| CTRI Number |
CTRI/2024/10/075365 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sleep quality assessment of cancer patients during peri-operative period |
|
Scientific Title of Study
|
Sleep quality trajectories assessment of cancer patients during perioperative period: an 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 |
Archana Gautam |
| Designation |
Assistant Professor |
| Affiliation |
Kalyan Singh Super Speciality Cancer Institute Lucknow |
| Address |
Kalyan Singh Super Speciality Cancer Institute Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9936343627 |
| Fax |
|
| Email |
archana.dolly76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Gautam |
| Designation |
Assistant Professor |
| Affiliation |
Kalyan Singh Super Speciality Cancer Institute Lucknow |
| Address |
Kalyan Singh Super Speciality Cancer Institute Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9936343627 |
| Fax |
|
| Email |
archana.dolly76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Gautam |
| Designation |
Assistant Professor |
| Affiliation |
Kalyan Singh Super Speciality Cancer Institute Lucknow |
| Address |
Kalyan Singh Super Speciality Cancer Institute Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9936343627 |
| Fax |
|
| Email |
archana.dolly76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalyan Singh Super Speciality Cancer Institute, Lucknow, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Kalyan Singh Super Speciality Cancer Institute Lucknow India |
| Address |
Kalyan Singh Super Speciality Cancer Institute, Lucknow, 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 |
| Dr Archana |
Kalyan Singh Super Speciality Cancer institute |
Room No 205 OPD Block Department of anaesthesia
Lucknow
UTTAR PRADESH |
9936343627
archana.dolly76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kalyan Singh Super Speciality Cancer Institute Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (2) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
It is an observational study so no intervention is given to the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
consenting patients who will be posted for elective cancer surgeries and extubated in operation theatre and then shifted to post-anaesthesia care unit. patients who are conscious and oriented and able to read and write. |
|
| ExclusionCriteria |
| Details |
All Non-consenting onco-surgical patient, age less than 18years and more than 70years, who are on mechanical ventilation in postoperative period or require emergency surgery or develop post-operative complications like who require re-exploration, or mechanical ventilation, dyselectrolemia, and or unable to communicate verbally or through writing, Patients with intracranial lesion), Patients who will be previously diagnosed with any psychiatric disorder and Patients who will be previously diagnosed with sleep disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the sleep quality trajectories of onco-surgical patients during peri-operative period |
at the time of PAC, in the morning of surgery, at post operative day 1, 2, 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify and quantify the main conditioning factors of poor sleep.
i.Individual characteristics (age, gender, education, employment status, marital status, BMI, tobacco and alcohol intake history)
ii.Environmental factors ( fear of new place, pain, noise, monitors alarms, device attached to patient causing discomfort, light, medications received after onset of sleep etc)
iii.Medications used like opioids, benzodiazepine, propofol, haloperidol, phenargen etc.
|
at the time of PAC, in the morning of surgery, at post operative day 1, 2, 3 |
|
|
Target Sample Size
|
Total Sample Size="316"
Sample Size from India="316"
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)
|
21/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [archana.dolly76@gmail.com].
- For how long will this data be available start date provided 03-09-2024 and end date provided 03-09-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim of the study is to assess sleep quality trajectories of cancer patients during peri-operative period and to track down risk factors which causes sleep disturbance. objectives are to study quality trajectories and identify and quantify the main conditioning factors of poor sleep. Study will start after getting ethical clearance, study duration will be 12 months. Sample size is 316. patients who come to PAC clinic will be screen for study. only those patients will be enrolled who will give consent and fullfill inclusion and exclusion criteria. Socio-demographic will be recorded. history of chemotherapy and radiotherapy and current medications will be noted. ASA physical status and ECOG score will be roecorded. then every enrolled patient, their sleep quality will be asked Richard Campbell Sleep Questionnare (RCSQ) as a baseline score during their PAC visit and in the morning of surgery and in postoperative period till day 3. there is minimal risl to patients. the potential outcomes will be that cancer patients during peri-operative period will be having distuebed sleep and their gravity and factors causing disturbed sleep. |