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

(Holistic Health Care) Influence of Surgical Intervention on the Body-mind-spirit of Patients Undergoing Cervical Spine Surgery

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 Overview

• Status: Completed
• Conditions: Cervical Spine Degeneration
• Intervention / Treatment: Other: degenerative cervical diseases

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: spine surgery; 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life, mental health, pain relief, and spiritual health before surgery	The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) before surgery.	Before surgery
Quality of life, mental health, pain relief, and spiritual health before surgery	The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale before surgery.	Before surgery
Quality of life, mental health, pain relief, and spiritual health before surgery	The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale before surgery.	Before surgery
Quality of life, mental health, pain relief, and spiritual health before surgery	The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.	Before surgery
Quality of life, mental health, pain relief, and spiritual health after surgery	The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) six months after surgery.	six months after surgery
Quality of life, mental health, pain relief, and spiritual health after surgery	The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale six months after surgery.	six months after surgery
Quality of life, mental health, pain relief, and spiritual health after surgery	The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale six months after surgery.	six months after surgery
Quality of life, mental health, pain relief, and spiritual health after surgery	The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.	six months after surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202200381B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No