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Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery

NCT06323694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-04-16

No results posted yet for this study

Summary

The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.

Hypothesis:

Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.

This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.

The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.

The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.

All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.

The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority.

Conditions

  • Spinal Surgery

Interventions

BEHAVIORAL

quality of life

data collection through questionnaire and interview

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • Istituto Ortopedico Rizzoli

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2024-01-25
Completion
2024-02-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06323694 on ClinicalTrials.gov