Use of Electroanalgesia in Pain and Pulmonary Function.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-10-30

Brief Summary

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It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

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Detailed Description

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This is an uncontrolled cross-sectional clinical trial with a sample of 66 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes. Through this research, it is expected that the patients who perform TENS present a reduction in postoperative pain and, consequently, a lower impact on lung function.

Conditions

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Bariatric Surgery Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an uncontrolled cross-sectional clinical trial with a sample of 132 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

He sample will consist of 132 individuals, of both men and women, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia via TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia. For division of groups, a sortition will be carried out through envelopes where it will be decided to which study group the patient will be allocated.

Study Groups

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No Electroanalgesia

The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Electroanalgesia

The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia

Group Type EXPERIMENTAL

Experimental: Electroanalgesia

Intervention Type OTHER

The sample will consist of 66 individuals, of both men and women, where they will be randomly included in two groups: Intervention group composed of 33 patients who will effectively receive the treatment through electroanalgesia via TENS;

Interventions

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Experimental: Electroanalgesia

The sample will consist of 66 individuals, of both men and women, where they will be randomly included in two groups: Intervention group composed of 33 patients who will effectively receive the treatment through electroanalgesia via TENS;

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* This research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over

Exclusion Criteria

* Patients over the age of 50;
* Individuals who present hemodynamic instability in the postoperative period;
* Use of mechanical ventilation for more than 24 hours;
* Contraindications regarding the use of TENS (presence of a cardiac pacemaker, hypersensitivity regarding the use of TENS);
* Previous history of epilepsy;
* Pregnant women during the first trimester;
* Patients with a score, on the Glasgow coma scale (Appendix I), less than 15;
* Patients who choose to withdraw during the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes