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CompletedNCT03792230Updated Jan 3, 2019

Comparison Of The Effects Of Different Body Mechanics Education

An interventional study of Video and Brochure in Nursing Care and Patient Education, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed at 1 site in Turkey. Open to participants aged 18 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-03.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 78 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Nursing Care
  • Patient Education

Keywords

  • Lumbar disc hernia surgery
  • Body mechanics
  • Patient education
  • Quality of life
  • Disability
  • Pain
  • Nursing
03

In context

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Video

    This group received educatıon via video material

    Behavioral: Video

  • Experimental
    Brochure

    This group received education via written material (brochure)

    Behavioral: Brochure

  • No intervention
    Control

    This group received standart clinical education

Interventions

  • BehavioralVideo

    Video group receive body mechanic education via CD material,

  • BehavioralBrochure

    Brochure group receive body mechanic education via written material (brochure)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from quality of life at 6 weeks

  2. 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)

    Time frame: Change from disability at 6 weeks

  3. 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.

    Time frame: Change from pain at 6 weeks

07

Study locations

1 site
  • Özgü Bakçek
    Ankara, Eyalet/Yerleşke 06010, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — After the study publish, we actually shared all procedurs.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03792230
Lead sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party
Ozgu Bakcek (Master of Science, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted
Jan 3, 2019
Start date
Jan 15, 2017
Primary completion
Jul 15, 2017
Completion
Aug 1, 2017
Last update
Jan 3, 2019

Study contacts

Özgü Bakçek
principal investigator · Health Science University Gulhane Faculty of Nursing, ANKARA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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