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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
40
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 therapy to the painful body region. In addition, they will engage in 20 minutes of exercise during each session. After that, participants will be received their 8 MBSR session with a trained therapist. They will be given their assignments for the week, consisting of the content of that MBSR session. Finally, three months after the last study session, they will be asked to return to the clinic for the follow-up assessment to complete patient-reported outcome measures.
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), low-level laser therapy (LLLT), and ultrasound therapy to the painful body region. In addition, they will engage in 20 minutes of exercise during each session.
Bahar physiotherapy clinic
Mashhad, Razavi Khorasan Province, Iran
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").
Time frame: 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.
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
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.
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
The Patient Global Assessment of Treatment Satisfaction (PGATS)
Description: 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.
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
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