Chronic PainNCT06698354
Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study
A study testing Virtual Reality-Assisted Hypnotherapy and Standard Physical Therapy in people with Chronic Pain and Low Back Pain, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic low back pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Pain, Low Back Pain, Chronic Low Back Pain (CLBP)
- What is being tested?
- Virtual Reality-Assisted Hypnotherapy and Standard Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 80 years.
- Chronic neck pain lasting for more than 3 month
Who cannot join
- Presence of newly developed neurological deficits.
- Existence of comorbid neurological diseases.
- Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
- Pregnancy.
- Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Beykent University Faculty of Medicine, Physical Therapy Unit
Istanbul
Tugba Sahbaz, Assoc Prof, piskint@gmail.com
About this study
This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic low back pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic low back pain management.
- Conditions
- Chronic Pain, Low Back Pain, Chronic Low Back Pain (CLBP)
- Being tested
- Virtual Reality-Assisted Hypnotherapy, Standard Physical Therapy
- Keywords
- hypnotherapy, virtual reality
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Assisted HypnotherapyDevice
Virtual Reality-Assisted Hypnotherapy utilizes HypnoVR software delivered through VR glasses to provide a relaxing virtual environment. The intervention is integrated into a standard physical therapy program, with participants receiving 20-minute VR-assisted hypnotherapy sessions during each of the 15 supervised physical therapy sessions over a 3-week period. This approach aims to improve pain management, quality of life, and adherence to treatment in patients with chronic low back pain.
Standard Physical TherapyOther
Participants in the control group will undergo a standard physical therapy program focused on the cervical region, consisting of 15 sessions over 3 weeks. Each session will be supervised by physiotherapists in a clinical setting and will include traditional physical therapy techniques such as therapeutic exercises
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group | Experimental | Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. Additionally, during each physical therapy session, participants will receive a 20-minute Virtual Reality (VR)-assisted hypnotherapy session using the HypnoVR software. Receives: Device: Virtual Reality-Assisted Hypnotherapy |
| Standard Treatment Group | Active comparator | Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
The primary outcome is the percentage change in pain intensity, measured using the Visual Analog Scale (VAS). A reduction of ≥30% in the VAS score from baseline is considered clinically significant.
Measured: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.
Secondary outcomes (5)
Change in Functional Status
Functional status will be assessed using the Roland-Morris Disability Index.
Measured: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Change in Quality of Life
Quality of life will be measured using the EQ-5D-5L questionnaire.
Measured: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Reduction in Analgesic Use
The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded.
Measured: Baseline and weekly throughout the 3-month follow-up period.
Change in Anxiety and Depression Levels
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Measured: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Reduction in Healthcare Utilization
Healthcare utilization, including the number of clinic visits (Family Medicine, Physical Therapy, Orthopedics) and cervical imaging (X-ray, MRI), will be recorded for the 3 months prior to and after the intervention.
Measured: Assessed retrospectively at baseline and at the 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start2 Dec 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TUĞBA ŞAHBAZ, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698354
- Sponsor's protocol ID
- E-66291034-202.3.02-6546
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Menekseoglu AK, Asik HK, Sahbaz T, Is EE. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial. Ir J Med Sci. 2026 Feb;195(1):177-185. doi: 10.1007/s11845-025-04158-1. Epub 2025 Nov 10.
PubMed 41212507
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT06698354
- Acronym / sponsor ID
- E-66291034-202.3.02-6546
- Conditions
- Chronic Pain, Low Back Pain, Chronic Low Back Pain (CLBP)
- Keywords
- hypnotherapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Nov 2024 (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 randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic low back pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic low back pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group | Experimental | Device: Virtual Reality-Assisted HypnotherapyParticipants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. Additionally, during each physical therapy session, participants will receive a 20-minute Virtual Reality (VR)-assisted hypnotherapy session using the HypnoVR software. |
| Standard Treatment Group | Active comparator | Other: Standard Physical TherapyParticipants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 50 and 80 years.
- Chronic neck pain lasting for more than 3 month
Key exclusion criteria (5 listed)
- Presence of newly developed neurological deficits.
- Existence of comorbid neurological diseases.
- Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
- Pregnancy.
- Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).
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 |
|---|---|---|
| Virtual Reality-Assisted HypnotherapyVirtual Reality-Assisted Hypnotherapy utilizes HypnoVR software delivered through VR glasses to provide a relaxing virtual environment. The intervention is integrated into a standard physical therapy program, with participants receiving 20-minute VR-assisted hypnotherapy sessions during each of the 15 supervised physical therapy sessions over a 3-week period. This approach aims to improve pain management, quality of life, and adherence to treatment in patients with chronic low back pain. | Device | Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group |
| Standard Physical TherapyParticipants in the control group will undergo a standard physical therapy program focused on the cervical region, consisting of 15 sessions over 3 weeks. Each session will be supervised by physiotherapists in a clinical setting and will include traditional physical therapy techniques such as therapeutic exercises | Other | Standard Treatment Group |
Primary outcome
Change in Pain Intensity
Time frame: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.
The primary outcome is the percentage change in pain intensity, measured using the Visual Analog Scale (VAS). A reduction of ≥30% in the VAS score from baseline is considered clinically significant.
5 secondary outcomes
Change in Functional Status
Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Change in Quality of Life
Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Reduction in Analgesic Use
Time frame: Baseline and weekly throughout the 3-month follow-up period.
Change in Anxiety and Depression Levels
Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Reduction in Healthcare Utilization
Time frame: Assessed retrospectively at baseline and at the 3-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 41212507Menekseoglu AK, Asik HK, Sahbaz T, Is EE. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial. Ir J Med Sci. 2026 Feb;195(1):177-185. doi: 10.1007/s11845-025-04158-1. Epub 2025 Nov 10.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Assisted Hypnotherapy and Standard Physical Therapy in people with Chronic Pain and Low Back Pain, run by University of Beykent 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Sahbaz, Associate Professor (+90444 1997 ext. 6021, piskint@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.). 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 NCT06698354, which also lists 1 linked publication.
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 21 Nov 2024.