End Stage Chronic Renal Failure, Hemodialysis
Conditions
Brief summary
This study aims to evaluate whether an MBI improves sleep quality, emotional symptoms (depression, anxiety, stress), emotion regulation, and trait mindfulness among adults with ESRD on HD. A randomized two-arm pre-post design was conducted with N = 38 patients at Dr. Soliman Fakeeh Hospital (DSFH), Saudi Arabia (n = 19 intervention; n = 19 control). The intervention comprised 30-minute guided sessions, 3 times a week for 5 weeks during HD sessions. The control group received the study intervention after the study. Outcomes were assessed at baseline and post-intervention using the Pittsburgh Sleep Quality Index (PSQI), Depression Anxiety Stress Scale-21 (DASS-21), Emotion Regulation Questionnaire (ERQ), and Mindful Attention Awareness Scale (MAAS).
Interventions
BEHAVIORALMindfulness-Based Intervention
The intervention was a structured audio-based MBI program over a five-week period during regular hemodialysis procedure. The program, delivered using validated audio recordings, drew on the principles of mindfulness-based stress reduction (MBSR) and was tailored to the needs of hemodialysis patients . The intervention group participated in daily 30-minute sessions of guided MBI three times a week for five weeks. These sessions took place during the dialysis sessions to improve the feasibility and avoid placing further burdens on participants. The mindfulness intervention involved a number of key elements, such as focusing on the breathing, body scanning, awareness of the present moment and nonreactive monitoring of thoughts and feelings. Participants were advised to become mindful of their thoughts, feelings, and sensations, without trying to change them. The program also taught acceptance-based approaches and cognitive diffusion from negative thought
Sponsors
Jordan University of Science and Technology
Fakeeh College for Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being aged 18 or above * having a history of maintenance dialysis for three months * having the capacity to self-report
Exclusion criteria
* Having acute psychiatric illness or substantial cognitive dysfunction * Involving in frequent meditation or yoga practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | From enrollment to the end of intervention at 5 weeks | It is used to gain a broad understanding of sleep architecture over the previous 30 days. This 19-item self-report questionnaire assesses seven components of sleep: sleep quality; sleep latency (time to fall asleep); sleep duration; sleep efficiency (time asleep, relative to total time in bed); sleep disturbances; use of sleeping medication; and daytime dysfunction (Buysse et al., 1989). The score for each component ranges from 0 to 3. Added together, the scores of the seven components produce a Global Sleep Quality Score, ranging from 0 to 21. |
| Depression, Anxiety, and Stress Scale (DASS-21) | From enrollment to the end of intervention at 5 weeks | The DASS-21 was used to assess the psychological distress of having end-stage renal disease. This scale includes three 7-item subscales that distinguish between the key elements of depression (e.g., dysphoria, hopelessness), anxiety (e.g., autonomic arousal, skeletal muscle effects) and stress (e.g., irritability, impatience). Respondents are asked to respond on a 4-point Likert scale according to how they have felt in the last week. As a shortened form of the original 42-item DASS, the scores of each of the three DASS-21 subscales are doubled to reflect ratings for the standard severity levels (from "Normal" to "Extremely Severe") |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Emotion Regulation Questionnaire (ERQ) | From enrollment to the end of intervention at 5 weeks | The ERQ assesses how participants regulate their emotions in response to the stressful situation of living with chronic illness. This 10-item questionnaire assesses two distinct strategies of emotion regulation, including cognitive reappraisal (6 items) and expressive suppression ( 4 items). Cognitive Reappraisal is an antecedent-focused strategy that involves changing the way one thinks about a stressful situation in order to modify its emotional effect (e.g., "When I am feeling down, I change the way I think about the situation to improve the way I feel"). Expressive Suppression is a response-focused strategy by which individuals control their emotions by suppressing their expression (e.g., "I keep my emotions to myself"). Responses are scored from 1 to 7 (1 = I strongly disagree, 7 = I strongly agree). Generally, higher reappraisal scores are associated with better mental health, and higher suppression scores with greater mental distress. |
| Mindful Attention Awareness Scale (MAAS) | From enrollment to the end of intervention at 5 weeks | The MAAS is used to measure "trait mindfulness" - the tendency to be aware of present-moment experiences in a nonjudgmental, nonreactive way. It This 15-item questionnaire measures the trait-like presence or absence of attention to current moment experiences rather than religious or meditative practices. Respondents rate items (e.g., "I find myself doing things without paying attention") on a 6-point scale (1 = almost always to 6 = almost never). A higher mean score indicates higher trait mindfulness. |
Countries
Saudi Arabia
Outcome results
None listed