/02/103178 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The Long-Term Effects of Pain Memories on Children’s Well-Being After Major Surgery |
|
Scientific Title of Study
|
The long-term Impact of Pain Recall on Quality of Life in Pediatrics Patients Following Major Surgery- A PROPECTIVE OBSERVATIONAL STUDY |
| 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 Sumitra Bakshi |
| Designation |
Consultant Anasthesia, critical care and Pain management |
| Affiliation |
TATA MEMORIAL HOSPITAL MUMBAI |
| Address |
Department of Anesthesia, Critical Care and Pain.
2 nd Floor,
Main building Dr. E Borges Road, Parel, Mumbai -
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Consultant Anasthesia, critical care and Pain management |
| Affiliation |
TATA MEMORIAL HOSPITAL MUMBAI |
| Address |
Department of Anesthesia, Critical Care and Pain, @nd Floor Main Building,
Dr. E Borges Road, Parel, Mumbai -
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
krishnapriya Watharkar |
| Designation |
Junior Resident |
| Affiliation |
TATA MEMORIAL HOSPITAL MUMBAI |
| Address |
Department of Anesthesia, Critical Care and Pain,
2nd floor Main Building,
Parel, Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
8055262899 |
| Fax |
|
| Email |
krishnapw.97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Critical Care and Pain.
Tata Memorial Hospital. |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital, Mumbai |
| Address |
Dr Ernest Borges Road, Parel East, Parel,
Mumbai, Maharashtra – 400012, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| krishnapriya Watharkar |
Paediatric OPD, Main building, Tata Memorial Hospital |
Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai - 400 012
Mumbai
MAHARASHTRA |
08055262899
krishnapw.97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Is the patient age between 5-18 years
2) Has the patient willingly given written informed consent?
3) Patient planned for major elective surgery
4) Patient clinically stable at the time of enrolment
5) Patient and parents/guardian fluent in any of the commonly used threelanguages accepted in this region (Marathi, Hindi, English).
|
|
| ExclusionCriteria |
| Details |
1) Refusal or withdrawal of consent/assent by parent or child
2) Recent surgery within the last 4 weeks
3) Patient with cognitive or developmental impairments that interfere with comprehension or ability to recall or report pain/quality of life
4) Patient with severe psychiatric conditions (e.g., major depression, psychosis) that could confound pain or QoL assessments
5) Patient undergoing palliative surgery/ with R plus(residual tumor) resection.
6) Patient already with a chronic pain condition that would interfere with post-surgical pain experience
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the incidence of memory of pain in long term and prevalence of its impact in quality of life, if any. |
Pre-operative period
3 months post surgery
6 months post surgery
12 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Severity of pain full memories recalled using Wong Bakers scale.
2) Comparison of severity of pain recalled versus pain perceived in the post operative period (noted using Wong Bakers scale prior to discharge post-surgery- either de-emphasize or catastrophizing).
3) To evaluate the long-term impact of “pain” recall on overall well-being & recovery with respect to return to normal life using The Peds QL. Quality of life will be measured before surgery (baseline) & post-surgery at interval of three month & six months post-surgery.
4) To identify factors that contribute to recall of experience (age, type of surgery, type of pain management, severity of post-operative pain, duration of hospital stays, adjuvant treatment received/ planned). |
Pre operatively
3 months postoperatively
6 months postoperatively
12 months postop |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
17/02/2026 |
| 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="1"
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
|
Children who undergo major cancer-related surgeries often experience pain during their hospital stay. While doctors and nurses try their best to manage this pain, some children may still remember the pain they felt during or after the surgery. These painful memories may affect their emotions, behavior, and overall well-being, even many months after the surgery. This study aims to understand how many children remember their pain after surgery and whether those memories affect their quality of life over time. We will be studying children between the ages of 5 and 18 years who are undergoing major planned (elective) surgeries for cancer. We will ask the children and their parents to fill out simple questionnaires about pain and quality of life at four different times: - Before the surgery (to understand their baseline condition), - 3 months after surgery - 6 months after surgery - 12 months after surgery We will use special tools like the Wong-Baker FACES Pain Scale (which uses pictures of faces to show how much pain the child feels or remembers) and the PedsQL questionnaire (which helps us understand how the child is feeling physically, emotionally, and socially). We will also look at whether certain factors—like the child’s age, type of surgery, pain medicines given, length of hospital stay, or cancer treatment—are linked to stronger or more distressing pain memories. Our goal is to find out how common and how serious these pain memories are and whether they affect the child’s long-term recovery and return to normal life. The results of this study will help doctors and caregivers plan better ways to support children during and after surgery, especially in managing pain and emotional recovery. |