NCT07683884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

February 3, 2026

Last Update Submit

June 28, 2026

Conditions

Keywords

MBSR ThrepiesLumbar disc herniationthoughtspainnursing

Outcome Measures

Primary Outcomes (1)

  • Mindful Attention Awareness Scale for mindfulness

    Mindfulness-based psychoeducation has an effect on mindfulness pain beliefs in the intervention group.

    eight weeks

Secondary Outcomes (1)

  • Automatic Thoughts Questionnaire for automatic thoughts

    eight weeks

Other Outcomes (1)

  • Pain Beliefs Questionnaire for pain beliefs

    eight weeks

Study Arms (2)

mindfulness-based psychoeducation

EXPERIMENTAL

in which mindfulness-based psychoeducation was applied.

Device: Experimental Group

Control group

ACTIVE COMPARATOR

in which patients did not receive any treatment and received routine postoperative care in the clinic.

Device: control group

Interventions

In 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:

mindfulness-based psychoeducation

in which patients did not receive any treatment and received routine postoperative care in the clinic.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being hospitalized with a diagnosis of lumbar disc herniation,
  • Not taking any anxiolytic medication,
  • Being willing to participate in the study.

You may not qualify if:

  • Attending fewer than two sessions,
  • Having psychotic disorders or substance dependence,
  • Having insufficient cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University

Giresun, Piraziz, 28340, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 35779457BACKGROUND
  • Fritz 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.

    PMID: 36069630BACKGROUND
  • Zgierska 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.

    PMID: 40193079BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2026

First Posted

July 6, 2026

Study Start

January 1, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

We plan to publish the research findings in a scientific journal. We can share our data if a publishing house requests it.

Locations