Nursing CareNCT03792230
Comparison Of The Effects Of Different Body Mechanics Education
A study testing Video and Brochure in people with Nursing Care and Patient Education, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Care, Patient Education
- What is being tested?
- Video and Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2017to 1 Aug 2017
- 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 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nursing Care, Patient Education
- Being tested
- Video, Brochure
- Keywords
- Lumbar disc hernia surgery, Body mechanics, Patient education, Quality of life, Disability, Pain, Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Video group receive body mechanic education via CD material,
BrochureBehavioural
Brochure group receive body mechanic education via written material (brochure)
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | This group received educatıon via video material Receives: Behavioral: Video |
| Brochure | Experimental | This group received education via written material (brochure) Receives: Behavioral: Brochure |
| Control | No intervention | This group received standart clinical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: Change from pain at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start15 Jan 2017
- Primary completion15 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies 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
- prospective randomised controlled study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgu Bakcek, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Özgü Bakçek, Principal investigator, Health Science University Gulhane Faculty of Nursing, ANKARA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792230
- Sponsor's protocol ID
- ozgubakcek
- Status last verified
- Dec 2018
- First submitted
- 30 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study publish, we actually shared all procedurs.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Different Body Mechanics Education Methods On Pain, Disability And Quality Of Life: Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03792230
- Acronym / sponsor ID
- ozgubakcek
- Conditions
- Nursing Care, Patient Education
- Keywords
- Lumbar disc hernia surgery, Body mechanics, Patient education, Quality of life, Disability, Pain, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 3 Jan 2019 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- prospective randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: VideoThis group received educatıon via video material |
| Brochure | Experimental | Behavioral: BrochureThis group received education via written material (brochure) |
| Control | No intervention | –This group received standart clinical education |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| VideoVideo group receive body mechanic education via CD material, | Behavioural | Video |
| BrochureBrochure group receive body mechanic education via written material (brochure) | Behavioural | Brochure |
Primary outcome
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
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)
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.
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 3 Jan 2019.
- Individual participant dataSharing planned: Yes. After the study publish, we actually shared all procedurs.
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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.
Özgü Bakçek principal investigator
Health Science University Gulhane Faculty of Nursing, ANKARA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Brochure in people with Nursing Care and Patient Education, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 5 inclusion and 3 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 3 Jan 2019. 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?
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?
Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) (time frame: Change from quality of life at 6 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 3 Jan 2019.