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Not yet recruitingNCT07916597Updated Nov 4, 2026

Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy

An interventional study of Patient Education and ChatGPT in Chronic Low Back Pain (CLBP), sponsored by Amasya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Amasya University · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The goal of this study is to learn if ChatGPT-generated answers can improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain compared to supervised pain education. The main questions it aims to answer are: Does ChatGPT improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain? Is ChatGPT as effective as supervised pain education? Participants will: complete baseline questionnaires online, attend a single 30-60 minute online session (randomly assigned to either a supervised pain education presentation or asking frequently questions about low back pain to ChatGPT)

Read the detailed description

This study aims to investigate the effects of responses provided by ChatGPT to frequently asked questions about low back pain on pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain, and to compare them with supervised patient education.

Designed as a randomized controlled trial, this research will be conducted with female participants aged 18-65 with a history of low back pain lasting longer than 3 months will be included. Eligible volunteers will be randomly allocated to either the supervised education group or the ChatGPT group. A single 30-minute session will be conducted with participants in both groups. Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire, catastrophizing levels using the Pain Catastrophizing Scale, and self-efficacy levels using the Pain Self-Efficacy Questionnaire. Assessments will be administered twice: immediately before and immediately after the session.

Within the scope of this study, the impact of information obtained from ChatGPT-one of today's widely used and easily accessible AI chatbots-on chronic low back pain, will be revealed. Additionally, comparing these effects with those of supervised pain education may provide a significant contribution to health literacy regarding low back pain.

02

Conditions studied

  • Chronic Low Back Pain (CLBP)

Keywords

  • patient education
  • chronic low back pain
  • artificial intelligence
  • ChatGPT
  • pain management
03

In context

Lead sponsor

Amasya University is the lead sponsor of 81 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • To be between 30 and 60 years old
  • To have pain lasting longer than 3 months
  • To have pain intensity greater than 4 out of 10
  • Ability to communicate effectively and understand the study procedures
  • Ability to conduct video calls via Microsoft Teams and complete questionnaires via Google Forms.
  • To be volunteer to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Having previously received pain neuroscience/education or having asked questions regarding pain to ChatGPT or any other chatbots
  • Being pregnant
  • Diagnosis of endocrinological, psychiatric, urogenital, neurological, dermatological, cardiorespiratory, or musculoskeletal diseases, and/or sleep disorders that could interfere with the study outcomes
  • Currently undergoing other treatments for low back pain (e.g., physical therapy, acupuncture).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Patient Education Group

    Other: Patient Education

  • Active comparator
    ChatGPT Group

    Other: ChatGPT

Interventions

  • OtherPatient Education

    Responses to frequently asked questions about low back pain will be developed within the framework of Pain Neuroscience Education, based on Butler and Moseley's (2003) book "Explain Pain" and current low back pain management guidelines. The prepared responses will be compiled into a PowerPoint presentation and delivered by one of the researchers via screen sharing on Microsoft Teams. The presentation is planned to last approximately 30-60 minutes. All participants in this group will attend the presentation conducted by the same researcher. Participants will not be allowed to ask any additional questions during the session.

  • OtherChatGPT

    Frequently asked questions about low back pain found in the literature will be sent to participants via email. During screen sharing on Microsoft Teams, participants will be asked to submit these questions one by one to an AI chatbot and carefully read the responses. The same researcher will accompany the participants while they ask all the questions to the AI tool. This process is planned to take approximately 30-60 minutes. Participants will not be allowed to ask any additional questions during the session. However, once all evaluations are completed, a PDF version of the presentation prepared by the researchers will also be shared with participants in this group.

06

What researchers measure

Primary outcomes

  1. Pain Beliefs Questionnaire

    Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.

    Time frame: baseline

  2. Pain Catastrophizing Scale

    Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.

    Time frame: baseline

  3. Pain Self-Efficacy Questionnaire

    Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.

    Time frame: baseline

  4. Pain Beliefs Questionnaire

    Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.

    Time frame: immediately after intervention

  5. Pain Catastrophizing Scale

    Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.

    Time frame: immediately after intervention

  6. Pain Self-Efficacy Questionnaire

    Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.

    Time frame: immediately after intervention

07

Study locations

1 site
  • Amasya University
    Amasya, Amasya 05100, Turkey (Türkiye)
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08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jan 2028, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2026
First posted
Nov 4, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Jan 1, 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07916597
Lead sponsor
Amasya University
Responsible party
Aybike Senel (Assistant Professor, Amasya University) — Principal investigator
First posted
Nov 4, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Aybike Şenel, Assistant Professor
Contact
aybikesenel@hotmail.com
0(358)2115005 ext. 4753

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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