Spine DiseaseNCT06190873
The Effect of Telephone Education on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery.
A study testing post-discharge rehabilitation training in people with Spine Disease and Spinal Deformity, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to quantify the fear of movement and quality of life of telephone education on lumbar disc herniation surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Disease, Spinal Deformity
- What is being tested?
- post-discharge rehabilitation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being over 18 years old
- knowing how to read and write Turkish
- No hearing or speech impairment
- Having lumbar disc herniation surgery for the first time
- having a personal cell phone
- being discharged 5 days after surgery
Who cannot join
- being under 18 years old
- being illiterate
- having a hearing and speech disability
- not having a personal cell phone
- staying in the hospital for more than 5 days after surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çanakkale Mehmet Akif Ersoy Devlet Hastenesi
Çanakkale, 17100
Nilgun Temel, 05466520892, nilgun.yavas91@gmail.com
About this study
Official title: Effect of Telephone Training on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery: Randomized Controlled Study.
The aim is to quantify the fear of movement and quality of life of telephone education on lumbar disc herniation surgery.
Read the detailed description
In the randomized controlled study, patients will be randomized into two categories: experimental and control groups. The experimental group will receive intervention via online information for 6 weeks after discharge. The control group will not be given online training other than standard nursing care. At the end of 6 weeks, the difference between fear of movement and quality of life between the two groups will be examined.
- Conditions
- Spine Disease, Spinal Deformity
- Being tested
- post-discharge rehabilitation training
- Keywords
- life quality, telehealty, tele nursing, kinezyofobi
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-discharge rehabilitation trainingBehavioural
Also called nursingcare, nursing education
Telephone training will be provided for post-discharge rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| group to be trained over the phone | Experimental | This group will be trained by phone for 6 weeks after discharge. Receives: Behavioral: post-discharge rehabilitation training |
| Group without telephone training | No intervention | This group will be given training during their stay in the hospital. There will be no training over the phone after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
movement fear scale
In the measurement to be made with a four-point Likert type scale, 17 is the lowest score and 68 is the highest score. The higher the score the patient receives, the greater the fear of movement.
Measured: six week
Secondary outcomes (1)
quality of life scale
The score obtained from the scale varies between 0 and 100. As the score obtained from the scale increases, the patient's quality of life increases.
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies 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
- There will be two groups, one is the control group and the other is the intervention group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Temel, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190873
- Sponsor's protocol ID
- COMÜ- SBF-NT-01
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telephone Training on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06190873
- Acronym / sponsor ID
- COMÜ- SBF-NT-01
- Conditions
- Spine Disease, Spinal Deformity
- Keywords
- life quality, telehealty, tele nursing, kinezyofobi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Jan 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.
The aim is to quantify the fear of movement and quality of life of telephone education on lumbar disc herniation surgery.
Detailed description
In the randomized controlled study, patients will be randomized into two categories: experimental and control groups. The experimental group will receive intervention via online information for 6 weeks after discharge. The control group will not be given online training other than standard nursing care. At the end of 6 weeks, the difference between fear of movement and quality of life between the two groups will be examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups, one is the control group and the other is the intervention group.
| Arm | Type | Receives |
|---|---|---|
| group to be trained over the phone | Experimental | Behavioral: post-discharge rehabilitation trainingThis group will be trained by phone for 6 weeks after discharge. |
| Group without telephone training | No intervention | –This group will be given training during their stay in the hospital. There will be no training over the phone after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being over 18 years old
- knowing how to read and write Turkish
- No hearing or speech impairment
- Having lumbar disc herniation surgery for the first time
- having a personal cell phone
Key exclusion criteria (5 listed)
- being under 18 years old
- being illiterate
- having a hearing and speech disability
- not having a personal cell phone
- staying in the hospital for more than 5 days after surgery
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 |
|---|---|---|
| post-discharge rehabilitation trainingAlso: nursingcare, nursing educationTelephone training will be provided for post-discharge rehabilitation | Behavioural | group to be trained over the phone |
Primary outcome
movement fear scale
Time frame: six week
In the measurement to be made with a four-point Likert type scale, 17 is the lowest score and 68 is the highest score. The higher the score the patient receives, the greater the fear of movement.
1 secondary outcome
quality of life scale
Time frame: six week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-discharge rehabilitation training in people with Spine Disease and Spinal Deformity, run by Çanakkale Onsekiz Mart 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 6 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilgun Temel (05466520892, nilgun.yavas91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
movement fear scale (time frame: six week). 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 5 Jan 2024.