Study Results
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Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-01-01
2026-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Josephine Zachodnik
PhD student
Principal Investigators
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Anja Geisler
Role: STUDY_DIRECTOR
Zealand University Hospital Koege
Locations
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Zealand University Hospital
Køge, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Louise Linding, RN
Role: backup
References
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Rajabiyazdi F, Alam R, Pal A, Montanez J, Law S, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Lee L, Feldman LS, Fiore JF Jr. Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery. JAMA Surg. 2021 Aug 1;156(8):758-765. doi: 10.1001/jamasurg.2021.1557.
Lee L, Tran T, Mayo NE, Carli F, Feldman LS. What does it really mean to "recover" from an operation? Surgery. 2014 Feb;155(2):211-6. doi: 10.1016/j.surg.2013.10.002. Epub 2013 Oct 12. No abstract available.
Mohamed Mohamed WJ, Joseph L, Canby G, Paungmali A, Sitilertpisan P, Pirunsan U. Are patient expectations associated with treatment outcomes in individuals with chronic low back pain? A systematic review of randomised controlled trials. Int J Clin Pract. 2020 Nov;74(11):e13680. doi: 10.1111/ijcp.13680. Epub 2020 Sep 7.
Krauss P, Sonnleitner C, Reinartz F, Meyer B, Meyer HS. Patient-Reported Expectations, Outcome and Satisfaction in Thoracic and Lumbar Spine Stabilization Surgery: A Prospective Study.Surgeries 2020; 1: 63-76.
Werner MU, Mjobo HN, Nielsen PR, Rudin A. Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0.
Frisaldi E, Shaibani A, Benedetti F. Why We should Assess Patients' Expectations in Clinical Trials. Pain Ther. 2017 Jun;6(1):107-110. doi: 10.1007/s40122-017-0071-8. Epub 2017 May 5.
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Gulur P, Nelli A. Persistent postoperative pain: mechanisms and modulators. Curr Opin Anaesthesiol. 2019 Oct;32(5):668-673. doi: 10.1097/ACO.0000000000000770.
Papadopoulos T, Abrahim A, Sergelidis D, Bitchava K. Original article Ερευνητική. 2011; 2: 119-23.
Heider D, Kitze K, Zieger M, Riedel-Heller SG, Angermeyer MC. Health-related quality of life in patients after lumbar disc surgery: a longitudinal observational study. Qual Life Res. 2007 Nov;16(9):1453-60. doi: 10.1007/s11136-007-9255-8. Epub 2007 Sep 12.
Kong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scienti c Requirements and Research Protocols. 2013; 29-32.
Alberts J, Lowe B, Glahn MA, Petrie K, Laferton J, Nestoriuc Y, Shedden-Mora M. Development of the generic, multidimensional Treatment Expectation Questionnaire (TEX-Q) through systematic literature review, expert surveys and qualitative interviews. BMJ Open. 2020 Aug 20;10(8):e036169. doi: 10.1136/bmjopen-2019-036169.
Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EXP - jzc - 2023
Identifier Type: -
Identifier Source: org_study_id
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