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Completed

NCT Number: NCT06428981

Surgical Intervention on the Body-mind-spirit of Patients With 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.

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Key information

Conditions

Cervical Spine Degeneration

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

degenerative cervical diseases

Other

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 outcomes

  1. Quality of life, mental health, pain relief, and spiritual health before surgery

    Time frame: Before surgery

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

  2. Quality of life, mental health, pain relief, and spiritual health before surgery

    Time frame: Before surgery

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

  3. Quality of life, mental health, pain relief, and spiritual health before surgery

    Time frame: Before surgery

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

  4. Quality of life, mental health, pain relief, and spiritual health before surgery

    Time frame: Before surgery

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

  5. Quality of life, mental health, pain relief, and spiritual health after surgery

    Time frame: six months after surgery

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

  6. Quality of life, mental health, pain relief, and spiritual health after surgery

    Time frame: six months after surgery

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

  7. Quality of life, mental health, pain relief, and spiritual health after surgery

    Time frame: six months after surgery

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

  8. Quality of life, mental health, pain relief, and spiritual health after surgery

    Time frame: six months after surgery

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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