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

NCT04885140 | Completed

• 1 other identifier: Jiangsu College of Nursing
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Feedback method; Health education; Functional exercise

Outcome Measures

Primary Outcomes (5)

• General data

  The content includes general demographic and sociological data such as gender, age and education level, as well as basic information of diseases.

  Day 1

• 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.

  Day 1 to week 12

• 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.

  Day 1 to week 12

• 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.

  Day 1 to week 12

• 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.

  Day 1 to week 12

Study Arms (2)

Feedback-based health education health education and Routine health education

EXPERIMENTAL

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.

Behavioral: Feedback-based health education

Routine health education

EXPERIMENTAL

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.

Behavioral: Routine health education

Interventions

Feedback-based health education BEHAVIORAL

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.

Feedback-based health education health education and Routine health education

Routine health education BEHAVIORAL

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.

Routine health education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Hospital: lead

Study Sites (1)

Jiangsu College of Nursing

Huai'an, Jiangsu, 233005, China

Location

Related Publications (1)

• 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.

  PMID: 20715962 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Health Education

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Fan Rong Fan Rong, master

  Tianjin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 13, 2021
• Study Start: March 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: March 4, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)