Rehabilitation Nursing Program in Otolaryngology

Sponsor
University of Évora (Other)
Overall Status
Completed
CT.gov ID
NCT05246891
Collaborator
Instituto Portugues Oncologia de Lisboa Francisco Gentil (Other)
151
1
30
5

Study Details

Study Description

Brief Summary

The European Commission's current political guidelines demonstrate into a joint plan aimed at improving and controlling cancer disease. Head and neck cancer (HNC) are the sixth most common cancer worldwide. The surgery is one of the most effective treatments, however it significantly compromises the self-care and functional capacity of the patients, so the intervention the Rehabilitation Nurse (RN) is essential.

Objective: Compare the degree of dependence in discharge from patients undergoing HNC surgery with RN intervention versus general nursing care (not RN intervention). The specific objective is to analyze the role of confounders in the effect of the RN intervention on the patient dependence.

Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72).

Condition or Disease Intervention/Treatment Phase
  • Other: rehabilitation nursing

Detailed Description

Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72). Differences between groups were calculated using non-parametric tests Chi-square for categorical variables and Mann-Whitney U for numeric variable. After correlation tests between variables, statistical analysis was carried out through Poisson regression to a significance level of 5%.

Study Design

Study Type:
Observational
Actual Enrollment :
151 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Rehabilitation Nursing Program in Otolaryngology
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Rehabilitation nursing intervention

Functional respiratory rehabilitation exercise plan. Motor exercise plan. Cardiorespiratory optimization. Early diagnosis of potential problems associated.

Other: rehabilitation nursing
Functional respiratory rehabilitation and motor exercise plan.

Rehabilitation nursing not intervention

General nursing care

Other: rehabilitation nursing
Functional respiratory rehabilitation and motor exercise plan.

Outcome Measures

Primary Outcome Measures

  1. Change is being assessed [0 week - 4 weeks]

    Self-care: Barthel Index (0 points-100 points)

Secondary Outcome Measures

  1. Impatient days [0 week - 4 weeks]

    Days of hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Undergoing a different type of surgery: 1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy.
Exclusion Criteria:
  • Participants will be excluded if not be possible access of the clinical information.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Évora Évora Portugal 7000

Sponsors and Collaborators

  • University of Évora
  • Instituto Portugues Oncologia de Lisboa Francisco Gentil

Investigators

  • Principal Investigator: José JM Moreira, MSc, University of Évora

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
José Manuel Afonso Moreira, Principal Investigator, University of Évora
ClinicalTrials.gov Identifier:
NCT05246891
Other Study ID Numbers:
  • University of Évora
First Posted:
Feb 18, 2022
Last Update Posted:
Mar 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by José Manuel Afonso Moreira, Principal Investigator, University of Évora
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022