| CTRI Number |
CTRI/2021/11/038203 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video as an intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the Effect of showing Colposcopy findings to the patient, in reducing patient anxiety compared to conventional colposcopy - A Randomized Controlled Trial. |
|
Scientific Title of Study
|
Effect of Video Colposcopy in reducing patient anxiety compared to conventional colposcopy - A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANEESHA P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 303, Old blackwell hostel, Jawaharlal Institute of Postgraduate Medical Education and Research Campus, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8197736291 |
| Fax |
|
| Email |
maneesha.p24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sairem Mangolnganbi Chanu |
| Designation |
Assistant professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8794713545 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sairem Mangolnganbi Chanu |
| Designation |
Assistant professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Mahe
PONDICHERRY
605006
India |
| Phone |
8794713545 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Intramural funding committee, JIPMER, Puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER INTRAMURAL |
| Address |
JIPMER DHANVANTARI NAGAR PUDUCHERRY |
| 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 Maneesha P |
Jawaharlal Institute of Post graduate Education and Research |
Colposcopy clinic,WCH OPD building JIPMER,
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
8197736291
maneesha.p24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional colposcopy |
Patients who will not be viewing the findings of their colposcopy examination |
| Intervention |
Video Colposcopy |
One study group will be shown the findings of their colposcopy examination. Duration: will take same time for both groups. The procedure will take about 10 mins. with the questionnaires, total time: 30 mins |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women attending colposcopy clinic
2. Age 25-65 years
3. First visit to colposcopy clinic.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Diagnosed Anxiety disorder.
3. Other Gynecological malignancy.
4. Women who cannot understand Tamil.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of video colposcopy on anxiety
levels using STAI score in women undergoing
colposcopy compared to those undergoing
colposcopy without Video colposcopy. |
Questionnaire 1:10 minutes Before the colposcopy procedure.
questionnaire 2: Immediately after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of video colposcopy on pain
using VAS in women undergoing colposcopy
guided biopsy compared to those undergoing
colposcopy guided biopsy without Video
colposcopy. |
At the time of visit |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL yet |
|
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maneesha.p24@gmail.com].
- For how long will this data be available start date provided 01-08-2021 and end date provided 01-07-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - none
|
|
Brief Summary
|
Cervical cancer is one of the most common malignancies in developing countries. 1 Women experience high level of anxiety at all stages of evaluation of cervical cancer from pap smear, colposcopy to treatment. Colposcopy is a standard procedure in evaluation of cervical dysplasia. Most women are not aware of the anatomy and the procedure is associated with additional anxiety as it is for the diagnosis of a possible cancerous lesion. 2–4 This leads to higher discomfort, disappointment in own body, anxiety, doubts regarding reproduction and loss to follow up. The level of anxiety can be greater than those measured in women awaiting major surgery. 5 As it is important to reduce the anxiety level in patients referred for colposcopy, interventions which can reduce this anxiety are useful. There are studies which have tried interventions such as pre-procedure counselling, music, individual information regarding the procedure, information brochures. Another intervention that is being tried is video colposcopy. Video colposcopy involves live video demonstration of the colposcopy procedure to the patient. The patient gets to view in real time and understand the procedure when it is performed.Video colposcopy enables patients to understand the anatomy and disease condition better, hence may reduce patient anxiety |