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CTRI Number  CTRI/2025/01/079403 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To understand how treatment in hemodialysis patients is effected by depression , anxiety stress and self-esteem  
Scientific Title of Study   Relationship of depression , anxiety , stress and self esteem on medical adherence in dialysis patient 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirmith kakade 
Designation  Master student  
Affiliation  Manipal college of health professions  
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka

Bangalore
KARNATAKA
560017
India 
Phone  8155053377  
Fax    
Email  nirmith.mhsblr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  jeeshma.vijin@manipal.edu 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka

Bangalore
KARNATAKA
560017
India 
Phone  08217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  jeeshma.vijin@manipal.edu 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka

Bangalore
KARNATAKA
560017
India 
Phone  08217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore,India 560017,  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal,576104 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nirmith kakade  Manipal Hospitals, Bangalore  Department of dialysis, Ground floor, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA 
8155053377

nirmith.mhsblr2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patient who have been undergoing haemodialysis for at least 6 months 
 
ExclusionCriteria 
Details  Patient who are undergoing peritoneal dialysis 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)  at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
DEPRESSION ANXIETY STRESS SCALE 21
Rosenberg self esteem scale  
At baseline 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/02/2025 
Date of Study Completion (India) 30/05/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

In 2018 , the prevalence of chronic dialysis patients was 127 per million people. India has an

increasing number of patient who require dialysis due to kidney failure , hence there is a

requirement in to understand the what factors effect the treatment adherence for dialysis patient

so we can improve treatment efficiency. Adherence is defined by the WHO ,as the degree to

which the person behaviour corresponds with the agreed recommendation from a health care

provider.

Most patient only show a moderate level of adherence to treatment , despite the consequences

and health complication . Factors such as low socioeconomic status , lack of education about

the illness and importance of adherence , low support from family are prominent in literature .

Depression is marked by low mood, lack of pleasure in previously enjoyable activites and

fatiguability. Depression is prevalent in dialysis patient , and showed a reduce dietary and

medical adherence . 

Anxiety is the Vague and unpleasant emotion , based on anticipation of some real or imagine

situation . Anxiety at lower level , can be beneficially , but chronic anxiety and high level of

anxiety can impair functioning. Anxiety can cause many of physical and psychological

symptoms ,such as increased heartrate ,sweating , palpitation , restlessness, sleeping

difficulties, poor concentration.

Stress is a physiological reaction that use mobilizes body to burn resources to meet the

requirement of a situation. Stress shows similar symptoms to anxiety , though a key difference

is that for stress there needs to a stressor , a situation that leads to stress .

Self esteem is the evaluation of the self. High self esteem leads to belief that one is a good

person ,vice versa.

 
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