The Impact of Mindfulness-Based Intervention on Psychophysical Health

NCT06064708 | Completed

• 1 other identifier: 34/156/2023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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).

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Inflammatory Cytokines; Mindfulness-based intervention

Outcome Measures

Primary Outcomes (6)

• C-reactive protein

  Serum CRP: This biomarker was analyzed using the ELISA protocol

  8 weeks

• Interleukin 6

  This biomarker was analyzed using the ELISA protocol

  8 weeks

• Tumor necrosis factor-alpha

  This biomarker were analyzed using the ELISA protocol

  8 weeks

• Mindful Attention Awareness Scale (MAAS-15)

  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.

  8 weeks

• Depression, Anxiety and Stress Scale (DASS-21)

  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

  8 weeks

• Patient Health Questionnaire (PHQ-15)

  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)

  8 weeks

Study Arms (2)

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.

Behavioral: Mindfulness-based intervention

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.

Interventions

Mindfulness-based intervention BEHAVIORAL

The experimental group received 30 minutes of MBI according to Smith's (2005) MBI protocol, which is a standardized theory-based intervention. Smith's (2005) MBI protocol comprises six components: 1. Being mindful of the breath (5 minutes). 2. Being mindful of the body (5 minutes). 3. Being mindful of the thought (5 minutes) 4. Being mindful of the sound (5 minutes) 5. Being mindful during walking (5 minutes) 6. Full meditation (5 minutes).

Patients with ESRD receiving mindfulness-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (2)

Hossam AlHawatmeh

Irbid, None Selected, 22110, Jordan

Location

Jordan University of Science and Technology

Irbid, None Selected, 22110, Jordan

Location

Related Publications (19)

• Finnegan-John J, Thomas VJ. The psychosocial experience of patients with end-stage renal disease and its impact on quality of life: findings from a needs assessment to shape a service. ISRN Nephrol. 2012 Oct 21;2013:308986. doi: 10.5402/2013/308986. eCollection 2013.

  PMID: 24959536 BACKGROUND

• Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.

  PMID: 26799456 BACKGROUND

• Hackett ML, Jardine MJ. We Need to Talk about Depression and Dialysis: but What Questions Should We Ask, and Does Anyone Know the Answers? Clin J Am Soc Nephrol. 2017 Feb 7;12(2):222-224. doi: 10.2215/CJN.13031216. Epub 2017 Jan 26. No abstract available.

  PMID: 28126705 BACKGROUND

• Hintistan, S., & Deniz, A. (2018). Cite this article as: Hintistan S, Deniz A. Evaluation of Symptoms in Patients Undergoing Hemodialysis. Bezmialem Science, 6, 112-120. https://doi.org/10.14235/bs.2018.1530

  BACKGROUND

• Vasilopoulou C, Bourtsi E, Giaple S, Koutelekos I, Theofilou P, Polikandrioti M. The Impact of Anxiety and Depression on the Quality of Life of Hemodialysis Patients. Glob J Health Sci. 2015 May 17;8(1):45-55. doi: 10.5539/gjhs.v8n1p45.

  PMID: 26234986 BACKGROUND

• Maydych V. The Interplay Between Stress, Inflammation, and Emotional Attention: Relevance for Depression. Front Neurosci. 2019 Apr 24;13:384. doi: 10.3389/fnins.2019.00384. eCollection 2019.

  PMID: 31068783 BACKGROUND

• Abdel-Messeih PL, Alkady MM, Nosseir NM, Tawfik MS. Inflammatory markers in end-stage renal disease patients on haemodialysis. J Med Biochem. 2020 Oct 2;39(4):481-487. doi: 10.5937/jomb0-25120.

  PMID: 33312065 BACKGROUND

• Chu SWF, Yeam CT, Low LL, Tay WY, Foo WYM, Seng JJB. The role of mind-body interventions in pre-dialysis chronic kidney disease and dialysis patients - A systematic review of literature. Complement Ther Med. 2021 Mar;57:102652. doi: 10.1016/j.ctim.2020.102652. Epub 2020 Dec 26.

  PMID: 33373760 BACKGROUND

• Aliche JC, Onyishi IE. Mindfulness and wellbeing in older adults' survivors of herdsmen attack. The mediating effect of positive reappraisal. Aging Ment Health. 2020 Jul;24(7):1132-1140. doi: 10.1080/13607863.2019.1602592. Epub 2019 Apr 24.

  PMID: 31016997 BACKGROUND

• Moosavi Nejad M, Shahgholian N, Samouei R. The effect of mindfulness program on general health of patients undergoing hemodialysis. J Educ Health Promot. 2018 Jun 12;7:74. doi: 10.4103/jehp.jehp_132_17. eCollection 2018.

  PMID: 29963567 BACKGROUND

• Smith, J. (2005). Relaxation, meditation, & mindfulness: A mental health practitioner's guide to new and traditional approaches. https://books.google.com/books?hl=en&lr=&id=RCLr6ap7vRgC&oi=fnd&pg=PP11&dq=Smith,+J.+C.+(2005).+Relaxation,+meditation,+and+mindfulness:+A+mental+health+practitioner's+guide+to+new+and+traditional+approaches.+New+York,+NY,+Springer+Publishing+Co.&ots=vN4OeJpowy&sig=CZBq7fwjjxGVWb3139NndQtQ-xw

  BACKGROUND

• Alhawatmeh H, Alshammari S, Rababah JA. Effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in hemodialysis patients: A randomized controlled trial. Int J Nurs Sci. 2022 Mar 8;9(2):139-146. doi: 10.1016/j.ijnss.2022.03.004. eCollection 2022 Apr.

  PMID: 35509694 BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 BACKGROUND

• AlHadi AN, AlAteeq DA, Al-Sharif E, Bawazeer HM, Alanazi H, AlShomrani AT, Shuqdar RM, AlOwaybil R. An arabic translation, reliability, and validation of Patient Health Questionnaire in a Saudi sample. Ann Gen Psychiatry. 2017 Sep 6;16:32. doi: 10.1186/s12991-017-0155-1. eCollection 2017.

  PMID: 28878812 BACKGROUND

• Igarashi NS, Karam CH, Afonso RF, Carneiro FD, Lacerda SS, Santos BF, Kozasa EH, Rangel EB. The effects of a short-term meditation-based mindfulness protocol in patients receiving hemodialysis. Psychol Health Med. 2022 Jul;27(6):1286-1295. doi: 10.1080/13548506.2021.1871769. Epub 2021 Jan 15.

  PMID: 33449820 BACKGROUND

• Al-Dwaikat TN, Rababah JA, Al-Hammouri MM, Chlebowy DO. Social Support, Self-Efficacy, and Psychological Wellbeing of Adults with Type 2 Diabetes. West J Nurs Res. 2021 Apr;43(4):288-297. doi: 10.1177/0193945920921101. Epub 2020 May 16.

  PMID: 32419665 BACKGROUND

• Alhawatmeh H, Najadat I, Hweidi I, Abuhammad S. The impact of mindfulness meditation on pro-inflammatory biomarkers in patients with end-stage renal disease: A randomized trial. SAGE Open Med. 2024 Dec 18;12:20503121241308995. doi: 10.1177/20503121241308995. eCollection 2024.

  PMID: 39713266 DERIVED

• Alhawatmeh H, Najadat IA, Hweidi IM. Mindfulness-based intervention as a symptom management strategy in patients with end-stage renal disease: A controlled clinical trial. Int J Nurs Pract. 2024 Dec;30(6):e13282. doi: 10.1111/ijn.13282. Epub 2024 Jun 16.

  PMID: 38880954 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A research assistant who did not participate in the other study phases collected the data, including blood sampling.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: the participants were randomly distributed into the experimental and control groups according to a straightforward 1:1 computer-generated sequence, giving them an equal chance of being in either of the two groups.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: April 10, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 30, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)