Shoulder Pain Clinical Trial
Official title:
The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy
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.
Status | Not yet recruiting |
Enrollment | 98 |
Est. completion date | July 15, 2025 |
Est. primary completion date | April 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Mustafa Kemal University | Mersin University |
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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