Comparison Of The Effects Of Different Body Mechanics Education

Patient Education Clinical Trial

Official title:

Comparison Of The Effects Of Different Body Mechanics Education Methods On Pain, Disability And Quality Of Life: Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792230
• Other study ID #: ozgubakcek
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: December 2018
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 1, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Nursing Care
• Patient Education

Intervention

Behavioral:
• Video
Video group receive body mechanic education via CD material,
• Brochure
Brochure group receive body mechanic education via written material (brochure)

Locations

Country	Name	City	State
Turkey	Özgü Bakçek	Ankara	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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