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NCT Number: NCT06415890

Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after laporoscopic cholecystectomy. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İskenderun Devlet Hastanesi

Hatay, 31000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Demet Çalışkan

CONTACT

05458240933

About this study

Laporoscopic cholecystectomy (LC) is the most commonly used method for the treatment of cholecystitis, one of the most common diseases of the digestive system. In addition to its advantages such as low risk of complications and usually requiring less than 24 hours of hospitalization, shoulder pain develops in approximately 35-80% of patients after LC. After LK, patients' lungs may be affected due to factors such as intraoperative general anesthesia, mechanical ventilation support, carbon dioxide (CO2) pneumoperitoneum administration, anesthetic drugs and patient positioning, and patients experience shoulder pain, especially with CO2 pneumoperitoneum administration. In patients undergoing LK, shoulder pain felt throughout the thorax causes spasm and restriction of movement in the muscles assisting respiration and an increase in intercostal tone. This leads to a decrease in the amount of air filling the lungs, accumulation of secretions, pneumonia, decreased functional residual volume and increased risk of atelectasis. For this reason, it is necessary to evaluate the respiratory system in patients undergoing LK as in all surgical interventions and to monitor pulmonary functions (FVC, FEV1, FEV1/FCV) to evaluate the deterioration in lung functions and to control pain with pharmacologic and non-pharmacologic methods. One of the respiratory exercises that nurses can apply independently in the removal of CO₂, improvement of respiratory functions and pain control after surgery is the 4-7-8 breathing technique. This technique has been proven to have positive contributions in pain control, and its easy application, reliability and non-invasiveness make its use widespread.

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after LK. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing elective laparoscopic cholecystectomy,
  • Admitted to the clinic at least 2 hours before the surgical procedure,
  • Open to communication and cooperation,
  • Written and verbal permission to participate in the study was obtained,
  • Conscious, oriented and cooperative,
  • No cognitive and mental problems,
  • Speaks and understands Turkish,
  • American Society of Anesthesiologists (ASA) classification scores of I and II,
  • Hospitalized at least one night after surgical intervention,
  • Patients aged 18 years and older will be included in the study.

Exclusion criteria

  • Undergoing emergency laparoscopic cholecystectomy,
  • Open cholecystectomy,
  • Not admitted to the clinic at least 2 hours before the surgical procedure,
  • Not open to communication and cooperation,
  • Written and verbal permission to participate in the research could not be obtained,
  • Unconscious, disoriented and uncooperative,
  • Cognitively and mentally impaired,
  • Speaking Turkish but not understanding it,
  • Discharged on the same day after surgical intervention,
  • ASA score III and above,
  • Patients aged 18 years and younger will not be included in the study.

Treatment and study plan

4-7-8 Breathing Technique

Other

The 4-7-8 breathing technique to be applied to the patients in the experimental group; the patient will be asked to sit or lie in a comfortable position with his/her hands on his/her lap, press the tip of his/her tongue on the tissue protrusion behind the upper front teeth and hold it there during the breathing cycle, breathe in through the nose for four counts, hold the breath for seven counts and then slowly exhale through the mouth for eight counts and complete a set. Within one set of practice, this cycle repeats four times.

Primary outcomes

  1. Shoulder Pain

    Time frame: Second postoperative day

    Visual Analog Scale (VAS):The VAS used in this study is a one-dimensional pain scale commonly used in adult populations. The VAS is a continuous scale consisting of a horizontal or vertical line 10 centimeters (100 mm) long. Pain intensity is determined by statements ranging from "no pain" at one end of the scale to "excruciating pain" at the other end. The participant is asked to place a line perpendicular to the VAS line at the point representing pain intensity. Pain scoring is determined by measuring the distance (mm) on the 10-centimeter line using a ruler and is defined by providing a score range between 0-100 mm (No pain=0-4 mm, mild pain=5-44 mm, moderate pain=45-74 mm and severe pain=75-100 mm). In this study, the vertical form of the VAS will be used to evaluate shoulder pain in patients after surgical intervention based on the information that the vertical form of the VAS gives more accurate results than the horizontal form

    Translated with DeepL.com (free version)

  2. Pulmonary Function Test

    Time frame: Second postoperative day

    Pulmonary Function Test: Pulmonary function values will be evaluated with a portable . FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used in the evaluationpulmonary function test device.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Nur SERBEST BAZ

CONTACT

[email protected]

03262213317

Gülay ALTUN UĞRAŞ

CONTACT

[email protected]

03243610001

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Collaborators

  • Mersin University

Registry information

Official study title

The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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