Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery

Not Applicable

Completed

• Conditions: Cervical Spine Degeneration
• Interventions: Other: degenerative cervical diseases

• Registration Number: NCT06428981
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Detailed Description

Degenerative cervical disease induces cervical radiculopathy and myelopathy, which have a significant impact on the patients' health. The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-08-02
• Primary Completion: 2023-12-30
• Study Completion: 2024-02-26
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

Exclusion Criteria

• Patients who were unable to attend follow-up visits or complete the questionnaires, and those patients who expressed doubts or were unable to provide satisfactory responses regarding the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
spine surgery	degenerative cervical diseases	The inclusion criteria consisted of patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

Primary Outcome Measures

Name	Time	Method
Quality of life, mental health, pain relief, and spiritual health before surgery	Before surgery	The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.
Quality of life, mental health, pain relief, and spiritual health after surgery	six months after surgery	The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan