| CTRI Number |
CTRI/2025/05/087191 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of a sleep wellness program on sleep quality and functional well-being among hemodialysis patients.
|
|
Scientific Title of Study
|
A study to evaluate the effectiveness of a sleep wellness program on sleep quality and functional well-being among hemodialysis patients at a tertiary care hospital.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Jha |
| Designation |
Msc nursing student |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Porta cabin 2
College of Nursing
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8447817937 |
| Fax |
|
| Email |
RICHAJHA1888@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajesh Kumar T K |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 1Porta cabin Second Floor
COLLEGE OF NURSING
AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajesh Kumar T K |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 1 Second floor Porta Cabin
College of Nursing
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Ansari Nagar New Delhi 110068 |
|
|
Primary Sponsor
|
| Name |
Richa Jha |
| Address |
College of nursing
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Arun |
AIIMS Ansari Nagar 110029 New Delhi |
New RAK OPD C wing Nephrology
South
DELHI |
9968969076
RICHAJHA1888@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine OPD information |
In control group routine OPD information will be provided to patients.
Time duration 12 weeks |
| Intervention |
sleep wellness program |
• In experimental group one to one teaching will be given to the participants for 30 mins with the help of information booklet and video of muscle relaxation technique. Time duration 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above.
Patients undergoing regular maintenance hemodialysis for at least 3 months.
Participants must have full consciousness and adequate auditory and verbal ability to respond to questions.
Patients willing to participate and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients undergoing peritoneal dialysis or any modality other than hemodialysis.
2.Presence of advanced cardiovascular or pulmonary disease interfering with sleep
3.A history of confirmed psychiatric disorders
4.A history of drug addiction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of sleep and well being in hemodialysis patient |
At 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| improvement in functional well being in hemodialysis patient |
after 4- 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
01/08/2025 |
| 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="0"
Months="5"
Days="0" |
|
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
|
This study evaluates the effectiveness of a structured sleep wellness program in improving sleep quality and functional well-being among hemodialysis patients at AIIMS, New Delhi. A randomized controlled trial will compare an experimental group receiving the program (education on sleep hygiene, relaxation techniques, and sleep diaries) with a control group receiving routine care. Sleep quality and functional well-being will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The study aims to address the high prevalence of sleep disturbances in hemodialysis patients and their impact on quality of life, providing evidence for integrating sleep interventions into routine clinical care. |