Rehabilitation Nursing Program in Otolaryngology

Rehabilitation Clinical Trial

Official title:

Rehabilitation Nursing Program in Otolaryngology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246891
• Other study ID #: University of Évora
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: University of Évora
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neck Cancer
• Otorhinolaryngologic Neoplasms
• Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Portugal	University of Évora	Évora

Sponsors (2)

Lead Sponsor	Collaborator
University of Évora	Instituto Portugues Oncologia de Lisboa Francisco Gentil

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Ahlberg A, Engström T, Nikolaidis P, Gunnarsson K, Johansson H, Sharp L, Laurell G. Early self-care rehabilitation of head and neck cancer patients. Acta Otolaryngol. 2011 May;131(5):552-61. doi: 10.3109/00016489.2010.532157. — View Citation

Clarke P, Radford K, Coffey M, Stewart M. Speech and swallow rehabilitation in head and neck cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S176-S180. — View Citation

Davidson A, Williams J. Factors affecting quality of life in patients experiencing facial disfigurement due to surgery for head and neck cancer. Br J Nurs. 2019 Feb 14;28(3):180-184. doi: 10.12968/bjon.2019.28.3.180. — View Citation

Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change is being assessed	Self-care: Barthel Index (0 points-100 points)	0 week - 4 weeks
Secondary	Impatient days	Days of hospitalization	0 week - 4 weeks