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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Improvement in quality of sleep and well being in hemodialysis patient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Improvement in quality of sleep and well being in hemodialysis patient
Time Frame: At 4 weeks and 12 weeks
Secondary Outcomes
- improvement in functional well being in hemodialysis patient(after 4- 8 weeks)
Investigators
Richa Jha
AIIMS NEW DELHI