Patients' Expectations Before Spinal Surgery

Sponsor

Zealand University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06080997

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With this study the investigators want to perform a prospective observational cohort study at Zealand University Hospital, Køge, Denmark.

The purpose of this study is twofold:

to investigate how expectations predict patients' pain, rehabilitation and quality of life after spinal surgery.
to explore the patients' expectations before, and their experiences after, spinal surgery regarding pain, rehabilitation and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Expectations Surgery Pain Quality of Life

Detailed Description

Background Surgery can be an overwhelming and often a life-changing experience for patients. To mitigate this experience a patient-centered approach can be beneficial. Patient-centered care is defined as providing care that is "respectful of and responsive to individual patient preferences, needs and values, and which ensures that patient values guide all clinical decisions". Patient-centeredness should be considered in discussions about the value of surgical treatment for the patient and the expectations regarding the process of postoperative rehabilitation, especially considering the patient's definition of a successful outcome. The meaning of rehabilitation may vary between stakeholders involved in surgery, including patients, surgeons, anesthetists, nurses, and hospital administrators. Studies addressing strategies to improve rehabilitation, such as minimally invasive surgery and enhanced recovery pathways, commonly focus on measures such as complication rates, gastrointestinal activity, physical function, and duration of hospital stay. These parameters are mostly relevant to clinicians and administrators, but they do not reflect the complexity of the rehabilitation process or include the patient's perspective and expectations.

In musculoskeletal practice, patients' expectations have been reported as a valuable predictor for treatment outcomes in patients with acute and chronic pain. Patients with higher expectations regarding the treatment report better outcomes than those with lower expectations. Previous studies have investigated the relationship between expectations and postoperative satisfactions in patients undergoing spinal surgery, and some evidence suggest patients' expectations also impact rehabilitation after surgery .

Patients undergoing spinal surgery usually suffer from moderate to severe pain during the perioperative and postoperative period, which is associated with developing persistent pain 8 and compromises patients' quality of life.

Lumbar disc herniation is one of the most common musculoskeletal diseases which, in some cases, can compromise patients' quality of life, and the most common operations performed on the spine. A previous study has shown that persistent pain after surgery for lumbar disc herniation is negatively associated with psychological and physical well-being, and the overall quality of life is decreased.

We hypothesize that interviewing patients in a semi-structured manner would give unique perspectives on what is important to patients, as opposed to what is important to researchers. Further, we hypothesize that patients' preoperative expectations for spinal surgery can affect postoperative rehabilitation. Gaining in-depth understanding of the process of recovery from the patients´ perspectives can, ultimately, guide patient-centered care and future research.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Patients' Expectations Before, and Their Experiences After Spinal Surgery, Regarding Pain, Rehabilitation and Quality of Life

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Spinal surgery No intervention will take place Recruiting autumn 2023 until autumn 2024. All patients at Zealand University Hospital, who meet the inclusion criteria, undergoing spinal surgery during 1 year, will be invited to participate in the quantitative part of the study. We estimate that 300 patients will be eligible for the quantitative part. For the qualitative part, we will include 10 - 15 patients undergoing spinal surgery.

Arm

Intervention/Treatment

Spinal surgery

No intervention will take place Recruiting autumn 2023 until autumn 2024. All patients at Zealand University Hospital, who meet the inclusion criteria, undergoing spinal surgery during 1 year, will be invited to participate in the quantitative part of the study. We estimate that 300 patients will be eligible for the quantitative part. For the qualitative part, we will include 10 - 15 patients undergoing spinal surgery.

Outcome Measures

Primary Outcome Measures

Expectations [Outcome measure will be assessed and presented 2025]
Expectations measured by Treatment Expectation Questionnaire TEX-Q pre-operatively and 3 month postoperatively
Patients Expectations [Outcome measure will be assessed and presented 2025]
Expectations measured by a semi-structured interview pre-operatively

Secondary Outcome Measures

Patients pain intensity [Outcome measure will be assessed and presented 2025]
Pain level measured by Verbal Rating Scale (VRS) pre-opertively and 3 month post-operatively
Patients functional level [Outcome measure will be assessed and presented 2025]
Functional level measured by Oswestry Disability Index (ODI) pre-opertively and 3 month post-operatively
Quality of life score [Outcome measure will be assessed and presented 2025]
Quality of life measured by WHO Quality of Life - BREF (WHOQOL-BREF) pre-opertively and 3 month post-operatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients > 18 years, undergoing elective spinal surgery at Zealand University Hospital, Koege. Patients able to read and understand Danish.

Exclusion Criteria:

Patients meeting one or more of the following criteria are ineligible for inclusion in the study. Patients with cognitive deficits, such as dementia or who are mentally disabled and cannot cooperate with the study based on the investigator's judgement. Patients with alcohol and drug dependence based on the investigator's judgement.