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

Lumbar Disc Herniation Clinical Trial

Official title:

Effect of Feedback Health Education on Postoperative Rehabilitation of Patients With Lumbar Disc Herniation: a Cluster Randomized Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885140
• Other study ID #: Jiangsu College of Nursing
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 4, 2021

Study information

• Verified date: May 2021
• Source: Tianjin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 4, 2021
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Behavioral:
• Feedback-based health education
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.
• 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.

Locations

Country	Name	City	State
China	Jiangsu College of Nursing	Huai'an	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

References Alessandro S, E S V, De Wispelaere Marlies P, et al. Tandem Disc Herniation of the Lumbar and Cervical Spine: Case Series and Review of the Epidemiological, Pathophysiological and Genetic Literature.[J]. Cureus, 2019,11(2):22. An H. Surgical [M

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 a coefficient was 0.80.	Day 1 to week 12
Primary	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 a coefficient was 0.83.	Day 1 to week 12
Primary	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 a coefficient is 0.84.	Day 1 to week 12
Primary	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