Effect of PMR on Pain In Patients With ESRD

NCT07061028 | Completed

• 1 other identifier: 2024/136
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Patients with chronic end-stage renal disease (ESRD) commonly experience chronic pain, which significantly impair their quality of life. This pain is often exacerbated by maladaptive cognitive appraisals, in particular pain catastrophizing. This study investigated the effectiveness of progressive muscle relaxation (PMR) on pain intensity, pain catastrophizing, and health-related quality of life on patients undergoing with ESRD. Methods: This randomized controlled parallel study was conducted in a governmental hospital in Jordan in 2024. Participants (N= 104) were randomly assigned to an experimental group offered five sessions of 30 minutes of PMR per week over a total period of five weeks and a control group, which receives standard treatment. The outcomes were measured by Arabic validated scales such as the Pain Catastrophizing Scale, Numerical Pain Rating Scale and the Renal Disease Quality of Life questionnaire at baseline and the end of the intervention.

Conditions

End Stage Renal Disease (ESRD)

Keywords

Progressive Muscle Relaxation; End Stage Kidney Disease; Pain; Pain Catastrophizing; Quality of Life

Outcome Measures

Primary Outcomes (3)

• The Arabic Pain Catastrophizing Scale

  The Arabic Pain Catastrophizing Scale (PCS) was used to measure pain catastrophizing in the study. It consists of 13 items that evaluate an individual's thoughts and emotions connected to pain. Three aspects of pain catastrophizing are measured by PCS: helplessness (6 items) magnification (3 items) and rumination (4 items). Patients rate how often they experience the above thoughts and sensations when they are in pain. They use a 5-point Likert-type scale, ranging from 0 (not at all) 1 to 4 (all the time). By adding together, the scores for each question, one may get the subscale scores. These scores are between 0 to 52, with higher scores are indicative of a greater pain catastrophizing. A reliable and valid method for assessing catastrophizing in chronic pain patients who speak Arabic is the Arabic version of the Pain Catastrophizing Scale (PCS). The scale demonstrated strong internal consistency, with a Cronbach's α of 0.94.

  From enrollment to the end of treatment at 6 weeks

• Visual Analog Scale (VAS)

  The scale asks respondents to select the value (between 0 and 10) which most closely represents their level of pain. High test-retest reliability has been demonstrated by both literate and illiterate rheumatoid arthritis patients (r = 0.96 and 0.95, respectively). With correlation ranging from 0.86 to 0.95, the NPRS was found to have a strong association with the VAS for construct validity among individuals with chronic pain disorders (pain that lasts a minimum of six months). The scale has been found to be a valid and reliable tool for assessing pain severity in Arabic-speaking nations.

  From enrollment to the end of intervention at 6 weeks

• Arabic version of the kidney disease-related Quality of Life questionnaire

  Quality of life was assessed using the Arabic version of the kidney disease-related Quality of Life questionnaire (KDQOL-36). It comprises four subscales: generic core \[Physical Component Summary (PCS, 12 items) and mental component summary (MCS, 12 items); symptoms and issues (12 items); burden of renal disease (4 items); and impacts of kidney disease (8 items) (Elamin et al., 2019). The raw, pre-coded numerical values of each item are linearly transformed into a scale ranging from 0 to 100, where higher numbers denote a higher quality of life. Positive psychometric characteristics were found in Arabic patients with chronic renal insufficiency using the scale's Arabic version. With a Cronbach's alpha of 0.81, the KDQOL-36 translation demonstrated high internal reliability.

  From enrollment to the end of intervention at 6 weeks

Study Arms (2)

Progressive Muscle Relaxation

EXPERIMENTAL

This group received five weekly 30-minute sessions of Progressive Muscle Relaxation (PMR) based on the ABC relaxation theory. The PMR protocol developed by Smith (2005) involve tense-and-release exercises for 11 different muscle groups, including hands, arms, sides, back, shoulders, face, neck, stomach, chest, legs, and feet. For five to ten seconds, each muscle group is contracted, and for twenty to thirty seconds, it is relaxed. The sensations of stress and relaxation were the participants' main concern. To release any residual tension, they looked at each muscle group after the workout. With the exception of the time needed for measurements and instructions, the entire operation took roughly thirty minutes.

Behavioral: Progressive Muscle Relaxation

Waitlist Control Group

OTHER

The control group received no intervention from the researcher during the study. However, following the intervention, the control group participants were given the audio recordings of the intervention protocol along with an explanation of them.

Other: Control Group

Interventions

Progressive Muscle Relaxation BEHAVIORAL

This intervention involves five weekly 30-minute sessions of Progressive Muscle Relaxation (PMR) based on the ABC relaxation theory. The PMR protocol developed by Smith (2005) involve tense-and-release exercises for 11 different muscle groups, including hands, arms, sides, back, shoulders, face, neck, stomach, chest, legs, and feet. For five to ten seconds, each muscle group is contracted, and for twenty to thirty seconds, it is relaxed. The sensations of stress and relaxation were the participants' main concern. To release any residual tension, they looked at each muscle group after the workout. With the exception of the time needed for measurements and instructions, the entire operation took roughly thirty minutes.

Progressive Muscle Relaxation

Control Group OTHER

The control group received no intervention from the researcher during the study. However, following the intervention, the control group participants were given the audio recordings of the intervention protocol along with an explanation of them.

Waitlist Control Group

Eligibility Criteria

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

You may qualify if:

• The patients with ESRD who had a smartphone
• aged eighteen years or above
• and received hemodialysis at least thrice a week

You may not qualify if:

• The patients with ESRD patients who received psychotherapy
• or took regular psychopharmacological and analgesic treatment

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology/ King Abdullah University Hospital

Irbid, 22110, Jordan

Location

Related Publications (19)

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

  BACKGROUND

• Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 7(4), 524-532. https://doi.org/10.1037/1040-3590.7.4.524

  BACKGROUND

• Terkawi AS, Sullivan M, Abolkhair A, Al-Zhahrani T, Terkawi RS, Alasfar EM, Khait SSA, Elkabbani A, Kabbani N, Altirkawi KA, Tsang S. Development and validation of Arabic version of the pain catastrophizing scale. Saudi J Anaesth. 2017 May;11(Suppl 1):S63-S70. doi: 10.4103/sja.SJA_130_17.

  PMID: 28616005 BACKGROUND

• Zhang C, Zhang Z, Li Y, Feng C, Meng H, Gao Y, Lo WLA, Wang C. Pain Catastrophizing Is Related to Static Postural Control Impairment in Patients with Nonspecific Chronic Low Back Pain: A Cross-Sectional Study. Pain Res Manag. 2020 Oct 28;2020:9629526. doi: 10.1155/2020/9629526. eCollection 2020.

  PMID: 33193926 BACKGROUND

• Wolff B, Burns JW, Quartana PJ, Lofland K, Bruehl S, Chung OY. Pain catastrophizing, physiological indexes, and chronic pain severity: tests of mediation and moderation models. J Behav Med. 2008 Apr;31(2):105-14. doi: 10.1007/s10865-007-9138-z.

  PMID: 18158618 BACKGROUND

• Kesik G, Ozdemir L, Mungan Ozturk S. The Effects of Relaxation Techniques on Pain, Fatigue, and Kinesiophobia in Multiple Sclerosis Patients: A 3-Arm Randomized Trial. J Neurosci Nurs. 2022 Apr 1;54(2):86-91. doi: 10.1097/JNN.0000000000000620.

  PMID: 35149625 BACKGROUND

• Kazak A, Ozkaraman A. The Effect of Progressive Muscle Relaxation Exercises on Pain on Patients with Sickle Cell Disease: Randomized Controlled Study. Pain Manag Nurs. 2021 Apr;22(2):177-183. doi: 10.1016/j.pmn.2020.02.069. Epub 2020 Mar 26.

  PMID: 32224022 BACKGROUND

• Karakus A, Uzelpasaci E, Akyurek G. The comparative effectiveness of progressive relaxation training on pain characteristics, attack frequency, activity self-efficacy, and pain-related disability in women with episodic tension-type headache and migraine. PLoS One. 2025 Apr 28;20(4):e0320575. doi: 10.1371/journal.pone.0320575. eCollection 2025.

  PMID: 40293994 BACKGROUND

• Kaplan Serin E, Ovayolu N, Ovayolu O. The Effect of Progressive Relaxation Exercises on Pain, Fatigue, and Quality of Life in Dialysis Patients. Holist Nurs Pract. 2020 Mar/Apr;34(2):121-128. doi: 10.1097/HNP.0000000000000347.

  PMID: 31567304 BACKGROUND

• Izgu N, Gok Metin Z, Karadas C, Ozdemir L, Metinarikan N, Corapcioglu D. Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue, and Quality of Life in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J Nurs Scholarsh. 2020 Sep;52(5):476-487. doi: 10.1111/jnu.12580. Epub 2020 Jun 13.

  PMID: 32536026 BACKGROUND

• He CC, Lin DM, Liu HZ, Wang FF, Guo XF, Zhang XB, Ai YQ, Meng LM. Nonpharmacological Interventions for Management of the Pain-Fatigue-Sleep Disturbance Symptom Cluster in Breast Cancer Patients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2023 Aug 7;16:2713-2728. doi: 10.2147/JPR.S409798. eCollection 2023.

  PMID: 37577159 BACKGROUND

• Fonseca das Neves J, Kornacka M, Serra E, Rollin N, Kosinski T, Marechal V, Jehel L, Rusinek S. The impact of rumination on fibromyalgia pain after physical activity: an experimental study. Sci Rep. 2023 Nov 22;13(1):20523. doi: 10.1038/s41598-023-47414-z.

  PMID: 37993555 BACKGROUND

• Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.

  PMID: 2213777 BACKGROUND

• Feldmann M, Hein HJ, Voderholzer U, Doerr R, Hoff T, Langs G, Herzog P, Kaiser T, Rief W, Riecke J, Brakemeier EL. Cognitive Change and Relaxation as Key Mechanisms of Treatment Outcome in Chronic Pain: Evidence From Routine Care. Front Psychiatry. 2021 Aug 3;12:617871. doi: 10.3389/fpsyt.2021.617871. eCollection 2021.

  PMID: 34413794 BACKGROUND

• Dikmen HA, Terzioglu F. Effects of Reflexology and Progressive Muscle Relaxation on Pain, Fatigue, and Quality of Life during Chemotherapy in Gynecologic Cancer Patients. Pain Manag Nurs. 2019 Feb;20(1):47-53. doi: 10.1016/j.pmn.2018.03.001. Epub 2018 Dec 13.

  PMID: 29776873 BACKGROUND

• Darnall BD, Carr DB, Schatman ME. Pain Psychology and the Biopsychosocial Model of Pain Treatment: Ethical Imperatives and Social Responsibility. Pain Med. 2017 Aug 1;18(8):1413-1415. doi: 10.1093/pm/pnw166. No abstract available.

  PMID: 27425187 BACKGROUND

• Al Hasbi, H., Chayati, N., & Makiyah, S. N. N. (2019). Progressive muscle relaxation to reduces chronic pain in hemodialysis patient. MEDISAINS: Jurnal Ilmiah Ilmu-Ilmu Kesehatan, 17(3), 62-66.

  BACKGROUND

• Elamin S, E Elbasher AH, E Ali SE, Abu-Aisha H. Arabic translation, adaptation, and validation of the kidney disease quality of life short-form 36. Saudi J Kidney Dis Transpl. 2019 Nov-Dec;30(6):1322-1332. doi: 10.4103/1319-2442.275476.

  PMID: 31929279 BACKGROUND

• Alhawatmeh H, Albataineh R, Abuhammad S. Differential effects of guided imagery and progressive muscle relaxation on physical and emotional symptoms in nursing students taking initial clinical training: A randomized clinical trial. Heliyon. 2022 Oct 19;8(10):e11147. doi: 10.1016/j.heliyon.2022.e11147. eCollection 2022 Oct.

  PMID: 36311359 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Pain

Interventions

Autogenic Training; Control Groups

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; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Peofessor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: February 1, 2024
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)