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

NCT ID: NCT06415890

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2025-07-15

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.

Conditions

Laparoscopic Cholecystectomy; Breathing Exercise; Pulmonary Function Test; Shoulder Pain; Surgical Nursing; 4-7-8 Breathing Technique

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Breathing Exercise Group

In addition to the routine treatment and care practices of the clinic, the patients included in the study group will be taught the 4-7-8 breathing technique by the researcher and applied after surgery. They will be provided to complete one set (4 breaths) by practicing the 4-7-8 breathing technique first with the researcher and then alone. The training will last approximately 15 minutes for each patient. Patients will be asked to start the first breathing exercise at the 4th hour after coming to the clinic after laparoscopic cholecystectomy and perform one set (4 breaths) every two hours.

Group Type: EXPERIMENTAL

4-7-8 Breathing Technique

Intervention Type: 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.

Control Group

Patients in the control group will receive routine treatment and care after laparoscopic cholecystectomy. In the clinic, patients are not trained on postoperative breathing exercises and the use of triflow is recommended. However, there is no planned training for the use of this tool and the patients' use of the tool is not monitored.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

4-7-8 Breathing Technique

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: collaborator

Mustafa Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Nur Serbest Baz

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay ALTUN UĞRAŞ

Role: STUDY_DIRECTOR

Mersin University

Locations

İskenderun Devlet Hastanesi

Hatay, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ayşe Nur SERBEST BAZ

Role: CONTACT

aysenurserbest@hotmail.com

03262213317

Gülay ALTUN UĞRAŞ

Role: CONTACT

gulaltun@mersin.edu.tr

03243610001

Facility Contacts

Demet Çalışkan

Role: primary

05458240933

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

HMKU-SERBEST-001

Identifier Type: -

Identifier Source: org_study_id