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

NCT06415890 | Recruiting

• 1 other identifier: HMKU-SERBEST-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain

  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)

  Second postoperative day

• Pulmonary Function Test

  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.

  Second postoperative day

Study Arms (2)

Breathing Exercise Group

EXPERIMENTAL

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.

Other: 4-7-8 Breathing Technique

Control Group

NO INTERVENTION

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.

Interventions

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.

Breathing Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mustafa Kemal University: lead
• Mersin University: collaborator

Study Sites (1)

İskenderun Devlet Hastanesi

Hatay, 31000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Hosseinzadeh F, Nasiri E, Behroozi T. Investigating the effects of drainage by hemovac drain on shoulder pain after female laparoscopic surgery and comparison with deep breathing technique: a randomized clinical trial study. Surg Endosc. 2020 Dec;34(12):5439-5446. doi: 10.1007/s00464-019-07339-z. Epub 2020 Jan 13.

  PMID: 31932939 BACKGROUND

• Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.

  PMID: 36480101 BACKGROUND

• Chinagudi, S., Badami, S., Herur, A., Patil, S., Gv, S., & Ankad, R. (2014). Immediate effect of short duration of slow deep breath-ing on heart rate variability in healthy adults. National Journal of Physiology, Pharmacy and Pharmacology, 4(3), 233- 235.

  BACKGROUND

• Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.

  PMID: 35822447 BACKGROUND

• Toleska M, Dimitrovski A, Shosholcheva M, Kartalov A, Kuzmanovska B, Dimitrovska NT. Pain and Multimodal Analgesia in Laparoscopic Cholecystectomy. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2022 Jul 13;43(2):41-49. doi: 10.2478/prilozi-2022-0017.

  PMID: 35843915 BACKGROUND

• Lee J, Hur MH. The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2022 Feb;16(1):1-8. doi: 10.1016/j.anr.2021.11.002. Epub 2021 Dec 24.

  PMID: 34954406 BACKGROUND

• Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.

  PMID: 29209423 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülay ALTUN UĞRAŞ

  Mersin University

  STUDY DIRECTOR

Central Study Contacts

Ayşe Nur SERBEST BAZ

CONTACT

03262213317; aysenurserbest@hotmail.com

Gülay ALTUN UĞRAŞ

CONTACT

03243610001; gulaltun@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The information that the patients included in the research sample were assigned to groups A and B according to the randomization table will be kept by the consultant, the researcher will fill out the "Informed Consent Form" for all patients when he/she goes to the patient for the application, and then the consultant will share the information about which group the patient is in with the researcher. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The study was planned as a prospective, two-arm randomized controlled clinical trial.

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 16, 2024
• Study Start: August 25, 2024
• Primary Completion: April 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)