Clinical trial NCT06080997: Patients' Expectations Before Spinal Surgery
Official title: Patients' Expectations Before, and Their Experiences After Spinal Surgery, Regarding Pain, Rehabilitation and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Expectations
Surgery
Pain
Quality of Life
Keywords: Expectations
Pain
Rehabilitation
Quality of life
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at Zealand University Hospital, undergoing spinal surgery during 1 year, will be invited to participate in the study.

Brief summary: With this study the investigators want to perform a prospective observational cohort study at Zealand University Hospital, Koege, Denmark.

The purpose of this study is twofold:

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

Detailed description: Background Surgery can be an overwhelming and often 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, anaesthetists, 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 satisfaction in patients undergoing spinal surgery, and some evidence suggests 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.

This study 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, the study hypothesize that patients' preoperative expectations for spinal surgery can affect postoperative rehabilitation. Gaining an in-depth understanding of the process of recovery from the patient´s perspective can, ultimately, guide patient-centered care and future research.

Eligibility criteria: Inclusion Criteria:

Patients undergoing elective spinal surgery. Patients able to read and understand Danish.

Exclusion Criteria:

Patients with cognitive deficits, such as dementia. Patients with alcohol and drug dependence.

Primary outcomes:
measure: Expectations
timeFrame: Outcome measure will be assessed and presented 2025
measure: Patients Expectations
timeFrame: Outcome measure will be assessed and presented 2025
Secondary outcomes:
measure: Patients pain intensity
timeFrame: Outcome measure will be assessed and presented 2025
measure: Patients functional level
timeFrame: Outcome measure will be assessed and presented 2025
measure: Quality of life score
timeFrame: Outcome measure will be assessed and presented 2025
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Zealand
Study officials:
affiliation: Zealand University Hospital Koege
name: Anja Geisler
role: STUDY_DIRECTOR
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