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Clinical Trials/NCT06064708
NCT06064708CompletedNot Applicable

The Impact of Mindfulness-Based Intervention on Psychophysical Health in Patients Undergoing Hemodialysis: An Experimental Study

Jordan University of Science and Technology2 sites in 1 country64 target enrollmentStarted: April 10, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Tumor necrosis factor-alpha

Study Overview

Brief Summary

Background: Hemodialysis is considered as an effective therapy to remove harmful wastes from the body and to improve the quality of life in patients suffering from end-stage renal disease (ESRD). However, patients who receive hemodialysis perceive various stressors that are harmful to their physical and psychological well-being, particularly the immune system. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention is an effective mind-body connection program that is inadequately used in patients undergoing hemodialysis.

Objective: The current study aimed to investigate the effect of mindfulness-based intervention on physical and psychological symptoms (e.g., stress, anxiety, and depression) and pro-inflammatory biomarker levels (e.g., TNF, interleukin-6, and C-reactive protein) in patients with ESRD undergoing hemodialysis.

Method: Repeated measures, randomized, control experimental design was used. A convenience non-probability sampling technique to select the sample from the hemodialysis unit in the Princess Haya Bint AL_Hussine Hospital. The participants who were eligible and agreed to participate were randomly distributed into experimental (n = 31) and control (n = 30) groups. During their hemodialysis sessions, the experimental group' participants practiced 30-minute mindfulness-based intervention; three times a week for eight weeks). The Mindful Attention Awareness Scale (MAAS), Depression, Anxiety, and Stress Scale - 21 (DASS-21), Patient Health Questionnaire (PHQ-15), and serum blood levels (for tumor necrosis factor, interleukin-6, and C-reactive protein) were used to measure the dependent variables for both groups at baseline, after five weeks of the intervention, and at its end (eight weeks).

Detailed Description

Hemodialysis is considered as an effective and essential therapy to remove harmful wastes from the body and to improve the quality of life (QoL) of end-stage renal disease (ESRD) patients. However, patients undergoing hemodialysis experience multiple stressors (Finnegan-John & Thomas, 2013), negatively affecting their psychological and physical health, especially in relation to the immune system (Black & Slavich, 2016). Previous studies have indicated that patients undergoing maintenance hemodialysis experience a variety of physical and psychological symptoms (i.e., anxiety, fatigue, muscular spasms, and joint and bone pain), caused by a combination of stress, the disease itself, and intensive treatment (Hackett & Jardine, 2017; Hintistan, & Deniz, 2018), which has diverse effects including increased suicidal ideation (Yavuz, et al., 2022), impaired physical activity (Mallamaci et al., 2020), reduced QoL (Vasilopoulou et al., 2016), increased susceptibility to infectious disease (Maydych, 2019), and increased mortality and morbidity (Lv & Zhang, 2019).

High levels of blood proinflammatory markers, including C-reactive protein (CRP), tumor necrosis factor alpha (TNF-α), and interleukine-6 (IL-6), have been found in the majority of patients with ESRD (Abdel-Messeih et al., 2020; Park et al., 2022). The aetiology of inflammation in patients with ESRD is multidimensional, including patient-related causes, such as ESRD-related symptoms, comorbidity, and hemodialysis-related issues, especially those relating to the biocompatibility and quality of the dialysate and the dialysis membrane. These high levels of proinflammatory biomarkers in ESRDPs have been found to cause injury to other bodily organs in addition to the kidney, increasing morbidity and mortality (Abdel-Messeih et al., 2020).

Mind-body connection strategies such as mindfulness-based interventions (MBIs) are purposefully adopted in a wide range of structured interventions and have been proven to be highly effective in treating many physical and psychological symptoms of a wide range of psychiatric conditions associated with diverse chronic illnesses (Chu et al., 2021). MBIs reinforce adaptive coping processes and enhance positive reappraisal (Aliche & Onyishi, 2020). They enhance coping, reduce stress, improve mood and enhance the quality of spirituality and personal development in the adaptation of ESRD diagnosis and treatment (Sohn et al., 2018). They can also aid patients to be less reactive and to deal with fluctuating feelings through learning to accept the current experience more effectively, which ultimately reduces physical and emotional stress reactions (Chin-Lun Hung, 2019). Stress and emotional reactions are associated with increased levels of proinflammatory markers, whereby MBI could be effective in decreasing such markers by reducing stress and emotional reactions.

Many studies have demonstrated that MBI can improve psychophysical symptoms (i.e., stress, anxiety, depression, sleep disturbances, and pain) and pro-inflammatory markers (i.e., CRP, IL-6, and TNF α) in different psychiatric and medical populations (Aliche & Onyishi, 2020; Black & Slavich, 2016; Chu et al., 2021). A few studies have examined MBI's effects on limited numbers of psychophysical symptoms in ESRD patients undergoing hemodialysis, but they were hampered by severe limitations, such as small sample sizes and unstandardized intervention protocols.

For example, five weekly sessions of MBI improved perceived stress and QoL through the development of emotional regulation in patients undergoing hemodialysis (Alhawatmeh et al., 2022). Evidence has also shown that the practice of MBI reduced sleep disturbances, anxiety, stress, and depression in such patients (Alhawatmeh et al., 2022; Hackett & Jardine, 2017; Nejad et al., 2018). An extensive literature search did not find any previous study that examined the impact of MBI on serum proinflammatory biomarkers in patients with ESRD undergoing hemodialysis, although such interventions reduced proinflammatory markers such as CRP, interleukin-6 and TNF in different clinical conditions such as cancer, rheumatoid arthritis, and ulcerative colitis (Black & Slavich, 2016). Thus, the goal of this research is to investigate the effect of MBI on physical and psychological symptoms (e.g., stress, anxiety and depression) and proinflammatory biomarkers (e.g., TNF and CRP) in patients with ESRD undergoing hemodialysis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Masking Description

A research assistant who did not participate in the other study phases collected the data, including blood sampling.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with ESRD who underwent hemodialysis thrice weekly
  • •were at least 18 years old
  • •were capable of reading and writing in Arabic
  • •agreed to participate.

Exclusion Criteria

  • •Patients under total parenteral nutrition (TPN)
  • •undergoing psychotherapy
  • •taking psychopharmacological or anti-inflammatory drugs
  • •having immunocompromised and infectious illnesses

Arms & Interventions

Patients with ESRD receiving mindfulness-based intervention

Experimental

Patients with ESRD who received mindfulness-based intervention: underwent hemodialysis thrice weekly, were at least 18 years old, were capable of reading and writing in Arabic, and agreed to participate. Patients under total parenteral nutrition (TPN), undergoing psychotherapy, taking psychopharmacological or anti-inflammatory drugs, and having immunocompromised and infectious illnesses were excluded from the research.

Intervention: Mindfulness-based intervention (Behavioral)

Control group

No Intervention

The control group including patients with ESRD with the inclusion criteria similar to the experimental group received usual care, comprising biomedical normative dialysis treatment (the participants in this group did not receive any kind of additional treatment or holistic components). However, upon completion of the study, audio recordings of the intervention protocol were provided and explained to participants in the control group.

Outcomes

Primary Outcomes

Tumor necrosis factor-alpha

Time Frame: 8 weeks

This biomarker were analyzed using the ELISA protocol

Depression, Anxiety and Stress Scale (DASS-21)

Time Frame: 8 weeks

Depression, Anxiety and Stress Scale (DASS-21) was used to assess emotional symptoms (Antony et al., 1998). Each item is answered with a rating from 0 to 3, where 0 indicates "Did not apply to me", and 3 indicates "Applied to me most of the time". Total scores are calculated by summing the scores for the relevant items and then multiplying them by 2. The total scores for each subscale range from 0 to 42. Higher scores on the DASS-21 indicate a higher level of symptoms

C-reactive protein

Time Frame: 8 weeks

Serum CRP: This biomarker was analyzed using the ELISA protocol

Interleukin 6

Time Frame: 8 weeks

This biomarker was analyzed using the ELISA protocol

Mindful Attention Awareness Scale (MAAS-15)

Time Frame: 8 weeks

Mindful Attention Awareness Scale (MAAS-15) was used to assess dispositional mindfulness (Brown \& Ryan, 2003). It includes 15 items measured on a six-point Likert-type scale, ranging from "almost always" (1) to "almost never" (6). The total score of the scale ranges from 15 to 90, with higher scores indicating a higher level of trait mindfulness. It is one-dimensional scale including 15 items measured on a six-point likert type scale, ranging from 1 (almost always) to 6 (almost never). The score range is between 15 and 90, with higher score indicting higher levels of mindfulness.

Patient Health Questionnaire (PHQ-15)

Time Frame: 8 weeks

Patient Health Questionnaire (PHQ-15) was used to measures the severity of 15 somatic symptoms (Kroenke et al., 2002). The PHQ-15 has a total score range of 0 to 30, whereby higher PHQ-15 scores are associated with more frequent and severe physical symptoms (Kroenke, et al., 2002)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hossam Najjem Alhawatmeh

Associate professor

Jordan University of Science and Technology

Study Sites (2)

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