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

Not Applicable

• Conditions: Chronic Pain
• Interventions: Other: MBSR and physiotherapy; Other: physiotherapy

• Registration Number: NCT06547723
• Lead Sponsor: Mohammad Soukhtanlou

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-11-01
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	MBSR and physiotherapy	Participants in the experimental group receive 20 sessions physiotherapy (in first-4-week, three sessions and next-4-week two sessions on a weekly basis) along with one MBSR session (total MBSR sessions are eight sessions), which also include regular MBSR homework.
control group	physiotherapy	Participants in the control group receive 20 sessions physiotherapy (in first-4-week, three sessions and next-4-week two sessions on a weekly basis).

Primary Outcome Measures

Name	Time	Method
The Numerical Rating Scale-11 (NRS-11).	At the baseline, immediately after last session, and 3-month follow-up.	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").
. The Patient Global Assessment of Treatment Satisfaction (PGATS)	At the baseline, immediately after last session, and 3-month follow-up.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bahar physiotherapy clinic; 🇮🇷 Mashhad, Razavi-khorasan, Iran, Islamic Republic of