| CTRI Number |
CTRI/2019/02/017378 [Registered on: 01/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to check the Quality of Sleep, Intensity of Pain and Mental Stress in Patients undergoing Hemodialysis. |
|
Scientific Title of Study
|
A STUDY ON SLEEP QUALITY , PAIN SEVERITY AND DEPRESSION IN PATIENTS UNDERGOING MAINTENANCE HEMODIALYSIS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DANIEL ANILA ROY |
| Designation |
STUDENT |
| Affiliation |
|
| Address |
FIFTH YEAR PHARM.D ,
DEPARTMENT OF PHARMACY PRACTICE, NGSMIPS,
AFFILIATED TO NITTE(DEEMED TO BE UNIVERSITY), DERALAKATTE,MANGALURU.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9409577334 |
| Fax |
|
| Email |
aniladanielroy07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JUNO J JOEL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
DEPARTMENT OF PHARMACY PRACTICE,NGSMIPS,
AFFILIATED TO NITTE(DEEMED TO BE UNIVERSITY),DERALAKATTE, MANGALURU.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DANIEL ANILA ROY |
| Designation |
STUDENT |
| Affiliation |
|
| Address |
FIFTH YEAR PHARM.D ,
DEPARTMENT OF PHARMACY PRACTICE,NGSMIPS,
AFFILIATED TO NITTE(DEEMED TO BE UNIVERSITY), DERALAKATTE, MANGALURU.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9409577334 |
| Fax |
|
| Email |
aniladanielroy07@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
NITTE Deemed to be University |
| Address |
6TH FLOOR, UNIVERSITY ENCLAVE, MEDICAL SCIENCES COMPLEX, DERALAKATTE, MANGALURU ,KARNATAKA - 575018. |
| Type of Sponsor |
Other [PRIVATE UNIVERSITY] |
|
|
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 |
| DANIEL ANILA ROY |
Justice K.S Hegde Charitable Hospital |
3RD FLOOR, DIALYSIS UNIT , DEPARTMENT OF NEPHROLOGY, JUSTICE K S HEGDE HOSPITAL Deralakatte , Mangaluru - 575018
Dakshina Kannada
KARNATAKA |
9409577334
aniladanielroy07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , NGSM INSTITUTE OF PHARMACEUTICAL SCIENCES. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N18||Chronic kidney disease (CKD), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
OUTPATIENTS OF EITHER SEX UNDERGOING MAINTENANCE HEMODIALYSIS. |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO ARE NOT WILLING TO GIVE CONSENT. HEARING, SPEECH OR COGNITIVE DEFECTS THAT WOULD INTERFERE WITH THEIR ABILITY TO UNDERSTAND AND ANSWER QUESTIONS FROM THE SCREENING TOOLS USED IN THE STUDY.
PATIENTS UNDERGOING HEMODIALYSIS FOR CONDITIONS OTHER THAN END STAGE RENAL DISEASE. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study expects to examine the occurrence of sleep quality, pain and depression in Indian patients undergoing maintenance hemodialysis |
SINGLE POINT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study expects to find the associaton between sleep quality, pain and depression in patients undergoing maintenance hemodialysis |
SINGLE POINT
|
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/02/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TITLE: A STUDY ON SLEEP QUALITY, PAIN SEVERITY AND DEPRESSION IN PATIENTS UNDERGOING MAINTENANCE HEMODIALYSIS. INTRODUCTION: Hemodialysis patients are very much vulnerable to emotional problems because of the chronic stress related to disease burden, dietary limitations, functional limitations, concomitant diseases, adverse drug reactions etc. Even though certain studies on depression, pain severity and sleep quality were conducted ,majority of the studies were conducted in western countries. research findings on this mental health related issue in Indian hemodialysis patients is scarce. OBJECTIVES : - To assess the occurrence of sleep problems, pain and depression in patients undergoing maintenance hemodialysis.
- To study the association between sleep quality , pain severity and depression in hemodialysis patients.
METHODOLOGY: A six months cross sectional study will be conducted in the outpatients hemodialysis centre of Justice K S Hegde Charitable Hospital , Mangaluru , Karnataka . Patients of either sex undergoing maintenance hemodialysis will be included in the study. Ethical committee approval is obtained prior to the study .The aim of the study will be explained to all the participants and all of them will be made to sign the informed consent before participation and will be assured about the confidentiality and freedom to withdraw from the study. The patients will be assessed for sleep quality , pain and depression using standard self report questionnaires [ Pittsburgh Sleep Quality Index(PSQI) , Visual Analog Scale (VAS) , Beck Depression Inventory (BDI)]. Prior to the use of questionnaires permission will be obtained from the concerned authorities . The validated versions of kannada and malayalam will be used for the assessment. A minimum sample size of 60 is considered, subjected to the availability of the patients during the period of study. ANTICIPATED OUTCOME: This study expects to assess the occurrence of sleep quality , pain and depression in patients undergoing maintenance hemodialysis and their association with a hope that findings may suggest appropriate intervention strategies for hemodialysis patients.
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