NCT03792230

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 30, 2018

Last Update Submit

December 30, 2018

Conditions

Keywords

Lumbar disc hernia surgeryBody mechanicsPatient educationQuality of lifeDisabilityPainNursing

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

EXPERIMENTAL

This group received educatıon via video material

Behavioral: Video

Brochure

EXPERIMENTAL

This group received education via written material (brochure)

Behavioral: Brochure

Control

NO INTERVENTION

This group received standart clinical education

Interventions

VideoBEHAVIORAL

Video group receive body mechanic education via CD material,

Video
BrochureBEHAVIORAL

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

Brochure

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Pain

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Özgü Bakçek

    Health Science University Gulhane Faculty of Nursing, ANKARA

    PRINCIPAL INVESTIGATOR

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
Model Details: prospective randomised controlled study
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

After the study publish, we actually shared all procedurs.

Shared Documents
STUDY PROTOCOL
Time Frame
Data collection have been completed

Locations