Comparison Of The Effects Of Different Body Mechanics Education
1 other identifier
interventional
3
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 30, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedJanuary 3, 2019
December 1, 2018
6 months
December 30, 2018
December 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)
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)
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)
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
Study Arms (3)
Video
EXPERIMENTALThis group received educatıon via video material
Brochure
EXPERIMENTALThis group received education via written material (brochure)
Control
NO INTERVENTIONThis group received standart clinical education
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Özgü Bakçek
Ankara, Eyalet/Yerleşke, 06010, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Özgü Bakçek
Health Science University Gulhane Faculty of Nursing, ANKARA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Because of only one investigator, there is no blinding
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science
Study Record Dates
First Submitted
December 30, 2018
First Posted
January 3, 2019
Study Start
January 15, 2017
Primary Completion
July 15, 2017
Study Completion
August 1, 2017
Last Updated
January 3, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data collection have been completed
After the study publish, we actually shared all procedurs.