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Laparoscopic SurgeryNCT05624346

The Effect of Respiratory Exercise After Laparoscopic Surgery

A study testing Deep-Breathing Exercises in people with Laparoscopic Surgery and Breathing Exercise, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Laparoscopic Surgery, Breathing Exercise
What is being tested?
Deep-Breathing Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Sep 2022to 25 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bartin Hospital of State

    Bartın, Merkez, 74100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Respiratory Exercise After Laparoscopic Surgery On Pain, Anxiety, Nausea-Vomiting And Respiratory Parameters

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.

Read more

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.

Read the 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.

Being tested
Deep-Breathing Exercises
Keywords
Laparoscopic Surgery, Breathing Exercise, Pain, Anxiety, Postoperative period
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep-Breathing ExercisesOther

    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.

Study groups in NCT05624346
Study groupRoleWhat they receive
Experimental GroupExperimentalAfter the operation, breathing exercises will be applied to the patients.
Receives: Other: Deep-Breathing Exercises
Control GroupNo interventionThere will be no intervention other than routine nursing care practices in the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Between 1-6 hours and 24 hours after surgery

Secondary outcomes (3)
  1. Respiratory parameters

    The effect of deep breathing exercises on respiratory parameters in patients with laparoscopic surgery using a saturation device.

    Measured: 2nd, 6th, 12th and 24th hours after surgery

  2. 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.

    Measured: 2nd, 4th, 6th, 12th and 24th hours after surgery

  3. Measuring the level of pain

    The effect of deep breathing exercises on pain in patients with laparoscopic surgery using by Visual Analogue Scale.

    Measured: 2nd, 6th, 12th and 24th hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start26 Sep 2022
  3. Primary completion22 Aug 2023
  4. Study completion25 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized controlled experimental research
Masking
Single blind
Who is masked
Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624346
Sponsor's protocol ID
2022-SBB-0086
Status last verified
Nov 2023
First submitted
10 Nov 2022
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Deep-Breathing Exercises in people with Laparoscopic Surgery and Breathing Exercise, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring of anxiety (time frame: Between 1-6 hours and 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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