Effect of the Nursing Process on the Quality of Life of the Patient With Definitive Pacemaker Implantation

NCT03999671 | Completed DMC

• 1 other identifier: R-2013-3604-7
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The nursing process consists of establishing interventions applying the scientific method for the resolution of real or potential health problems of the person, based on five stages: assessment, diagnosis, planning, execution and evaluation, which allows detecting the circumstances and elements that affect the adult's independence and the influence he has on his environment, his quality of life, his family, social and psychological role. MATERIAL AND METHODS: Clinical trial, randomized, controlled with standard management; to evaluate the effect of the nursing process on the quality of life in elderly patients who come or are referred to the Cardiology Hospital, National Medical Century XXI, with alterations in the ventricular atrial conduction and require the installation of a permanent pacemaker. The first evaluation (Time 0) will be carried out through an interview with the SF36 instrument, translated into several languages and applied to multiple studies in Mexico for validation. Two groups will be formed for comparison: Group I will be assigned to standard management; Group II: group of patients who are also treated through the nursing process with the model of Marjory Gordon with the intervention Handling the definitive pacemaker with education and information activities. It will be verified for quality control of the maneuver; through a checklist. As a final point, the quality of life will be evaluated through the use of the SF36 instrument that consists of 36 items that explore 8 dimensions of the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being; applying the assessment system of the functional patterns of the Marjory Gordon model, through surveys. Statistical analysis: Chi square or Fisher's exact test will be used according to expected values, for qualitative variables. For quantitative variables, the Mann Whitney U or Student's T according to their distribution. There will be a calculation of the number needed to be treated, and a multivariate analysis will be carried out using a binary logistic regression.

Conditions

Quality of Life

Keywords

Effect, Nursing, Process, Functional, Patterns,health

Outcome Measures

Primary Outcomes (1)

• Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation

  To determine the effect of the nursing process through the functional patterns on the quality of life of the elderly adult patient with definitive pacemaker implantation.

  one year

Study Arms (2)

INSTRUMENT SF 36

EXPERIMENTAL

Instrument SF36 Spanish version, validated in Spain, translated in several languages and applied to multiple studios in Mexico. The 36 items explore 8 dimensions: the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being.

Other: Educational; Other: Maneuver control

Checklist

ACTIVE COMPARATOR

Verify that the interventions of both groups were carried out

Other: Educational; Other: Maneuver control

Interventions

Educational OTHER

Traditional method of nursing care with what is done every day, with the method through the nursing process using nursing language as a nursing diagnosis, classification of nursing interventions, and nursing outcomes.

Checklist; INSTRUMENT SF 36

Maneuver control OTHER

Verify that the control and intervention group developed the assigned activities in each case.

Checklist; INSTRUMENT SF 36

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 60 years old
• Any gender
• That require the placement of a definitive pacemaker either by endocardial or epicardial route and do not present any complication during its installation and hospital stay.
• Signature of informed consent in writing of acceptance to enter the study

You may not qualify if:

• Older adults with neurological problems.
• Patients with other aggregate pathologies different from atrio-ventricular conduction abnormalities such as valvular diseases, myocardial infarction, congenital diseases, postoperative atrio-ventricular blocks, neoplastic diseases, end-stage renal disease.
• Generator depletion.
• Endocarditis.
• Chronic degenerative diseases whose life expectancy is less than 2 years.
• Previous pacemaker carrier and that you enter for replacement.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Officials

• SONIA GONZALEZ MEJORADA

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group and intervention group, were selected randomly from consecutive cases and standard management

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 27, 2019
• Study Start: June 25, 2016
• Primary Completion: July 25, 2017
• Study Completion: June 25, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06