Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06323694
Other study ID # Attesa chirurgia-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2022
Est. completion date February 16, 2024

Study information

Verified date April 2024
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
quality of life
data collection through questionnaire and interview

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (2)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive survey for vertebroplasty patients questionnaire on the personal situation of the patient on the waiting list for vertebroplasty after 1 month
Primary Descriptive survey for spinal arthrodeses patients questionnaire on the personal situation of the patient on the waiting list for spinal arthrodeses after 1 year
See also
  Status Clinical Trial Phase
Completed NCT05023850 - Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block N/A
Completed NCT01251042 - Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood N/A
Completed NCT01356082 - CNAP™ Monitor Study N/A
Recruiting NCT04370951 - Efficacy of the Erector Spinae Plane Block in Posterior Thoraco- Lumbar Spinal Decompression Surgery N/A
Completed NCT03069794 - Effect of Spinal Surgery on the Posture and the Balance of the Patients Reached of Spinal Pathologies N/A
Recruiting NCT02595788 - Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound N/A
Completed NCT01855542 - The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries. N/A
Not yet recruiting NCT01299818 - Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome N/A
Recruiting NCT05417100 - Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery Phase 3
Completed NCT00491608 - Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis Phase 3
Terminated NCT03160170 - Efficacy of Suction Enabled Retraction Device N/A
Not yet recruiting NCT06466083 - Correlation Analysis of POD and PND in Elderly Spinal Surgery Patients Based on Rs-fMRI
Recruiting NCT06451627 - Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery N/A
Not yet recruiting NCT04922359 - Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults N/A
Recruiting NCT04189172 - MiDura-Study (Neuro-Patch in Duraplasty)
Recruiting NCT05553028 - Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery N/A
Completed NCT02892617 - Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery N/A
Completed NCT06118489 - Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Lung Mechanics
Recruiting NCT03512379 - Clinical Trial for the Application of Robotic System in Spinal Surgery N/A
Recruiting NCT03501810 - Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery