Lumbar Disc HerniationMBPENCT07683884
Mindfulness-based Psychoeducation in Patients With Lumbar Disc Herniation
A study testing Experimental Group in people with Lumbar Disc Herniation and Mindfulness Meditation, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of mindfulness-based psychoeducation on mindfulness, automatic thoughts, and pain beliefs in patients with lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Mindfulness Meditation
- What is being tested?
- Experimental Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being hospitalized with a diagnosis of lumbar disc herniation,
- Not taking any anxiolytic medication,
- Being willing to participate in the study.
Who cannot join
- Attending fewer than two sessions,
- Having psychotic disorders or substance dependence,
- Having insufficient cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-based Psychoeducation on Mindfulness, Automatic Thoughts, and Pain Beliefs in Patients With Lumbar Disc Herniation
This study aimed to investigate the effect of mindfulness-based psychoeducation on mindfulness, automatic thoughts, and pain beliefs in patients with lumbar disc herniation.
Read the detailed description
This study aimed to investigate the effect of mindfulness-based psychoeducation on mindfulness, automatic thoughts, and pain beliefs in patients with lumbar disc herniation. The intervention group will undergo an eight-week program. Scales will be administered before and after the program. The control group will receive no intervention.
- Conditions
- Lumbar Disc Herniation, Mindfulness Meditation
- Being tested
- Experimental Group, control group
- Keywords
- MBSR Threpies, Lumbar disc herniation, thoughts, pain, nursing
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupDevice
In total, each patient attended eight sessions. The sessions of program were:
- Session: Introduction and group awareness, overview of the MBPE program, communication skills, body awareness, and mindful engagement in daily activities.
- and 3. Sessions: Exploration of the concept of mindfulness, information about lumbar disc herniation and pain mechanisms, identifying the changes pain brings to patients' lives.
- Session: Emotions, thoughts, and behaviors model; understanding automatic pilot responses.
- Session: Breath awareness practices. 6. Session:
control groupDevice
in which patients did not receive any treatment and received routine postoperative care in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based psychoeducation | Experimental | in which mindfulness-based psychoeducation was applied. Receives: Device: Experimental Group |
| Control group | Active comparator | in which patients did not receive any treatment and received routine postoperative care in the clinic. Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Attention Awareness Scale for mindfulness
Mindfulness-based psychoeducation has an effect on mindfulness pain beliefs in the intervention group.
Measured: eight weeks
Secondary outcomes (1)
Automatic Thoughts Questionnaire for automatic thoughts
Mindfulness-based psychoeducation has an effect on automatic thoughts in the intervention group.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jan 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sessions of program were: 1. Session: Introduction and group awareness, overview of the MBPE program, communication skills, body awareness, and mindful engagement in daily activities. 2. and 3. Sessions: Exploration of the concept of mindfulness, information about lumbar disc herniation and pain mechanisms, identifying the changes pain brings to patients' lives. 4\. Session: Emotions, thoughts, and behaviors model; understanding automatic pilot responses. 5\. Session: Breath awareness practices. 6. Session: Body scan meditation. 7. Session: Compassionate acceptance meditation. 8. Session: Developing new perspectives, valuing "moments" in daily life, mindfulness toolkit, and evaluation/closure of the group process.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Collaborators
- Aksaray University
- Responsible party
- Principal investigator, Emel Bahadır Yılmaz, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683884
- Sponsor's protocol ID
- SBFEBY
- Acronym
- MBPE
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to publish the research findings in a scientific journal. We can share our data if a publishing house requests it.
Publications
Soundararajan K, Prem V, Kishen TJ. The effectiveness of mindfulness-based stress reduction intervention on physical function in individuals with chronic low back pain: Systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2022 Nov;49:101623. doi: 10.1016/j.ctcp.2022.101623. Epub 2022 Jun 23.
PubMed 35779457Fritz JM, Rhon DI, Garland EL, Hanley AW, Greenlee T, Fino N, Martin B, Highland KB, Greene T. The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Postsurgical Rehabilitation After Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program. Pain Med. 2023 Aug 4;24(Suppl 1):S115-S125. doi: 10.1093/pm/pnac138.
PubMed 36069630Zgierska AE, Edwards RR, Barrett B, Burzinski CA, Jamison RN, Nakamura Y, Henningfield MF, Tuan WJ, Shen C, Sehgal N, Lennon RP, Dong H, Chinchilli VM, Liu Y, Turnquist A, Schiefelbein AR, Jacobs EA, Veasley C, Cowan P, Garland EL. Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253204. doi: 10.1001/jamanetworkopen.2025.3204.
PubMed 40193079
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-based Psychoeducation on Mindfulness, Automatic Thoughts, and Pain Beliefs in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07683884
- Acronym / sponsor ID
- MBPE / SBFEBY
- Conditions
- Lumbar Disc Herniation, Mindfulness Meditation
- Keywords
- MBSR Threpies, Lumbar disc herniation, thoughts, pain, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Collaborators
- Aksaray University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate the effect of mindfulness-based psychoeducation on mindfulness, automatic thoughts, and pain beliefs in patients with lumbar disc herniation.
Detailed description
This study aimed to investigate the effect of mindfulness-based psychoeducation on mindfulness, automatic thoughts, and pain beliefs in patients with lumbar disc herniation. The intervention group will undergo an eight-week program. Scales will be administered before and after the program. The control group will receive no intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sessions of program were: 1. Session: Introduction and group awareness, overview of the MBPE program, communication skills, body awareness, and mindful engagement in daily activities. 2. and 3. Sessions: Exploration of the concept of mindfulness, information about lumbar disc herniation and pain mechanisms, identifying the changes pain brings to patients' lives. 4. Session: Emotions, thoughts, and behaviors model; understanding automatic pilot responses. 5. Session: Breath awareness practices. 6. Session: Body scan meditation. 7. Session: Compassionate acceptance meditation. 8. Session: Developing new perspectives, valuing "moments" in daily life, mindfulness toolkit, and evaluation/closure of the group process.
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based psychoeducation | Experimental | Device: Experimental Groupin which mindfulness-based psychoeducation was applied. |
| Control group | Active comparator | Device: control groupin which patients did not receive any treatment and received routine postoperative care in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being hospitalized with a diagnosis of lumbar disc herniation,
- Not taking any anxiolytic medication,
- Being willing to participate in the study.
Key exclusion criteria (3 listed)
- Attending fewer than two sessions,
- Having psychotic disorders or substance dependence,
- Having insufficient cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupIn total, each patient attended eight sessions. The sessions of program were: 1. Session: Introduction and group awareness, overview of the MBPE program, communication skills, body awareness, and mindful engagement in daily activities. 2. and 3. Sessions: Exploration of the concept of mindfulness, information about lumbar disc herniation and pain mechanisms, identifying the changes pain brings to patients' lives. 4. Session: Emotions, thoughts, and behaviors model; understanding automatic pilot responses. 5. Session: Breath awareness practices. 6. Session: | Device | mindfulness-based psychoeducation |
| control groupin which patients did not receive any treatment and received routine postoperative care in the clinic. | Device | Control group |
Primary outcome
Mindful Attention Awareness Scale for mindfulness
Time frame: eight weeks
Mindfulness-based psychoeducation has an effect on mindfulness pain beliefs in the intervention group.
1 secondary outcome
Automatic Thoughts Questionnaire for automatic thoughts
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 35779457Soundararajan K, Prem V, Kishen TJ. The effectiveness of mindfulness-based stress reduction intervention on physical function in individuals with chronic low back pain: Systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2022 Nov;49:101623. doi: 10.1016/j.ctcp.2022.101623. Epub 2022 Jun 23.
- Background: PubMed 36069630Fritz JM, Rhon DI, Garland EL, Hanley AW, Greenlee T, Fino N, Martin B, Highland KB, Greene T. The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Postsurgical Rehabilitation After Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program. Pain Med. 2023 Aug 4;24(Suppl 1):S115-S125. doi: 10.1093/pm/pnac138.
- Background: PubMed 40193079Zgierska AE, Edwards RR, Barrett B, Burzinski CA, Jamison RN, Nakamura Y, Henningfield MF, Tuan WJ, Shen C, Sehgal N, Lennon RP, Dong H, Chinchilli VM, Liu Y, Turnquist A, Schiefelbein AR, Jacobs EA, Veasley C, Cowan P, Garland EL. Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253204. doi: 10.1001/jamanetworkopen.2025.3204.
- Individual participant dataSharing planned: No. We plan to publish the research findings in a scientific journal. We can share our data if a publishing house requests it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Lumbar Disc Herniation and Mindfulness Meditation, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful Attention Awareness Scale for mindfulness (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07683884, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.