| CTRI Number |
CTRI/2017/03/008248 [Registered on: 29/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy of pain and comfort scores for pain assessment
|
|
Scientific Title of Study
|
A randomized comparative study assessing efficacy of pain vs comfort scores
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Jain |
| Designation |
Assistant Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital
Tagore Nagar
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815068242 |
| Fax |
|
| Email |
richajain2105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Jain |
| Designation |
Assistant Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital
Tagore Nagar
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815068242 |
| Fax |
|
| Email |
richajain2105@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Jain |
| Designation |
Senior Resident |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital
Tagore Nagar
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815068242 |
| Fax |
|
| Email |
richajain2105@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar
Ludhiana-141001 (Punjab) |
| Type of Sponsor |
Private 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 |
| Richa Jain |
Dayanand Medical College and Hospital |
Department of Anaesthesia
First floor
Ludhiana
PUNJAB |
9815068242
richajain2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayanand Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
post caesarean section women, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All women who underwent caesarean section. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Deaf and dumb patients
3. Patients with intellectual disability
4. History of chronic pain or opiate abuse
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our primary outcome is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort. |
between 10 to 30 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Our secondary outcomes include:
1. pain severity as measured by a VAS for pain compared with VAS for comfort;
2. whether the surgical wound is worrysome,
3. the level of worry as measured by a 0–10-point scale,
4. whether the patient required additional analgesia;
5. whether the patient preferred to be asked about their comfort level or pain level;
6. whether the patient considered the postoperative wound to be injury and disability or healing and recovery.
|
between 10 to 30 hours |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2016 |
| Date of Study Completion (India) |
30/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2. Original article - A randomized comparative study assessing efficacy of pain versus comfort scores: Jain R, Grewal A; Saudi J Anaesth 2017;11:396-401. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a single blinded randomized study to compare standard pain scores with comfort scores after caesarean section and to determine whether the technique of pain assessment affects patient’s perceptions and experience after caesarean section. One hundred eighty eligible women will be randomly allocated into 2 groups (i.e. group P and group C) of 90 women each, and will be interviewed 6- 24 hours after caesarean section. Group P women will be asked to rate their pain and group C women will be asked to rate their comfort level according to previously validated structured questionnaire. The outcomes of our study is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort and also by a VAS for pain compared with VAS for comfort. Additional outcomes include assessment of level of worry caused by surgical trauma, the requirement of additional analgesia and patient’s perception of postoperative wound as injury or healing |