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

NCT06323694 | Completed

• 1 other identifier: Attesa chirurgia-1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spinal fusion; vertebroplasty; quality of life

Outcome Measures

Primary Outcomes (2)

• Descriptive survey for vertebroplasty patients

  questionnaire on the personal situation of the patient on the waiting list for vertebroplasty

  after 1 month

• Descriptive survey for spinal arthrodeses patients

  questionnaire on the personal situation of the patient on the waiting list for spinal arthrodeses

  after 1 year

Study Arms (2)

Patients with vertebroplasty

measuring the quality of life in patients on the waiting list for spinal surgery

Behavioral: quality of life

Patients with spinal fusion

measuring the quality of life in patients on the waiting list for spinal surgery

Behavioral: quality of life

Interventions

quality of life BEHAVIORAL

data collection through questionnaire and interview

Patients with spinal fusion; Patients with vertebroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients on the waiting list for first vertebral arthrodesis or vertebroplasty surgery percutaneous;
• Age over 18;
• Good understanding of spoken and written Italian;
• Obtaining Informed Consent;
• Possibility to go to the Rizzoli Orthopedic Institute on a date to be agreed for carry out the interview with the researchers.

You may not qualify if:

• Previous spinal surgery;
• Poor understanding of spoken and written Italian
• Central or peripheral neurological diseases;
• Systemic pathologies;
• Rheumatic pathologies;
• Neuromuscular pathologies;
• Tumors;
• Neuropsychological deficits that do not allow you to fill in the questionnaires and / or answer fully to the interview.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University of Bologna: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

• Pillastrini P, Ferrari S, Albano A, Beni M, Burbello I, De Cristofaro L, Griffoni C, Mattarozzi K, Nervuti G, Vanti C. Patients' experience on waiting for spinal arthrodesis: a qualitative study. Qual Life Res. 2025 Mar;34(3):833-842. doi: 10.1007/s11136-024-03861-3. Epub 2024 Dec 8.

  PMID: 39648235 DERIVED

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: March 21, 2024
• Study Start: May 15, 2022
• Primary Completion: January 25, 2024
• Study Completion: February 16, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)