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

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pain
• Intervention / Treatment: Other: MBSR and physiotherapy; Other: physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Razavi-khorasan
    • Mashhad, Razavi-khorasan, Iran, Islamic Republic of, 9188856473
      • Bahar physiotherapy clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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.	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 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.
Active Comparator: control group; 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).	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), 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. 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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mohammad Soukhtanlou
• Investigators: Study Chair: Reza poorhosein, PhD, Faculty of Psychology and Education, the University of Tehran.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): February 10, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Chronic pain; Physiotherapy; Mindfulness-based stress reduction program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: UTehran

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to the results of the data starts simultaneously with the publication of an article based on them and presenting all the information in the doctoral thesis of the main researcher in 2024. The release of the raw data will be one year after the publication of the results, although the ethics committees and the doctoral thesis advising committee will have access to all the data at all stages.
• IPD Sharing Time Frame: 1 year after manuscript publication.
• IPD Sharing Access Criteria: The data will be sent only to experts working in academic environments who have researches in line with the field of this study according to their request.To receive the data, one email should be send to corresponded author of this research.
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No