Clinical trial NCT04885140: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Feedback method
Health education
Functional exercise
Lead sponsor: Tianjin Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: General data
timeFrame: Day 1
measure: LDH knowledge questionnaire
timeFrame: Day 1 to week 12
measure: General Self-Efficacy Scale
timeFrame: Day 1 to week 12
measure: Questionnaire on the compliance behaviour of LDH patients
timeFrame: Day 1 to week 12
measure: Oswestry disability index (ODI) scale
timeFrame: Day 1 to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Jiangsu College of Nursing
state: Jiangsu
Study officials:
affiliation: Tianjin Hospital
name: Fan Rong Fan Rong, master
role: PRINCIPAL_INVESTIGATOR
References:
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.