MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
NCT Number: NCT06547723
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: OTHER: MBSR and physiotherapy|OTHER: physiotherapy
Sponsor: Mohammad Soukhtanlou
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-03-15
Completion Date: 2025-02-10
Locations: Bahar physiotherapy clinic, Mashhad, Razavi-khorasan, 9188856473, Iran, Islamic Republic of

Summary:
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.

Primary Outcome Measures: . The Patient Global Assessment of Treatment Satisfaction (PGATS), Treatment satisfaction was assessed with six questions asking the participants to rate six domains of treatment satisfaction using a 5-point Likert scale ranging from 0 ("Very dissatisfied") to 4 ("Very satisfied"). Specifically, satisfaction with the combined physiotherapy and MBSR protocol, the duration of the entire protocol, the duration of each treatment session, the content of the treatment sessions, and homework assignments were measured using this tool. Participants were also asked to rate their overall satisfaction with the treatment on the same Likert scale., At the baseline, immediately after last session, and 3-month follow-up.|The Numerical Rating Scale-11 (NRS-11)., Average pain intensity in the past week and post-session current pain intensity were assessed at the end of each session using the NRS-11 (0 = "no pain" and 10 = "worst pain imaginable")., At the baseline, immediately after last session, and 3-month follow-up.
Secondary Outcome Measures: The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0)., Physical function, anxiety, depression, fatigue, sleep disturbances, ability to participate in social roles, and pain interference were assessed using the 4-item short form version of the PROMIS-29 v2.0., At the baseline, immediately after last session, and 3-month follow-up.|The Tampa Scale Kinesiophobia (TKS-11)., Fear of movement (i.e., kinesiophobia) was assessed using the brief (11-item) version of the TKS-1. Respondents are asked to indicate agreement with each item on a Likert scale from ("strongly disagree") to 4 ("strongly agree). The items are summed into a total score ranging from 11 to 44. Higher scores indicate a greater fear of movement., At the baseline, immediately after last session, and 3-month follow-up.