Clinical trial NCT06415890: Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy
Official title: The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Breathing Exercise
Pulmonary Function Test
Shoulder Pain
Surgical Nursing
4-7-8 Breathing Technique
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2024-05-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a prospective, two-arm randomized controlled clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder Pain
timeFrame: Second postoperative day
measure: Pulmonary Function Test
timeFrame: Second postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: İskenderun Devlet Hastanesi
Study officials:
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ
role: STUDY_DIRECTOR
References:
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