| CTRI Number |
CTRI/2024/01/061689 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Self-reported experiences of patients who have undergone double J stenting procedure for renal calculi. |
|
Scientific Title of Study
|
A study on self-reported experiences of patients who have undergone double J stenting procedure for renal calculi in selected hospital of Udupi District, Karnataka |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angel Chettri |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing, MAHE Manipal. |
| Address |
Manipal College of Nursing, MAHE Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
080373828405 |
| Fax |
|
| Email |
angel_khampa@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melita Sheilini |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Nursing, MAHE Manipal. |
| Address |
Manipal College of Nursing, MAHE Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8095976561 |
| Fax |
|
| Email |
shyli.mel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrSoumya Christabel |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Nursing, MAHE Manipal. |
| Address |
Manipal College of Nursing, MAHE Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9739319382 |
| Fax |
|
| Email |
soumya.christabel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, MAHE Manipal. |
|
|
Primary Sponsor
|
| Name |
Miss. Angel Chettri |
| Address |
Manipal College of Nursing, MAHE, Manipal. |
| Type of Sponsor |
Other [Self ] |
|
|
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 Melita Sheilini |
Manipal College of Nursing,MAHE, Manipal |
Room no.104C.Assistant Professor-Selection Grade, Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal.
Udupi
KARNATAKA |
08095976561
shyli.mel@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants who have undergone Double J stent procedure for renal calculi |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who:
1) underwent double J stenting for renal calculi in KH, Manipal.
2) are willing to participate in the study.
3) are able to read and write Kannada and English.
|
|
| ExclusionCriteria |
| Details |
Patients with chronic renal failure. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The self reported experience of the patient is collected using USSQ scale,
categorized under 6 sections and 38 items:
1.Urinary symptoms
Body pain
2.General health
3.Work performance
4.Sexual matters
5. Additional problems
Interpretation will be done by calculating the score for each section. The findings of the study would help in planning future intervention which will help them in understanding and managing symptomatic patients. |
12 months |
|
|
Secondary Outcome
|
|
|
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)
|
05/02/2024 |
| 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)
|
Not Applicable |
| 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
|
Study will be conducted after obtaining appropriate permission in the urology unit of Kasturba Hospital Manipal. The participants will be explained about the study and their participation in the research. Samples are selected using a convenient sampling technique. To assess the self-reported experiences of the patients who underwent double J stenting for renal calculi, quantitative survey approach will be used. The researcher has adopted descriptive survey. After obtaining the necessary administrative permission and CTRI registration, the data will be collected by administering the tools to the participants. Informed consent will be taken from the participants prior to the data collection and confidentiality of the data will be maintained. The data collection for background information will be collected by using Demographic Proforma and Clinical Proforma. The background information will be collected when the patients come to the urology OPD for double J stenting procedure for renal calculi. The self-reported experience of the patient who underwent double J stent procedure will be assessed by using Ureteral stent symptom questionnaire (USSQ) which is a standardized tool developed to analyse the symptoms of ureteral stents and their effect on quality of life. Questionnaire on symptoms related to double J stent insitu, which is to be filled within seven days. The filled questionnaire should be bought on the day of the stent removal by the participants. The poststent questionnaire will be sent along with the participant on the day of the stent removal which is to be filled within seven days and post it back to the investigator. |