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NCT Number: NCT06547723

MBSR 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahar physiotherapy clinic

Mashhad, Razavi Khorasan Province, 9188856473, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR and physiotherapy

Other

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.

Physiotherapy

Other

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.

Primary outcomes

  1. . The Patient Global Assessment of Treatment Satisfaction (PGATS)

    Time frame: 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.

  2. The Numerical Rating Scale-11 (NRS-11).

    Time frame: 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").

Secondary outcomes

  1. 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.

    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.

  2. The Tampa Scale Kinesiophobia (TKS-11).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mohammad Soukhtanlou

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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