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The Effect of Respiratory Exercise After Laparoscopic Surgery

Primary Purpose

Laparoscopic Surgery, Breathing Exercise

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep-Breathing Exercises
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laparoscopic Surgery focused on measuring Laparoscopic Surgery, Breathing Exercise, Pain, Anxiety, Postoperative period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Agreeing to participate in the study verbally and in writing, 18 years and over, No neurological or psychological problems, Fluent in Turkish and able to communicate, No respiratory disease, Brought to the post-operative service, Planned cases, Patients who underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) under general anesthesia were included in the study. Exclusion Criteria: Those who do not accept to participate in the study verbally or in writing, Not 18 years of age or older Having neurological or psychological problems, Those who do not speak Turkish and cannot communicate Having respiratory disease Transferred to the intensive care unit after surgery, Emergency and unplanned cases Cases that converted from laparoscopic surgery to open surgery under general anesthesia were not included in the study.

Sites / Locations

  • Bartin Hospital of State

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

After the operation, breathing exercises will be applied to the patients.

There will be no intervention other than routine nursing care practices in the hospital.

Outcomes

Primary Outcome Measures

Measuring of anxiety
The effect of breathing exercise in patients after laparoscopic surgery using by State and Trait Anxiety Scale. The State-Trait Anxiety Inventory is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Secondary Outcome Measures

Respiratory parameters
The effect of deep breathing exercises on respiratory parameters in patients with laparoscopic surgery using a saturation device.
Measuring the level of nausea-vomiting
The effect of deep breathing exercises on nausea-vomiting in patients with laparoscopic surgery using by nausea severity scale.
Measuring the level of pain
The effect of deep breathing exercises on pain in patients with laparoscopic surgery using by Visual Analogue Scale.

Full Information

First Posted
November 10, 2022
Last Updated
November 17, 2022
Sponsor
Bartın Unıversity
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1. Study Identification

Unique Protocol Identification Number
NCT05624346
Brief Title
The Effect of Respiratory Exercise After Laparoscopic Surgery
Official Title
The Effect Of Respiratory Exercise After Laparoscopic Surgery On Pain, Anxiety, Nausea-Vomiting And Respiratory Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Laparoscopic surgery (LS) enables the patient to experience the desired result with smaller incisions in the postoperative period, more aesthetically, stress-free and less painful. This increases patient satisfaction and reduces morbidity and mortality. In the literature, it has been stated that respiratory exercises reduce the level of anxiety in different patient groups in the postoperative period and increase the quality of sleep and recovery. Among the duties and responsibilities of nurses working in surgical clinics are to provide breathing exercise training to patients in the preoperative period and to ensure that it is applied in the postoperative period. This study was planned to determine the effect of respiratory exercise applied to laparoscopic surgery patients on postoperative pain, anxiety, nausea-vomiting and respiratory parameters.
Detailed Description
Surgical intervention is a form of treatment applied to preserve the physiology of the organism as much as possible, and to normalize the body functions that are impaired in diseases and injuries. Laparoscopic surgery (LC) enables the patient to experience the desired result more aesthetically, stress-free and less painful with smaller incisions in the postoperative period. This increases patient satisfaction and reduces morbidity and mortality. It is made with small incisions without exposing large tissues, which is inevitable in LC surgery. Less tissue dissection provides a lower level of neuroendocrine and metabolic response to stress in humans. Postoperative pain and need for analgesia are reduced. It accelerates the recovery process of the patient and helps him return to daily life in a shorter time. It reduces the patient's hospital stay. It increases comfort and quality of life, provides less suppression of the immune system. LC has a lower mortality rate in addition to reducing the incidence of complications such as cosmetic problems, bleeding, injury, infection, inflammation, ileus. All these make LC more advantageous than other surgical methods. Pain, anxiety, nausea and vomiting are among the most common complications in the early postoperative period. In addition to pharmacological methods, non-pharmacological methods are also used to eliminate complications. Breathing exercise, which is the first step of relaxation, is one of the frequently used non-pharmacological methods. With breathing exercises, it is ensured that the respiratory rate and depth are regulated, the muscles of the assisted respiration relax, and the efficiency of respiration is increased. The most commonly used breathing exercises are pursed lip breathing (pursed lip breathing) and diaphragmatic breathing. Nurses should explain the steps of the procedure in the exercise applications in a way that the patient can understand and ensure that they practice the exercises regularly. Preoperative patient education, which can help prevent post-operative problems and early recovery; with explanation of surgical procedures, deep breathing, coughing, leg exercises, turning in bed, mobilization and reducing pain etc. includes topics. Among the duties and responsibilities of nurses working in surgical clinics are to provide breathing exercise training to patients in the preoperative period and to ensure its implementation in the postoperative period. Post-operative patients are not ready to learn anything new due to pain and other reasons. Therefore, these trainings should be completed before the surgery. The purpose of giving deep breathing and coughing exercises; Expanding the decreased lung capacity during and after anesthesia, restoring the perfusion-ventilation balance and regulating its distribution, increasing oxygenation, protecting the airways, and enabling the secretions in the airways to be expelled more easily with effective coughing. Teaching the breathing exercises, which is one of the basic duties of the surgical nurse, to the patients, explaining the importance of this and having it done regularly, increases the oxygenation of the tissues and affects the healing quality positively. In the literature, it has been stated that respiratory exercises reduce the level of anxiety and increase the quality of sleep and recovery in different patient groups in the postoperative period. Nurses should take an active role in diagnosing nausea, vomiting, pain and respiratory problems that may occur in the postoperative period, planning and applying the necessary pharmacological and non-pharmacological methods, monitoring and evaluating the results of treatment, and should be able to prevent problems that may develop. This study was planned to determine the effect of respiratory exercises on postoperative pain, anxiety, nausea-vomiting and respiratory parameters after laparoscopic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, Breathing Exercise
Keywords
Laparoscopic Surgery, Breathing Exercise, Pain, Anxiety, Postoperative period

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled experimental research
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
After the operation, breathing exercises will be applied to the patients.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
There will be no intervention other than routine nursing care practices in the hospital.
Intervention Type
Other
Intervention Name(s)
Deep-Breathing Exercises
Intervention Description
In addition to routine care in the hospital, the patient will be taught pre-operative breathing exercises. After surgery the patients do deep-breathing exercises every hour.
Primary Outcome Measure Information:
Title
Measuring of anxiety
Description
The effect of breathing exercise in patients after laparoscopic surgery using by State and Trait Anxiety Scale. The State-Trait Anxiety Inventory is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time Frame
Between 1-6 hours and 24 hours after surgery
Secondary Outcome Measure Information:
Title
Respiratory parameters
Description
The effect of deep breathing exercises on respiratory parameters in patients with laparoscopic surgery using a saturation device.
Time Frame
2nd, 6th, 12th and 24th hours after surgery
Title
Measuring the level of nausea-vomiting
Description
The effect of deep breathing exercises on nausea-vomiting in patients with laparoscopic surgery using by nausea severity scale.
Time Frame
2nd, 4th, 6th, 12th and 24th hours after surgery
Title
Measuring the level of pain
Description
The effect of deep breathing exercises on pain in patients with laparoscopic surgery using by Visual Analogue Scale.
Time Frame
2nd, 6th, 12th and 24th hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agreeing to participate in the study verbally and in writing, 18 years and over, No neurological or psychological problems, Fluent in Turkish and able to communicate, No respiratory disease, Brought to the post-operative service, Planned cases, Patients who underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) under general anesthesia were included in the study. Exclusion Criteria: Those who do not accept to participate in the study verbally or in writing, Not 18 years of age or older Having neurological or psychological problems, Those who do not speak Turkish and cannot communicate Having respiratory disease Transferred to the intensive care unit after surgery, Emergency and unplanned cases Cases that converted from laparoscopic surgery to open surgery under general anesthesia were not included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suna UZUN, Msc. Student
Organizational Affiliation
Bartın Unıversity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elif KARAHAN, Assoc. Prof.
Organizational Affiliation
Bartın Unıversity
Official's Role
Study Director
Facility Information:
Facility Name
Bartin Hospital of State
City
Bartin
State/Province
Merkez
ZIP/Postal Code
74100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Respiratory Exercise After Laparoscopic Surgery

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