Lumbar Disc SurgeryNCT06770387
Telenursing and Transitional Care
A study testing mhealth in people with Lumbar Disc Surgery, run by Hasan Kalyoncu University at 4 sites in Turkey (Türkiye).
Trial summary
Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Surgery
- What is being tested?
- mhealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 24 Dec 2024to 30 May 2025
- 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
- Patients who are 18 years of age or older,
- Can speak and understand Turkish,
- Have no hearing, understanding, vision or speech problems,
- Have undergone LDH surgery for the first time,
- Have undergone LDH surgery with the open method,
- Have not been diagnosed with depression or anxiety disorder before surgery and are not taking medication for this purpose,
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- Have a smart mobile phone suitable for taking photos or for those close to them,
- Have not developed serious complications that would delay their discharge from the hospital,
- Volunteer to participate in the study will be included in the study.
Who cannot join
- Patients who wish to withdraw from the study at any stage after voluntarily participating in the study.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Deva Hospital
Gaziantep, 27027
Gaziantep University Şahinbey Research and Application Hospital
Gaziantep, 27027
Medical Point Hospital
Gaziantep, 27027
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
Kahramanmaraş, 46046
About this study
Official title: Telenursing and Transitional Care After Lumbar Disc Herniation Surgery: A New Paradigm for Postoperative Care
Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. The aim of the study is to determine the effects of transitional model-based telenursing and mobile application-based follow-up on fall risk, post-discharge recovery, mobility, anxiety, and complications in patients who underwent lumbar disc surgery.
- Conditions
- Lumbar Disc Surgery
- Being tested
- mhealth
- Keywords
- mHealth, telenursing, transitional care, lumbar disc surgery, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhealthBehavioural
mobile application for postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention, only routin care |
| Intervention Group | Experimental | Telenursing and mHealth intervention Receives: Behavioral: mhealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
developing complications
Measured: From enrollment to the end of treatment at 1 weeks
Rehospitalization
hospitalization in the postoperative period
Measured: From enrollment to the end of treatment at 1 weeks
Readmission
admission to hospital in the postoperative period
Measured: From enrollment to the end of treatment at 1 weeks
Secondary outcomes (3)
Measuring recovery status with the Post-Discharge Surgical Recovery Scale
Postoperative recovery
Measured: From enrollment to the end of treatment at 4 weeks
mobilization
postoperative mobilization
Measured: From enrollment to the end of treatment at 4 weeks
Measurement of anxiety status with the hospital anxiety depression scale
Determination of change in anxiety levels between groups before discharge and one month after discharge
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start24 Dec 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc SurgeryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadiriye Pehlivan, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770387
- Sponsor's protocol ID
- New Paradigma
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telenursing and Transitional Care After Lumbar Disc Herniation Surgery: A New Paradigm for Postoperative Care
- ClinicalTrials.gov ID
- NCT06770387
- Acronym / sponsor ID
- New Paradigma
- Conditions
- Lumbar Disc Surgery
- Keywords
- mHealth, telenursing, transitional care, lumbar disc surgery, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 13 Jan 2025 (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.
Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. The aim of the study is to determine the effects of transitional model-based telenursing and mobile application-based follow-up on fall risk, post-discharge recovery, mobility, anxiety, and complications in patients who underwent lumbar disc surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention, only routin care |
| Intervention Group | Experimental | Behavioral: mhealthTelenursing and mHealth intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are 18 years of age or older,
- Can speak and understand Turkish,
- Have no hearing, understanding, vision or speech problems,
- Have undergone LDH surgery for the first time,
- Have undergone LDH surgery with the open method,
Key exclusion criteria (1 listed)
- Patients who wish to withdraw from the study at any stage after voluntarily participating in the study.
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 |
|---|---|---|
| mhealthmobile application for postoperative period | Behavioural | Intervention Group |
Primary outcome
Complication
Time frame: From enrollment to the end of treatment at 1 weeks
developing complications
Rehospitalization
Time frame: From enrollment to the end of treatment at 1 weeks
hospitalization in the postoperative period
Readmission
Time frame: From enrollment to the end of treatment at 1 weeks
admission to hospital in the postoperative period
3 secondary outcomes
Measuring recovery status with the Post-Discharge Surgical Recovery Scale
Time frame: From enrollment to the end of treatment at 4 weeks
mobilization
Time frame: From enrollment to the end of treatment at 4 weeks
Measurement of anxiety status with the hospital anxiety depression scale
Time frame: From enrollment to the end of treatment at 4 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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhealth in people with Lumbar Disc Surgery, run by Hasan Kalyoncu University at 4 sites 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 9 inclusion and 1 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Complication (time frame: From enrollment to the end of treatment at 1 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.