A study to understand the experience of sleep disturbances, fatigue and quality of life among patients undergoing Hemodialysis and to assess the effect of a counselling technique on their sleep, Fatigue and Quality of life.

A study to explore the lived experience of sleep disturbances, fatigue and quality of life among patients undergoing Hemodialysis and to evaluate the effect of Cognitive Behavioural Therapy on their sleep, Fatigue and Quality of life in selected hospitals, Kerala.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/02/005503

Enrollment

138

Registered

2015-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease Health Condition 2: null- Sleep, Fatigue and Quality of life among patients undergoing Hemodialysis

Interventions

Intervention1: COGNITIVE BEHAVIOURAL THERAPY (CBT): 6 sessions of individual CBT (2 sessions per week) for 3 weeks Each session will last for approximately 20 to 25 minutes. CBT will be given during d

Eligibility

Inclusion criteria

Inclusion criteria: -Patients who are undergoing maintenance hemodialysis for more than 3 months. -Patients who are above the age of 18 years- -Subjects without active medical and psychiatric conditions.

Exclusion criteria

Exclusion criteria: - Patients who are admitted in the ward and undergoing hemodialysis - Patients who are critically ill when undergoing hemodialysis

Design outcomes

Primary

Measure	Time frame
Quality of sleep, among Hemodialysis patientsTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention	—

Secondary

Measure	Time frame
Level of fatigue among Hemodialysis patientsTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention;Quality of life among Hemodialysis patientsTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention;Relationship between sleep, fatigue and quality of lifeTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention	—

Measure

Time frame

Level of fatigue among Hemodialysis patientsTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention;Quality of life among Hemodialysis patientsTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention;Relationship between sleep, fatigue and quality of lifeTimepoint: Assessed at Baseline (Day 0), Post intervention 2 weeks( Day 15), and 6 weeks (Day 43) and 10 weeks (Day 71) after the intervention

—

Countries

India

Contacts

Public ContactROHINI T

National Consortium for Ph.D in Nursing affiliated to RGUHS, Bangalore

punitha.ezhilarasu@gmail.com09486415511

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026