- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06190873
The Effect of Telephone Education on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery.
December 19, 2023 updated by: Nilgün Temel, Çanakkale Onsekiz Mart University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nilgun Temel
- Phone Number: 05466520892
- Email: nilgun.yavas91@gmail.com
Study Locations
-
-
-
Çanakkale, Turkey, 17100
- Recruiting
- Çanakkale Mehmet Akif Ersoy Devlet Hastenesi
-
Contact:
- Nilgun Temel
- Phone Number: 05466520892
- Email: nilgun.yavas91@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group to be trained over the phone
This group will be trained by phone for 6 weeks after discharge.
|
Telephone training will be provided for post-discharge rehabilitation
Other Names:
|
No Intervention: Group without telephone training
This group will be given training during their stay in the hospital.
There will be no training over the phone after discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life scale
Time Frame: six week
|
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.
|
six week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
December 11, 2023
First Submitted That Met QC Criteria
December 19, 2023
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMÜ- SBF-NT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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