PMR vs MM for Patients on Hemodialysis

NCT06625125 | Not Yet Recruiting

• 1 other identifier: 2024/369
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hemodialysis is considered as an effective therapy to remove harmful waste 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. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) are effective mind-body connection programs that are inadequately used in patients undergoing hemodialysis. Objectives: This study will examine the differential effects of mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) on expression suppression, cognitive reappraisal, and perceived Stress in Patients with End-Stage Renal Disease undergoing hemodialysis in Jordan. Methods: An experimental parallel control, randomized design will be implemented among 159 PwESRD undergoing hemodialysis in a big referral Hospital in Jordan. Simple random assignation will be used to create three equal groups including PMR, MBI, and control groups (N= each). Both groups will practice their assigned intervention over five weeks (with three half-hour sessions per week) during hemodialysis sessions. The study variables will be measured for the three groups at the outset and eight weeks after initiation. Variables will be measured by the self-reporting questionnaire including sociodemographic characteristic sheet, the Mindfulness attention awareness scale (MAAS) the Perceived Stress Scale (PSS), and the Emotion Regulation Questionnaire (ERQ). Repeated measures analysis of variance (RM ANOVA) will be used to analyze the main study data.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; End stage renal disease; Mindfulness meditation; Progressive muscle relaxation; Cognitive reappraisal; Behavioral suppression; Perceived stress

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale (PSS)

  An Arabic version of the Perceived Stress Scale (PSS) was used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded) (Almadi, et al., 2012). It includes 10 items measured on a 5-point Likert scale (0=never, 4= very often), which are relatively free of content specific to any subpopulation group. The scores range from 0 to 40 with higher score indicating higher levels of perceived stress (stressful appraisal) (Cohen, et al., 1983). PSS has been validated for use with college students. Internal consistency coefficients for the PSS ranged from .84 to 36, and test- retest reliability is .85 (Cohen et al., 1983). The Arabic Perceived Stress Scale showed adequate reliability and validity and considered a suitable instrument to assess perceived stress in Arabic people (Almadi et al., 2012).

  From enrollment to the end of treatment at 8 weeks

• Emotion Regulation Questionnaire (ERQ)

  An Arabic version of ERQ will be used to measure emotion regulation abilities including cognitive reappraisal and expression suppression. The questionnaire is a 7-point Likert-type scale, with two subscales including cognitive reappraisal (6 items) and expressive suppression (4 items). The scale items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The higher scores indicate greater emotion regulation abilities such as cognitive reappraisal and expressive suppression (Gross \& John, 2003). Arabic version showed valid and reliable results among Arabic Gulf population and Jordanian patients with ESRD (Alhawatmeh et al. 2022; Keshky, 2018).

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• The Mindful Attention Awareness Scale (MAAS)

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Patients with ESRD receiving mindfulness-based intervention

EXPERIMENTAL

The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. (Smith, 2005). The subjects in the mindfulness-based intervention (MBI) group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (Alhawatmeh et al., 2022; Thomas et al., 2017). Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's MBI protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Behavioral: Mindfulness-based intervention

Patients with ESRD receiving progressive muscle relaxation

ACTIVE COMPARATOR

The progressive muscle relaxation (PMR) group will receive the ABC version of PMR (Smith, 2005). This abbreviated version of PMR involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. As the MBI group, the subjects in the PMR group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks. Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's PMR protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Behavioral: Progressive muscle relaxation

Patients with ESRD receiving the hospital traditional care

NO INTERVENTION

The control group will not receive any intervention from the study researchers

Interventions

Mindfulness-based intervention BEHAVIORAL

The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. (Smith, 2005). The subjects in the mindfulness-based intervention (MBI) group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (Alhawatmeh et al., 2022; Thomas et al., 2017). Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's MBI protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Patients with ESRD receiving mindfulness-based intervention

Progressive muscle relaxation BEHAVIORAL

he progressive muscle relaxation (PMR) group will receive the ABC version of PMR (Smith, 2005). This abbreviated version of PMR involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. As the MBI group, the subjects in the PMR group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks. Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's PMR protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Patients with ESRD receiving progressive muscle relaxation

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 undergoing hemodialysis at least three sessions a week
• being at least 18 years old
• having a smartphone
• being capable of reading and writing in Arabic

You may not qualify if:

• Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Prince Rashid Military Hospital

Irbid, 22110, Jordan

Location

Related Publications (24)

• 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

• Almadi T, Cathers I, Hamdan Mansour AM, Chow CM. An Arabic version of the perceived stress scale: translation and validation study. Int J Nurs Stud. 2012 Jan;49(1):84-9. doi: 10.1016/j.ijnurstu.2011.07.012. Epub 2011 Aug 17.

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• Beevers, C. G., Wenzlaff, R. M., Hayes, A. M., & Scott, W. D. (1999). Depression and the ironic effects of thought suppression: Therapeutic strategies for improving mental control. Clinical Psychology: Science and Practice, 6,133-148

  BACKGROUND

• Bennett PN, Ngo T, Kalife C, Schiller B. Improving wellbeing in patients undergoing dialysis: Can meditation help? Semin Dial. 2018 Jan;31(1):59-64. doi: 10.1111/sdi.12656. Epub 2017 Nov 2.

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• Carmody, J. (2009). Evolving conceptions of mindfulness in clinical settings. Journal of Cognitive Psychotherapy, 23, 270-280.

  BACKGROUND

• Chambers R, Gullone E, Allen NB. Mindful emotion regulation: An integrative review. Clin Psychol Rev. 2009 Aug;29(6):560-72. doi: 10.1016/j.cpr.2009.06.005. Epub 2009 Jun 23.

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• 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.

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• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

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• Dehghan M, Namjoo Z, Bahrami A, Tajedini H, Shamsaddini-Lori Z, Zarei A, Dehghani M, Ranjbar MS, Rafiee Sarbijan Nasab F. The use of complementary and alternative medicines, and quality of life in patients under hemodialysis: A survey in southeast Iran. Complement Ther Med. 2020 Jun;51:102431. doi: 10.1016/j.ctim.2020.102431. Epub 2020 May 21.

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• Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.

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• Garland EL, Roberts RL, Hanley AW, Zeidan F, Keefe FJ. The Mindful Reappraisal of Pain Scale (MRPS): Validation of a New Measure of Psychological Mechanisms of Mindfulness-Based Analgesia. Mindfulness (N Y). 2023 Jan;14(1):192-204. doi: 10.1007/s12671-022-02034-y. Epub 2022 Dec 16.

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• Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

  PMID: 12916575 BACKGROUND

• Keshky, M. E. E. (2018). Keshky ME. Factor Structure, Reliability and Validity of the Arabic Version of the Emotion Regulation Questionnaire (ERQ) in a Sample of Saudi Children and Adolescents. International Journal of Psychology and Behavioral Sciences. 2018;8(2):22-30.

  BACKGROUND

• Kabat-Zinn, J. (1990). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. PsycCRITIQUES, 37(6), 609-609. https://doi.org/10.1037/032287

  BACKGROUND

• Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10.

  PMID: 18329323 BACKGROUND

• Nassim M, Park H, Dikaios E, Potes A, Elbaz S, Mc Veigh C, Lipman M, Novak M, Trinh E, Alam A, Suri RS, Thomas Z, Torres-Platas S, Vasudev A, Sasi N, Gautier M, Mucsi I, Noble H, Rej S. Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial. Healthcare (Basel). 2021 Jun 1;9(6):659. doi: 10.3390/healthcare9060659.

  PMID: 34205915 BACKGROUND

• Parmentier FBR, Garcia-Toro M, Garcia-Campayo J, Yanez AM, Andres P, Gili M. Mindfulness and Symptoms of Depression and Anxiety in the General Population: The Mediating Roles of Worry, Rumination, Reappraisal and Suppression. Front Psychol. 2019 Mar 8;10:506. doi: 10.3389/fpsyg.2019.00506. eCollection 2019.

  PMID: 30906276 BACKGROUND

• Ray RD, McRae K, Ochsner KN, Gross JJ. Cognitive reappraisal of negative affect: converging evidence from EMG and self-report. Emotion. 2010 Aug;10(4):587-92. doi: 10.1037/a0019015.

  PMID: 20677875 BACKGROUND

• Saleh, W., Maani, N., & Sharkas, G. (2020). The Hashemite Kingdom of Jordan Ministry of Health 13th annual report. Ministry of Health.

  BACKGROUND

• Smith, J. C. (2005). Relaxation, meditation, & mindfulness: A mental health practitioner's guide to new and traditional approaches. Springer Publishing Company.

  BACKGROUND

• Thomas Z, Novak M, Platas SGT, Gautier M, Holgin AP, Fox R, Segal M, Looper KJ, Lipman M, Selchen S, Mucsi I, Herrmann N, Rej S. Brief Mindfulness Meditation for Depression and Anxiety Symptoms in Patients Undergoing Hemodialysis: A Pilot Feasibility Study. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2008-2015. doi: 10.2215/CJN.03900417. Epub 2017 Oct 12.

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• Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.

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MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Autogenic Training

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

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hossam Alhawatmeh

  Hossam alhawatmeh, assistant professor, Jordan university of science and technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossam Alhawatmeh, Ph.D

CONTACT

0797413244; hnhawatmeh@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the participants' random assignment to either the experimental or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)