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ExpectationsNCT06080997

Patients' Expectations Before Spinal Surgery

An observational study of Expectations and Surgery, run by Zealand University Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Expectations, Surgery, Pain
How many people
300 participants
Where
1 siteDenmark
Study dates
1 Jan 2024to 30 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients at Zealand University Hospital, undergoing spinal surgery during 1 year, will be invited to participate in the study.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Josephine Zachodnik contact

+45 47326316

jzc@regionsjaelland.dk

Anja Geisler contact

+45 23318446

agei@regionsjaelland.dk

Denmark1 site, 1 recruiting

  • Zealand University Hospital

    Køge, Region Sjælland, 4600

    Josephine Zachodnik, RN, +4547326316, jzc@regionsjaelland.dk

    Louise Linding, RN, +4547326316

    Recruiting

Other trials in Denmark

About this study

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

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.
Read the 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.

Keywords
Expectations, Pain, Rehabilitation, Quality of life
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06080997
Study groupRoleWhat they receive
Spinal surgeryNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expectations

    Expectations measured by Treatment Expectation Questionnaire (TEX Q) pre-operatively and 3 month postoperatively

    Measured: Outcome measure will be assessed and presented 2025

  2. Patients Expectations

    Expectations measured by a semi-structured interview pre-operatively

    Measured: Outcome measure will be assessed and presented 2025

Secondary outcomes (3)

  1. Patients pain intensity

    Pain level measured by Verbal Rating Scale (VRS) pre-operatively and 3 month post- operatively

    Measured: Outcome measure will be assessed and presented 2025

  2. Patients functional level

    Functional level measured by Oswestry Disability Index (ODI) pre-operatively and 3 month post-operatively

    Measured: Outcome measure will be assessed and presented 2025

  3. Quality of life score

    Quality of life measured by WHO Quality of Life - BREF (WHOQOL-BREF) pre-opertively and 3 month post-operatively

    Measured: Outcome measure will be assessed and presented 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Jan 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06080997
Sponsor's protocol ID
EXP - jzc - 2023
Status last verified
Feb 2025
First submitted
6 Oct 2023
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33978692

  • 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.

    PubMed 24331759

  • 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.

    PubMed 33166045

  • 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.

    PubMed 20460988

  • 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.

    PubMed 28477082

  • 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.

    PubMed 23392233

  • Gulur P, Nelli A. Persistent postoperative pain: mechanisms and modulators. Curr Opin Anaesthesiol. 2019 Oct;32(5):668-673. doi: 10.1097/ACO.0000000000000770.

    PubMed 31343465

  • 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.

    PubMed 17849238

  • 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.

    PubMed 32819942

  • 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.

    PubMed 14769454

Questions about this trial

What is this clinical trial studying?

An observational study of Expectations and Surgery, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Josephine Zachodnik (+45 47326316, jzc@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expectations (time frame: Outcome measure will be assessed and presented 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06080997, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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