## Protocol Section
### Identification Module
**NCT ID:** NCT06428981

**Brief Title:** Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery

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

#### Organization Study ID Info
**ID:** 202200381B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-26

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-02

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chang Gung Memorial Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cervical Spine Degeneration

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: degenerative cervical diseases

**Label:** spine surgery

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- spine surgery

**Description:** 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.

**Name:** degenerative cervical diseases

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) before surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery

**Time Frame:** Before surgery

**Description:** The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale before surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery

**Time Frame:** Before surgery

**Description:** The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale before surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery

**Time Frame:** Before surgery

**Description:** The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery

**Time Frame:** Before surgery

**Description:** The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) six months after surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery

**Time Frame:** six months after surgery

**Description:** The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale six months after surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery

**Time Frame:** six months after surgery

**Description:** The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale six months after surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery

**Time Frame:** six months after surgery

**Description:** The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.

**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery

**Time Frame:** six months after surgery

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 100 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kaohsiung

**Country:** Taiwan

**Facility:** Kaohsiung Chang Gung Memorial Hospital

**Zip:** 83301

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
