- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03792230
Comparison Of The Effects Of Different Body Mechanics Education
December 30, 2018 updated by: Ozgu Bakcek, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Comparison Of The Effects Of Different Body Mechanics Education Methods On Pain, Disability And Quality Of Life: Randomised Controlled Study
The study evaluated the comparison of the different patient education methods.
The study involved two stages of data collection: one during the preoperative period, the other during the sixth postoperative week.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Before commencing the study, we informed participants who met the inclusion criteria about the scope of the study and obtained their written and oral consent.
Participants in each group completed the data collection form regarding patients' characteristics, the SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36.
A day before LDH (Lumbar Disc Hernia) surgery, participants in the control group received standard clinical education, whereas ones in the intervention groups received either video- or brochure-based education.
Participants in the brochure group learned about the proper use of body mechanics from the "Body Mechanics Educational Brochure for LDH Patients" and demonstrations performed by primary investigator after which we answered any questions that participants asked.
Brochure-based education took nearly 15 min, and participants could keep the brochures after the education programme ended.
By contrast, participants in the video group learned about proper use of body mechanics from the "Body Mechanics Educational Video for LDH Patients" presented on a laptop, after which we also answered any questions that participants asked.
Video-based education took nearly 15 min, and we provided CD-ROM with the video to the participants.
Unlike participants in the intervention groups, ones in the control group did not receive structured education.
Clinical nurses orally informed them about points to consider while performing activities such as standing, rising from bed and lifting.
Final data collection took place in the sixth postoperative week, following the statement of the American Association of Neuroscience Nurses that pain and disability begin to decrease and that quality of life begins to increase 4-6 weeks after thoracolumbar surgery (Starkweather et al., 2013).
During the postoperative period, participants in all groups completed the SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36.
Participants in the brochure and video groups also completed the survey addressing their satisfaction with the educational materials, whereas ones in the control group completed the survey addressing their satisfaction with the clinical education that they received.
We collected data face-to-face with participants, which took approximately 20 min.
Participants who lived outside Ankara completed the respective survey via telephone interviews, which took approximately 30 min.
Study Type
Interventional
Enrollment (Actual)
3
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 Locations
-
-
Eyalet/Yerleşke
-
Ankara, Eyalet/Yerleşke, Turkey, 06010
- Özgü Bakçek
-
-
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
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients hospitalised in preparation to receive LDH surgery and who volunteered to participate
- Older than 18 years
- Could read and write in Turkish
- Scored between 1 and 3 in the classification systems of the American Society of Anesthesiologists were preparing for their first LDH surgical operation
- Could use CD-based educational materials
Exclusion Criteria:
- Patients hospitalised in preparation to receive LDH surgery and who unvolunteered to participate
- All potential participants who had previously undergone LDH surgery
- Could not use CD-based educational materials or had mental disorders liable to prevent communication
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video
This group received educatıon via video material
|
Video group receive body mechanic education via CD material,
|
Experimental: Brochure
This group received education via written material (brochure)
|
Brochure group receive body mechanic education via written material (brochure)
|
No Intervention: Control
This group received standart clinical education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)
Time Frame: Change from quality of life at 6 weeks
|
Of the instrument's eight subscales and 36 items, we used the Physical Functioning (i.e. 10 items) and Bodily Pain (i.e. 2 items) subscales.
Final scores for each subscale are calculated by dividing the score obtained by the number of items on the subscale.
Final scores on the subscales range from 0 to 100; higher scores indicate higher quality of life
|
Change from quality of life at 6 weeks
|
Oswestry Disability Index (ODI)
Time Frame: Change from disability at 6 weeks
|
The ODI has 10 questions addressing the intensity of pain, personal care, walking, sitting, standing and lifting behaviours, sex life, social life, sleep routines and travelling tendencies.
Patients respond to each question on a 6-point Likert scale; for each question, scores range from 0 (i.e.
no disability) to 5 (i.e.
most severe disability).
By contrast, total scores range between 0 and 50 and are interpreted to indicate minimal disability (0-4 points), moderate disability (5-14 points), severe disability (15-24 points), crippled (25-34 points) or bed-bound (35-50 points)
|
Change from disability at 6 weeks
|
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Change from pain at 6 weeks
|
This questionnaire evaluated the reliability and validity of the Turkish version of the instrument.
The scale evaluates acute pain and consists of sensory, affective and intensity subscales; higher scores indicate a higher intensity of pain.
|
Change from pain at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Özgü Bakçek, Health Science University Gulhane Faculty of Nursing, ANKARA
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)
January 15, 2017
Primary Completion (Actual)
July 15, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
December 30, 2018
First Submitted That Met QC Criteria
December 30, 2018
First Posted (Actual)
January 3, 2019
Study Record Updates
Last Update Posted (Actual)
January 3, 2019
Last Update Submitted That Met QC Criteria
December 30, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ozgubakcek
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After the study publish, we actually shared all procedurs.
IPD Sharing Time Frame
Data collection have been completed
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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