| CTRI Number |
CTRI/2025/08/093473 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of SCOPE program among CKD patients |
|
Scientific Title of Study
|
Impact of SCOPE Program on selected parameters among the Patients with Chronic Kidney Disease undergoing Haemodialysis in Puducherry. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bathula Laxmi Chaitanya |
| Designation |
PhD Scholar cum Asst. Lecturer in Nursing |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
No. 5
II cross
Vallalar Nagar
lawspet
Puducherry
College of Nursing
Indira Nagar
Gorimedu
Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
9500067370 |
| Fax |
|
| Email |
laxmichaitanya@mtpgrihs.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V POONGODI |
| Designation |
PROFESSOR IN NURSING |
| Affiliation |
Sri Balaji Vidyapeeth University |
| Address |
No. 115, 11th cross, Kanagasabai Nagar, Chidambaram, Cuddalore District, Tamil Nadu
Dept of OBG,
Kasturba Gandhi Nursing College,
Puducherry
Cuddalore
TAMIL NADU
608001
India |
| Phone |
09585340354 |
| Fax |
|
| Email |
poongodiv@kgnc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bathula Laxmi Chaitanya |
| Designation |
PhD Scholar cum Asst. Lecturer |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
No. 5
II cross
Vallalar Nagar
lawspet
Puducherry
college of Nursing
Indira Nagar
Gorimedu
Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
9500067370 |
| Fax |
|
| Email |
laxmichaitanya@mtpgrihs.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
B Laxmi Chaitanya |
| Address |
PhD Scholar cum Asst. Lecturer in Nursing
college of Nursing
Mother Theresa Post Graduate and Research Institute of Health Sciences
Indira Nagar, Gorimedu, Puducherry |
| 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 S SEVVEL |
Indira Gandhi Government General Hospital and Post Graduate Institute |
victor Simonel Street
White Town
PUDUCHERRY
605001
Pondicherry
PONDICHERRY |
09443439875
msgh.pon@nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOTHER THERESA POST GRADUATE AND RESEARCH INSTITUTE OF HEALTH SCIENCES INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SCOPE |
consists of 5 sessions, with weekly one session. Each session will lasts for 20-30 minutes. The subjects selected for the study group are being sorted into 6 subgroups by lottery method after filling the tools of the study; each subgroup contains 8-9 participants.
The sessions included the SCOPE program are
Session 1: Deep breathing exercise
Session 2: Muscle relaxation technique and Intradialytic stretching exercises
Session 3: Treatment adherence
Session 4: Sleep hygiene
Session 5: Coping skills with CKD |
| Comparator Agent |
STANDARD CARE |
STANDARD CARE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing Hemodialysis regularly for more than six weeks
Aged 18 to 60 years old
Able to understand either English or Tamil
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Undergoing Hemodialysis for a condition other than CKD
Having CKD with other complications.
Planned for renal transplant.
Planned for transfer to another dialysis setting and undergone any other interventional protocol.
Having debilitating other illnesses
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
RLS
FATIGUE
SLEEP QUALITY
QUALITY OF LIFE |
RLS
FATIGUE
SLEEP QUALITY
QUALITY OF LIFE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THE STUDY WILL BE CONDUCTED AFTER GETTING PRIOR PERMIISION AND CONSENT FROM THE SUBJECTS. AFTER COMPLETION OF THE STUDY, THE RESULTS WILL BE PUBLISHED IN THE JOURNALS ACCORDINGLY WITH MENTIONING CTRI NUMBER AFTER APPROVAL. |