Mindfulness Intervention to Reduce Low Back Pain Among Academicians

NCT ID: NCT06214884

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-07-31

Brief Summary

Mindfulness interventions are a well-known approach for improving mental health. Nevertheless, the available evidence regarding their efficacy in addressing musculoskeletal pain (MSP) is limited, despite numerous studies demonstrating an association between psychological factors and MSP. Both mental health issues and MSP are prevalent among academicians, yet there is a scarce study on the application of mindfulness interventions to these specific concerns. Therefore, this study aimed to provide a study protocol that will focus on assessing the impact of mindfulness interventions on alleviating low back pain (LBP) symptoms, psychological symptoms, and improving work productivity among academic staff.

Detailed Description

This study acknowledges the significance of mindfulness interventions, primarily introduced by Jon Kabat-Zinn. Mindfulness, rooted in various religious traditions, has been associated with improved well-being. The efficacy of mindfulness interventions in addressing anxiety and mood disorders is supported by meta-analyses, indicating moderate effectiveness. The focus then shifts to workplace interventions, noting a rising trend in research on mindfulness from 2012 to 2022. Studies highlight its efficacy not only in mental health aspects among employees but also in reducing musculoskeletal disorders.

Previous studies revealing the positive impact of mindfulness on chronic musculoskeletal pain, psychological well-being, and overall health-related quality of life among nurses. Another study in Denmark combines mindfulness with physical and cognitive elements, demonstrating reductions in pain intensity across various body regions. While mindfulness in the workplace is well-explored, its application in academia, particularly among university teachers, is relatively new. Previous scoping review explores various psychological interventions, including Mindfulness-Based Interventions, cognitive behavioural therapy (CBT), and yoga, to reduce stress and burnout among teachers, but cautions against generalizing these findings to academicians due to the heterogeneity of their work nature.

Based on the fact mentioned above, it is imperative to initiate mindfulness interventions among the academicians targeting to reduce low back pain, psychological symptoms and enhance work productivity. As of our latest information, there are no existing programs accessible for this specific implementation in Malaysia. The specific objectives for this trial were as follows

1. To identify the efficacy of the mindfulness intervention in reducing the pain intensity of LBP among academic staffs.

2. To identify the efficacy of the mindfulness intervention in reducing depression and anxiety symptoms among academic staffs.

3. To identify the efficacy of the mindfulness intervention in improving work productivity among academic staffs.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mindfulness for All (MFA) Group

This intervention program named "MINDFULNESS FOR ALL (MFA)" developed on the conceptual basis of traditional mindfulness programs. Its formal structure resembles the traditional mindfulness programs, but it has been tailored to meet the needs and demands of employees.The MFA will take place in a group setting with 10-15 participants per cluster. Due to participants' convenience, the delivery mode of each intervention session would be conducted online. At the end of session, they will be provided the task and supplementary materials (e-book, short audio, and video) to be apply after the session.

The modules will be delivered by two trainees. Both trainees have received the certificates from the mindfulness-based strategic awareness training course. Participants in the intervention group will be joining the modules for 5 sessions weekly for 60-minute/session. Details on the modules can be referred in the Supplement material.

Group Type: EXPERIMENTAL

Mindfulness for All

Intervention Type: BEHAVIORAL

Experimental:

The MFA will take place in a group setting with 10-15 participants per cluster. Due to participants' convenience, the delivery mode of each intervention session would be conducted online. At the end of session, they will be provided the task and supplementary materials (e-book, short audio, and video) to be apply after the session. The modules will be delivered by two trainees. Both trainees have received the certificates from the mindfulness-based strategic awareness training course. Participants in the intervention group will be joining the modules for 5 sessions weekly for 60-minute/session. Details on the modules can be referred in the Supplement material.

Wait-list control group

The wait-list control group will receive their training two weeks after interventional group complete their training. There will be a 90-minute online training session aimed at introducing participants to mindfulness in general and encouraging them to practice mindfulness by teaching several techniques. There will be no potential harm occurs among the subjects in the wait-list control group.

Group Type: ACTIVE_COMPARATOR

Mindfulness for All

Intervention Type: BEHAVIORAL

Experimental:

The MFA will take place in a group setting with 10-15 participants per cluster. Due to participants' convenience, the delivery mode of each intervention session would be conducted online. At the end of session, they will be provided the task and supplementary materials (e-book, short audio, and video) to be apply after the session. The modules will be delivered by two trainees. Both trainees have received the certificates from the mindfulness-based strategic awareness training course. Participants in the intervention group will be joining the modules for 5 sessions weekly for 60-minute/session. Details on the modules can be referred in the Supplement material.

Interventions

Mindfulness for All

Experimental:

The MFA will take place in a group setting with 10-15 participants per cluster. Due to participants' convenience, the delivery mode of each intervention session would be conducted online. At the end of session, they will be provided the task and supplementary materials (e-book, short audio, and video) to be apply after the session. The modules will be delivered by two trainees. Both trainees have received the certificates from the mindfulness-based strategic awareness training course. Participants in the intervention group will be joining the modules for 5 sessions weekly for 60-minute/session. Details on the modules can be referred in the Supplement material.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All academic staff aged 28-50 years old
• Able to understand Malay language
• Reported moderate to severe symptom of anxiety with cut-off score of 16,
• Reported mild to severe symptoms of depression with cut-off score of 16
• Presence of LBP during past month with pain intensity should be at least >35mm using Visual analogue scale (VAS).

Exclusion Criteria

• Pregnancy or had planned to become pregnant in the coming months,
• History of trauma or accidents in the spinal region
• Medically diagnosed with congenital anomaly of the spine, rheumatoid arthritis, infections of the spine or discs, ankylosing spondylitis, spondylolisthesis, spondylosis, spinal tumor, systemic lupus erythymatosus, or osteoporosis.
• Had performed either spinal, intra-abdominal or femoral surgery.

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Eva Zamri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva N Zamri, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Central Contacts

Eva N Zamri, PhD

Role: CONTACT

evazamri@usm.my

+60192184647

Other Identifiers

304/CIPPT/6315622

Identifier Type: -

Identifier Source: org_study_id