MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
NCT ID: NCT06547723
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
40 participants
INTERVENTIONAL
2024-03-15
2025-02-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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.
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).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Have chronic pain
* Have ability of reading and writing in Persian
* Visiting the clinic in which the study was took place
Exclusion Criteria
* Failure to approve the consent form
65 Years
90 Years
ALL
No
Sponsors
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Mohammad Soukhtanlou
OTHER
Responsible Party
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Mohammad Soukhtanlou
Mohammad Soukhtanlou M.Sc.
Principal Investigators
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Reza poorhosein, PhD
Role: STUDY_CHAIR
Faculty of Psychology and Education, the University of Tehran.
Locations
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Bahar physiotherapy clinic
Mashhad, Razavi Khorasan Province, Iran
Countries
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Other Identifiers
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UTehran
Identifier Type: -
Identifier Source: org_study_id
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