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临床试验/NCT03999671
NCT03999671已完成不适用

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

Instituto Mexicano del Seguro Social0 个研究点目标入组 400 人开始时间: 2016年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
主要终点
Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation

研究概览

简要总结

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.

详细描述

Patients admitted to the Cardiology Hospital, National Medical Center Century XXI, will be included and a permanent pacemaker will be installed due to alterations in atrio-ventricular conduction that meet the selection criteria. They will be explained what the research consists of and they will be given an informed consent form to participate in the study, with all the ethical considerations that we will discuss later.

they require to control their comorbidities according to the assessment of their treating physician. Having accepted their participation in the present research project, the first evaluation (Time 0) will be conducted through an interview with the instrument SF36 Spanish version containing a total of 36 questions, translated into several languages and applied to multiple studies in Mexico for its validation. The interview will be conducted in two parts and will last approximately 15 to 20 minutes.

Once the first evaluation has been carried out, they will randomly assign, through the use of random number tables, to receive specific care from the nursing staff in the following manner:

I. Group of conventional nursing intervention (Group I) that refers to the form performed up to now, hemodynamic assessment, local pacemaker verification, electrocardiographic tracing, surveillance and care of the incision, assessment of symptoms after the insertion of the pacemaker, risks and interferences, mobilization and posture, complications, care information and identification of other needs of the elderly in terms of mobility, degree of dependency, pain assessment, elimination, nutritional, rest and relationship difficulties family, work, emotional conflicts, values and religiosity in some cases.

II. Nursing intervention group through the nursing process with the Marjory Gordon system (Group II).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Maneuver control (Other)

Checklist

Active Comparator

Verify that the interventions of both groups were carried out

干预措施: Educational (Other)

Checklist

Active Comparator

Verify that the interventions of both groups were carried out

干预措施: Maneuver control (Other)

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.

干预措施: Educational (Other)

结局指标

主要结局

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

时间窗: one year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sonia Gonzalez Mejorada

Principal Investigator

Instituto Mexicano del Seguro Social

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