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

NCT07303634 | Not Yet Recruiting

• 1 other identifier: KonyaBeyhekimTRH2025/799
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy Surgery

Keywords

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

Outcome Measures

Primary Outcomes (3)

• visual analog scale

  A 0-10 cm scale is used, and scores are expressed on a scale of 1-10. In this case, 1-3 is generally considered mild, 4-6 moderate, and 7-10 severe.

  1th, 4th, 12th hours postoperative first day

• Hospital Anxiety and Depression Scale

  The Hospital Anxiety and Depression Scale, known as HADS, was developed specifically to screen for mental health status in individuals with physical illnesses. It consists of a total of 14 questions (items). Seven of these questions measure anxiety (HADS-A), while the other seven measure depression (HADS-D). Each question is a four-point Likert-type scale scored from 0 to 3. (Maximum 21 points). 0-7 Points: Normal 8-10 Points: Borderline case 11-21 Points: Abnormal (Case)

  12th and 24th hours postoperative first day

• Richard-Campbell Sleep Scale

  The Richard-Campbell Sleep Scale (RCSS) is a widely used subjective tool designed to assess the quality and depth of sleep, primarily in hospitalized patients, especially those in critical care units (ICU/CCU). It is typically administered immediately upon waking. The core component of the RCSS is an 100mm Visual Analog Scale (VAS) on which the patient rates the quality of their sleep from 'Worst Sleep Ever' (scored 0) to 'Best Sleep Ever' (scored 100). Higher scores indicate better self-reported sleep quality.

  12th and 24th hours postoperative first day

Secondary Outcomes (2)

• peripheral oxygen saturation

  1th, 4th, 12th and 24th hours postoperative first day

• length of hospital stay

  up to seven days

Study Arms (2)

4-7-8 breathe technique group

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

Control group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-65 who undergo laparoscopic cholecystectomy

You may qualify if:

• Participants must be informed and give voluntary consent to participate in the study.
• Patients who have undergone laparoscopic cholecystectomy.
• Patients with an ASA physical performance score of 1-3.
• Patients aged 18-65 years.

You may not qualify if:

• Patients who do not wish to continue participating in the study
• Patients whose medical condition has deteriorated.
• Those with a history of medication use accompanied by depression and other psychiatric diagnoses
• Those with a history of substance dependence
• Those with respiratory tract infection or pathology (Asthma, COPD)
• Those with neuromuscular disorders
• Those under the age of 18
• Patients who cannot read or write Turkish or who are uncooperative
• Those unable to adapt to breathing training techniques
• Conversion from laparoscopic surgery to laparotomy

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Research and training hospital

Konya, Konya, 42130, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

TU (1)