NCT06080997

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2024Nov 2026

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

October 6, 2023

Last Update Submit

February 17, 2025

Conditions

ExpectationsSurgeryPainQuality of Life

Keywords

ExpectationsPainRehabilitationQuality of life

Outcome Measures

Primary Outcomes (2)

  • Expectations

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

    Outcome measure will be assessed and presented 2025

  • Patients Expectations

    Expectations measured by a semi-structured interview pre-operatively

    Outcome measure will be assessed and presented 2025

Secondary Outcomes (3)

  • Patients pain intensity

    Outcome measure will be assessed and presented 2025

  • Patients functional level

    Outcome measure will be assessed and presented 2025

  • Quality of life score

    Outcome measure will be assessed and presented 2025

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Related Publications (13)

  • 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.

    PMID: 33978692BACKGROUND

  • 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.

    PMID: 24331759BACKGROUND

  • 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.

    PMID: 33166045BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20460988BACKGROUND

  • 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.

    PMID: 28477082BACKGROUND

  • 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.

    PMID: 23392233BACKGROUND

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

    PMID: 31343465BACKGROUND

  • Papadopoulos T, Abrahim A, Sergelidis D, Bitchava K. Original article Ερευνητική. 2011; 2: 119-23.

    BACKGROUND

  • 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.

    PMID: 17849238BACKGROUND

  • Kong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scienti c Requirements and Research Protocols. 2013; 29-32.

    BACKGROUND

  • 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.

    PMID: 32819942BACKGROUND

  • 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.

    PMID: 14769454BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anja Geisler

    Zealand University Hospital Koege

    STUDY DIRECTOR

Central Study Contacts

Josephine Zachodnik

CONTACT

+45 47326316jzc@regionsjaelland.dk

Anja Geisler

CONTACT

+45 23318446agei@regionsjaelland.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

January 1, 2024

Primary Completion

September 30, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

DK(1)