The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain

NCT04436705 | Completed

• 1 other identifier: The University of Jordan
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial was designed to evaluate the effectiveness of the Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in patients receiving palliative care in Jordan. The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do not report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer patients receiving palliative care report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate.

Conditions

Cancer-Related Pain

Keywords

Cancer-related pain; Progressive Muscle Relaxation

Outcome Measures

Primary Outcomes (3)

• Cancer-related pain

  Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).

  The BPI assessment was collected at baseline (T0) ( pre-intervention)

• Cancer-related pain

  Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).

  The BPI assessment was collected at the end of PMR technique (4 weeks from T0)

• Cancer-related pain

  Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).

  The BPI assessment was collected at 1-month follow-up (T2)

Study Arms (2)

Progressive Muscle Relaxation (PMR) technique

EXPERIMENTAL

Participants in intervention group continued Progressive Muscle Relaxation (PMR) technique daily for 20 minutes for a total of four weeks addition to usual care. The usual care consists of pharmacological interventions to manage Cancer-related pain.

Other: Progressive Muscle Relaxation (PMR) technique

control

NO INTERVENTION

control group received only usual care for their pain during the study period. The usual care consists of pharmacological interventions to manage Cancer-related pain.

Interventions

Progressive Muscle Relaxation (PMR) technique OTHER

The PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes.

Progressive Muscle Relaxation (PMR) technique

Eligibility Criteria

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

You may qualify if:

• age of 18 years and older
• diagnosed with cancer.
• reported complaints of pain ≥1 on a 0-10 Numerical Rating Scale (NRS) in the 24 hours before recruitment.
• were treated with non-opioid or weak opioid analgesic.
• had a Karnofsky Performance Scale Index ≥ 20.
• had regular access to a telephone.

You may not qualify if:

• a diagnosis of psychiatric illness, central nervous system tumors and musculoskeletal disorders (because these conditions may limit the effectiveness of PMR technique).
• using any type of complementary therapy during the trial period.
• Patients who had no pain and were treated with strong opioid analgesics.

Sponsors & Collaborators

• University of Jordan: lead

Related Publications (1)

• Anshasi H, Saleh M, Abdalrahim MS, Shamieh O. The effectiveness of progressive muscle relaxation technique in reducing cancer-related pain among palliative care patients: A randomized controlled trial. Br J Pain. 2023 Oct;17(5):501-509. doi: 10.1177/20494637231190191. Epub 2023 Jul 18.

  PMID: 38107755 DERIVED

MeSH Terms

Conditions

Cancer Pain

Interventions

Autogenic Training; Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ministry of Health, Amman, Jordan

  MOH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share