Zealand University Hospital
Køge, Region Sjælland, 4600, Denmark
Location status: Recruiting
Location contact
Josephine Zachodnik, RN
CONTACT
Louise Linding, RN
CONTACT
NCT Number: NCT06080997
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Køge, Region Sjælland, 4600, Denmark
Location status: Recruiting
Josephine Zachodnik, RN
CONTACT
Louise Linding, RN
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Time frame: Outcome measure will be assessed and presented 2025
Expectations measured by Treatment Expectation Questionnaire (TEX Q) pre-operatively and 3 month postoperatively
Time frame: Outcome measure will be assessed and presented 2025
Expectations measured by a semi-structured interview pre-operatively
Time frame: Outcome measure will be assessed and presented 2025
Pain level measured by Verbal Rating Scale (VRS) pre-operatively and 3 month post- operatively
Time frame: Outcome measure will be assessed and presented 2025
Functional level measured by Oswestry Disability Index (ODI) pre-operatively and 3 month post-operatively
Time frame: 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
Contact information is provided by the study sponsor or research team.
Anja Geisler
CONTACT
Josephine Zachodnik
CONTACT
Zealand University Hospital
Other
Patients' Expectations Before, and Their Experiences After Spinal Surgery, Regarding Pain, Rehabilitation and Quality of Life
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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