MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly

Official title

Developing and Compiling a Mindfulness-Based Stress Reduction Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly

Overview

It has been shown that MBSR could be effective in different types of chronic pain in geriatrics, but more evidence in the interdisciplinary context is needed. This study is conducted to develop and compile a mindfulness-based stress reduction (MBSR) program within a context of physiotherapy rehabilitation to manage chronic pain in the elderly in an Iranian clinical setting. The 8-session MBSR treatment protocol was translated, revised for the Iranian elderlies, and compiled as a one-on-one therapy using a unique protocol with 20-session physiotherapy. 40 volunteers aged 65 or more with musculoskeletal chronic pain will be selected and receive the program for 8 consecutive weeks with a 3-month follow-up. Treatment satisfaction levels, adherence to treatment sessions, and patient-reported clinical outcome measures were used at baseline, immediately post-intervention, and three months following the intervention, measuring pain, anxiety, fatigue, sleep disturbance, pain interference levels, and kinesiophobia.

Interventions

• Other MBSR and physiotherapy
  In experimental group in the first session, the research program and plans for outcome assessment will be introduced. They will sign the research agreement form and will be interviewed to obtain information about their pain, their medication(s), and demographics. This will be followed by the first 70-80-minute physiotherapy session. During each session, the physiotherapist will administer the Transcutaneous electrical nerve stimulation (TENS), low-level laser therapy (LLLT), and ultrasound thera
• Other physiotherapy
  In control group in the first session, the research program and plans for outcome assessment will be introduced. The participants then will sign the research agreement form and will be interviewed to obtain information about their pain (i.e., duration, location, and course), their medication(s), and demographics. This will be followed by the first 70-80-minute physiotherapy session. During each session, the physiotherapist will administer the Transcutaneous electrical nerve stimulation (TENS), l

Primary outcome measures

• . The Patient Global Assessment of Treatment Satisfaction (PGATS) [Time frame: At the baseline, immediately after last session, and 3-month follow-up.]
• The Numerical Rating Scale-11 (NRS-11). [Time frame: At the baseline, immediately after last session, and 3-month follow-up.]

Secondary outcome measures (2)

• The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0). [Time frame: At the baseline, immediately after last session, and 3-month follow-up.]
• The Tampa Scale Kinesiophobia (TKS-11). [Time frame: At the baseline, immediately after last session, and 3-month follow-up.]

Eligibility criteria

Inclusion criteria

• Aged 65 or more
• Have chronic pain
• Have ability of reading and writing in Persian
• Visiting the clinic in which the study was took place

Exclusion criteria

• Dose not have any diagnosed Cognitive Impairment
• Failure to approve the consent form

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Iran · 1 center

• Bahar physiotherapy clinic — Mashhad

Identifiers

NCT: NCT06547723 · UTehran

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗