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

Cervical Spine Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06428981
• Other study ID #: 202200381B0
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: February 26, 2024

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 26, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spine Degeneration

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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