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Effect of Feedback Health Education on Postoperative Rehabilitation of Patients With Lumbar Disc Herniation

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Feedback-based health education
Routine health education
Sponsored by
Tianjin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Disc Herniation focused on measuring Feedback method, Health education, Functional exercise

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of lumbar disc herniation Disease
  • Must be able to Cooperate with research

Exclusion Criteria:

  • Lumbar malignant tumors, lumbar tuberculosis and osteoporosis
  • People with mental system diseases.

Sites / Locations

  • Jiangsu College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Feedback-based health education health education and Routine health education

Routine health education

Arm Description

Feedback-based health education:(1) Implementation of the feedback method includes information transmission, patient feedback, clarification and correction, and confirmation of understanding.① One day before surgery: Health education team members provided bedside one-on-one education for patients, 15-20 min per session, twice a day. ② One week after surgery: One-on-one education on rehabilitation exercise was conducted for the patients by the health education team members, 15-20 min per session, twice a day. ③ Two to four weeks after surgery: The health education group members guided the patients through functional rehabilitation exercises via WeChat. Each intervention lasted 20-30 min. The patients interacted once through WeChatB1, and their questions were answered at any time. ④ Five to 12 weeks after surgery: The health education group members guided patients through the functional rehabilitation exercises via WeChat.

Routine health education: Routine health education was given to the patients, and the content of health education was the same as that of the experimental group, including the introduction of the disease, clinical manifestations, significance of examination, therapeutic principles of operative methods, psychological nursing, and postoperative rehabilitation exercise, etc. To verify the effect of health education by feedback method.

Outcomes

Primary Outcome Measures

General data
The content includes general demographic and sociological data such as gender, age and education level, as well as basic information of diseases.
LDH knowledge questionnaire
LDH knowledge questionnaire was prepared by Shi Yixin, with a total of 12 items. The questionnaire was scored by Likert 5, The minimum value is 1 point and the full score being 60 points. The higher the score, the better the patient's knowledge mastery. The content validity of knowledge questionnaire was 0.96 and Cronbach's α coefficient was 0.80.
General Self-Efficacy Scale
In this study, Wang Caikang translated Chinese version of scale general self-efficacy scale consists of 10 entries, beliefs about individual when facing difficulties or problems, adopt Likert level 4 score, each item from "completely incorrect" to "completely correct" respectively in 1 ~ 4 points, The minimum value is 1 point and the maximum value is 40 points, the higher the score shows that the higher the self-efficacy of the patients. The content validity of the scale was 0.87 and Cronbach's α coefficient was 0.83.
Questionnaire on the compliance behaviour of LDH patients
The questionnaire on compliance behavior of LDH patients was prepared by Shi Yixin, a researcher. The contents of the questionnaire included functional exercise, activities, diet, daily living, review, etc.The questionnaire adopts Likert 5 score, The minimum value is 1 point and the maximum value is 90 points. The higher the score, the better the compliance behavior of patients. The content validity of the questionnaire is 0.98, and Cronbach's α coefficient is 0.84.
Oswestry disability index (ODI) scale
This scale is widely used in China and internationally, and in the field of spinal medicine, it is recognized as the gold standard for evaluating curative effects and function . The scale was compiled in 1980 by Fairbank and colleagues and has been revised since ; it was first used in China after it was adapted by Zheng Guangxin . The scale is used to evaluate the efficacy of surgical treatment and is an important reference index in patients with lumbar disease.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2021
Last Updated
May 8, 2021
Sponsor
Tianjin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04885140
Brief Title
Effect of Feedback Health Education on Postoperative Rehabilitation of Patients With Lumbar Disc Herniation
Official Title
Effect of Feedback Health Education on Postoperative Rehabilitation of Patients With Lumbar Disc Herniation: a Cluster Randomized Trials
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
March 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aims and Objective: A theoretical model based on guided postoperative rehabilitation with feedback was developed for patients with lumbar intervertebral disc protrusion to explore the effects of feedback-based health education. Patients were assessed in terms of disease knowledge, general self-efficacy, medical behaviour, and the Oswestry disability index (ODI). During postoperative rehabilitation, nursing staff provided health education regarding lumbar intervertebral disc protrusion.
Detailed Description
Grouping method For the surgical treatment of lumbar intervertebral disc protrusion. The age of the included patients was greater than or equal to 18 years. Patients were cluster randomized by a coin toss into an experimental group that underwent spine surgery and a control group; 38 cases were included in each group for a total of 76 cases, and patients were assigned to the experimental and control groups in a 1:1 ratio, ensuring balance between groups. During implementation of the intervention, 1 patient in the control group voluntarily requested to withdraw from the study midway through the study, and the loss to follow-up rate was 2.6%. Finally, a total of 75 patients were included in this study, including 38 in the experimental group and 37 in the control group. 3 Test group (1) Implementation of the feedback method includes information transmission, patient feedback, clarification and correction, and confirmation of understanding ① Conveying health information Medical terms were transformed into plain language so that patients could easily understand the health education content. The feedback method was used to explain the pathogenesis of LDH as protrusion or degeneration of the collodium supporting the lumbar spine and rupture of the cartilage protecting the lumbar spine. The protruding collodium compresses the nerve root, leading to pain in the back and leg. Patient feedback After a health message was delivered, the patient was asked to repeat the information back in his own words with the following question: To make sure I'm clear, could you repeat the pathogenesis for me? ③ Educator clarification and correction If the patient had mastered the relevant information, the health education session was ended. If the patient understood some or no information, the steps were repeated, and the educator continued to explain the concept to the patient but changed the way he or she expressed it. ④ Checking understanding Finally, open questions such as the following were used to confirm the patient's understanding: Do you have any other questions? The patients were then given a chance to sort out the health information. (2) Patients in the test group received health education according to the feedback method, and the intervention contents and time were as follows: ① One day before surgery: Health education team members provided bedside one-on-one education for patients, 15-20 min per session, twice a day. Health education manuals and other tools were used to explain information related to lumbar intervertebral disc herniation, including the pathogenesis of LDH, clinical manifestations, the significance of relevant examinations, the principle of surgical treatment, and the importance of exercising according to the guidance of doctors, to the patient. The main problem before LDH was pain in the waist and legs, so the patients were advised to take medication and taught how to take neurotropin, mecobalamine, Celebrex and other drugs. One week after surgery: One-on-one education on rehabilitation exercise was conducted for the patients by the health education team members, 15-20 min per session, twice a day. Day of surgery: The main concerns of the patients were wound pain and axial rolling. After returning to the ward, the patients were taught about pain and the correct use of the analgesic pump. One week after surgery: The main concerns of the patients were waist circumference and methods of rehabilitation exercise. Patients were instructed to perform straight leg raising exercises, ankle pump exercises and quad contraction exercises, 10~20 times/session, 3 sessions/day. If the patient understood the relevant knowledge and completed the rehabilitation exercise, the patient was affirmed and encouraged in the form of award certificates, and the "Best Cooperation Award", "Best Progress Award", "Most Confidence Award", "Three Good Fellow Award", etc., were used to enhance the patient's self-confidence, sense of honour and sense of achievement in rehabilitation exercise. In terms of discharge guidance, patients were told to go home and continue to perform functional exercise. ③ Two to four weeks after surgery: The main concerns of patients were functional exercise and daily life activities. The health education group members guided the patients through functional rehabilitation exercises via WeChat. Each intervention lasted 20-30 min. The patients interacted once through WeChatB1, and their questions were answered at any time. Patients were instructed to perform head lifting training in the prone position, a wood rolling exercise, walking training (waist-assisted) and supine hip flexion and knee flexion exercises, 5-10 min/session, 3 sessions/day. Patients were required to sign in after receiving new exercises and give feedback. Patients were required to "send a video of themselves performing functional exercise to the group", and the health education team members corrected any incorrect movement or frequency, answered their questions, and confirmed whether they understood until they had fully mastered the correct methods for the functional exercise. WeChat pushed small pieces of information twice via a link. ④ Five to 12 weeks after surgery: the main concerns of patients were functional exercise methods, such as five-point support, and other matters needing attention. The health education group members guided patients through the functional rehabilitation exercises via WeChat. Each intervention lasted 20~30 min, and WeChat was used for both sessions. 4 Control group: The patients underwent routine health education.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Feedback method, Health education, Functional exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The methods were based on previous research on the feedback method of health education. A cluster randomized controlled trial design was used. From March 2019 to January 2020, patients who underwent spinal surgery at Tianjin Hospital were enrolled, and 76 met the inclusion criteria for lumbar disc disease (lumbar disc herniation, LDH). Patients were divided into an experimental group and a control group, with 38 patients in each group. Feedback-based health education was conducted for the experimental group, and routine health education was provided for the control group.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback-based health education health education and Routine health education
Arm Type
Experimental
Arm Description
Feedback-based health education:(1) Implementation of the feedback method includes information transmission, patient feedback, clarification and correction, and confirmation of understanding.① One day before surgery: Health education team members provided bedside one-on-one education for patients, 15-20 min per session, twice a day. ② One week after surgery: One-on-one education on rehabilitation exercise was conducted for the patients by the health education team members, 15-20 min per session, twice a day. ③ Two to four weeks after surgery: The health education group members guided the patients through functional rehabilitation exercises via WeChat. Each intervention lasted 20-30 min. The patients interacted once through WeChatB1, and their questions were answered at any time. ④ Five to 12 weeks after surgery: The health education group members guided patients through the functional rehabilitation exercises via WeChat.
Arm Title
Routine health education
Arm Type
Experimental
Arm Description
Routine health education: Routine health education was given to the patients, and the content of health education was the same as that of the experimental group, including the introduction of the disease, clinical manifestations, significance of examination, therapeutic principles of operative methods, psychological nursing, and postoperative rehabilitation exercise, etc. To verify the effect of health education by feedback method.
Intervention Type
Behavioral
Intervention Name(s)
Feedback-based health education
Intervention Description
This study was approved by the Tianjin Hospital Ethics Committee, (2019082).The CONSORT 2010 statement: extension to cluster-randomised trials checklist.(Campbell et al., 2012) was used to guide reporting outcomes (File S1).Specific measures have been listed above.
Intervention Type
Behavioral
Intervention Name(s)
Routine health education
Intervention Description
Routine health education was given to the patients, and the content of health education was the same as that of the experimental group, including the introduction of the disease, clinical manifestations, significance of examination, therapeutic principles of operative methods, psychological nursing, and postoperative rehabilitation exercise, etc. To verify the effect of health education by feedback method.
Primary Outcome Measure Information:
Title
General data
Description
The content includes general demographic and sociological data such as gender, age and education level, as well as basic information of diseases.
Time Frame
Day 1
Title
LDH knowledge questionnaire
Description
LDH knowledge questionnaire was prepared by Shi Yixin, with a total of 12 items. The questionnaire was scored by Likert 5, The minimum value is 1 point and the full score being 60 points. The higher the score, the better the patient's knowledge mastery. The content validity of knowledge questionnaire was 0.96 and Cronbach's α coefficient was 0.80.
Time Frame
Day 1 to week 12
Title
General Self-Efficacy Scale
Description
In this study, Wang Caikang translated Chinese version of scale general self-efficacy scale consists of 10 entries, beliefs about individual when facing difficulties or problems, adopt Likert level 4 score, each item from "completely incorrect" to "completely correct" respectively in 1 ~ 4 points, The minimum value is 1 point and the maximum value is 40 points, the higher the score shows that the higher the self-efficacy of the patients. The content validity of the scale was 0.87 and Cronbach's α coefficient was 0.83.
Time Frame
Day 1 to week 12
Title
Questionnaire on the compliance behaviour of LDH patients
Description
The questionnaire on compliance behavior of LDH patients was prepared by Shi Yixin, a researcher. The contents of the questionnaire included functional exercise, activities, diet, daily living, review, etc.The questionnaire adopts Likert 5 score, The minimum value is 1 point and the maximum value is 90 points. The higher the score, the better the compliance behavior of patients. The content validity of the questionnaire is 0.98, and Cronbach's α coefficient is 0.84.
Time Frame
Day 1 to week 12
Title
Oswestry disability index (ODI) scale
Description
This scale is widely used in China and internationally, and in the field of spinal medicine, it is recognized as the gold standard for evaluating curative effects and function . The scale was compiled in 1980 by Fairbank and colleagues and has been revised since ; it was first used in China after it was adapted by Zheng Guangxin . The scale is used to evaluate the efficacy of surgical treatment and is an important reference index in patients with lumbar disease.
Time Frame
Day 1 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of lumbar disc herniation Disease Must be able to Cooperate with research Exclusion Criteria: Lumbar malignant tumors, lumbar tuberculosis and osteoporosis People with mental system diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Rong Fan Rong, master
Organizational Affiliation
Tianjin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu College of Nursing
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
233005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20715962
Citation
Baretich M. National Quality Forum releases recommendations for safe practices. Biomed Instrum Technol. 2010 Jul-Aug;44(4):334-5. doi: 10.2345/0899-8205-44.4.334. No abstract available.
Results Reference
result

Learn more about this trial

Effect of Feedback Health Education on Postoperative Rehabilitation of Patients With Lumbar Disc Herniation

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