Effects of the 4-7-8 Breathing Technique on Postoperative Pain Scores, Anxiety, and Sleep Quality in Patients

NCT ID: NCT07303634

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-02-01

Brief Summary

This study aims to evaluate the effects of teaching the 4-7-8 breathing technique, one of the deep breathing techniques, to patients undergoing laparoscopic cholecystectomy surgery and applying it during the preoperative and postoperative periods on postoperative pain levels, anxiety levels, and sleep quality. Secondary objectives are to evaluate patients' postoperative peripheral oxygen saturation and length of hospital stay.

Patients will be randomized into two groups using a closed opaque envelope technique, and the groups will be determined. This procedure will be performed by a researcher not involved in the study. Patients undergoing Laparoscopic Cholecystectomy will be randomized. The groups will be coded as A and B. Group A patients will be instructed to practice the 4-7-8 breathing technique for 6 hours per day, 10 cycles per hour, during the preoperative and postoperative periods after receiving training. Group B will be the control group, and routine follow-ups will be performed on these patients. Participants' correct and regular application of the breathing technique will be verified through a short test after training and follow-up calls. Participants will be given an "Informed Consent Form," and their consent will also be obtained not to interact with each other or share group information. The perioperative process will be monitored by anesthesiologists not involved in the study.

Detailed Description

The study is planned to be conducted at the Anesthesiology and Resuscitation Clinic of Beyhekim Training and Research Hospital with hospital ethics committee approval and informed patient consent. A total of 100 patients aged 18-65 years in ASA I-III groups, 50 patients per group, will undergo laparoscopic cholecystectomy.

Inclusion criteria for the study

1. Participants must be informed and give voluntary consent to participate in the study.

2. Patients who have undergone laparoscopic cholecystectomy.

3. Patients with an ASA physical performance score of 1-3.

4. Patients aged 18-65 years. Exclusion criteria

1) Patients who do not wish to continue participating in the study 2) Deterioration in the medical condition of patients. 3) Those with a history of medication use accompanied by depression and other psychiatric diagnoses 4) Those with a history of substance abuse 5) Those with respiratory tract infection or pathology (Asthma, COPD) 6) Patients with neuromuscular disorders 7) Patients under 18 years of age 8) Patients who cannot read or write Turkish or who are uncooperative 9) Patients unable to comply with breathing training techniques 10) Conversion from laparoscopic to open surgery Preoperative procedures Patients who receive breathing technique training prior to surgery will be asked to practice the 4-7-8 breathing technique for 6 hours, 10 cycles per hour, the day before surgery. In this technique, patients sit with their backs straight and place the tip of their tongue behind their upper front teeth. They count to four while taking a deep breath through their nose, then hold their breath while counting to seven, and finally exhale slowly through their mouth while counting to eight, preferably accompanied by a slight humming sound. The cycle is repeated three more times for a total of four breaths.

In our clinical practice, 1 mg of midazolam will be administered intravenously as standard premedication to patients admitted to the operating room. Standard monitoring procedures will include electrocardiography (ECG), peripheral oxygen saturation (SpO2), and noninvasive arterial blood pressure measurements during the procedure.

Study Design According to randomization, all patients will receive a standard general anesthesia protocol administered by anesthesiologists with at least 5 years of clinical experience who are blinded to the randomization. These patients will undergo preoxygenation with 2 minutes of 4 L/min mask ventilation in the supine position on the operating table.

During anesthesia induction, 2 mg/kg propofol (Propofol%1-Fresenius®, Fresenius Kabi), 0.6 mg/kg rocuronium (Esmeron), and 1 μg/kg fentanyl (Talinat) were administered. Anesthesia maintenance will be provided with remifentanil 0.1-0.2 μg/kg/min infusion, 40% O2 with 60% air, and sevoflurane (MAC 1-2%) inhalation.

All patients will undergo routine laparoscopic cholecystectomy surgery. The perioperative intravenous analgesic drugs used in both groups were 50 mg dexketoprofen (2 ml ampoule) and 1 gram paracetamol (100 ml vial). All patients will be decubated and extubated by administering 2-4 mg/kg intravenous sugammadex. Patients with a monitored tetrodotoxin response (TOF) >0.9 will be included in the evaluation (Benevision N15, Shenzhen Mindray, China).

Data on the groups will be collected by other anesthesiologists in the postoperative period at 1 hour, 4 hours, 12 hours, and 24 hours, as well as the Hospital Anxiety and Depression Scale (HADS) and the Richard-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1. Data analysis will be performed by a statistician.

Measurements to be Applied in the Study Visual Analog Score (VAS) is one of the most commonly used pain assessment scales in practice. Patients participating in the study will be instructed to report their pain on a scale from 0 (no pain) to 10 (the most severe pain they can describe).

The Hospital Anxiety and Depression Scale was developed to identify anxiety disorders and depression in patients in hospital clinics outside of psychiatry. The HADS is short and easy to score and is widely used in adults. These subscales, each consisting of 7 items, assess both anxiety and depression symptoms with a total of 14 items. Responses are scored on a four-point Likert scale ranging from 0 to 3. Anxiety Score results of 10 or above may indicate Generalized Anxiety Disorder. A Depression Score of 7 or higher may indicate depression.

The Richard-Campbell Sleep Scale, developed by Richards in 1987, is a 6-item measure that assesses the depth of nighttime sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake after waking up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a scale ranging from 0 to 100 using the visual analog scale technique. A score between "0-25" on the scale indicates very poor sleep, while a score between "76-100" indicates very good sleep. The total scale score is evaluated based on 5 items; the 6th item, which assesses the noise level in the environment, is excluded from the total score evaluation. As the scale score increases, patients' sleep quality also improves.

Conditions

Laparoscopic Cholecystectomy Surgery

Keywords

laparoscopic cholecystectomy; respiratory physiotherapy; visual analog scale; The Richards-Campbell Sleep Questionnaire

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

4-7-8 breathe technique group

50 patients aged 18-65 with ASA I-III who will undergo laparoscopic cholecystectomy

No interventions assigned to this group

Control group

50 patients aged 18-65 with ASA I-III who will undergo laparoscopic cholecystectomy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Participants must be informed and give voluntary consent to participate in the study.

2. Patients who have undergone laparoscopic cholecystectomy.

3. Patients with an ASA physical performance score of 1-3.

4. Patients aged 18-65 years.

Exclusion Criteria

1. Patients who do not wish to continue participating in the study

2. Patients whose medical condition has deteriorated.

3. Those with a history of medication use accompanied by depression and other psychiatric diagnoses

4. Those with a history of substance dependence

5. Those with respiratory tract infection or pathology (Asthma, COPD)

6. Those with neuromuscular disorders

7. Those under the age of 18

8. Patients who cannot read or write Turkish or who are uncooperative

9. Those unable to adapt to breathing training techniques

10. Conversion from laparoscopic surgery to laparotomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Beyhekim Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sami Uyar

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya Beyhekim Research and training hospital

Konya, Konya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Facility Contacts

sami uyar, doctor

Role: primary

Other Identifiers

KonyaBeyhekimTRH2025/799

Identifier Type: -

Identifier Source: org_study_id