Laparoscopic CholecystectomyNCT06415890
Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy
A study testing 4-7-8 Breathing Technique in people with Laparoscopic Cholecystectomy and Breathing Exercise, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Breathing Exercise, Pulmonary Function Test
- What is being tested?
- 4-7-8 Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İskenderun Devlet Hastanesi
Hatay, 31000
Demet Çalışkan, 05458240933
About this study
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.
Read the 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
- Being tested
- 4-7-8 Breathing Technique
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 Breathing TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start25 Aug 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a prospective, two-arm randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Ayse Nur Serbest Baz, Mustafa Kemal University
- Investigators
- Gülay ALTUN UĞRAŞ, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415890
- Sponsor's protocol ID
- HMKU-SERBEST-001
- Status last verified
- Sep 2024
- First submitted
- 5 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31932939Aktas 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.
PubMed 36480101Chinagudi, 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.
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.
PubMed 35822447Toleska 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.
PubMed 35843915Lee 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.
PubMed 34954406Russo 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.
PubMed 29209423
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy
- ClinicalTrials.gov ID
- NCT06415890
- Acronym / sponsor ID
- HMKU-SERBEST-001
- Conditions
- Laparoscopic Cholecystectomy, Breathing Exercise, Pulmonary Function Test, Shoulder Pain, Surgical Nursing, 4-7-8 Breathing Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a prospective, two-arm randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Other: 4-7-8 Breathing TechniqueIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-7-8 Breathing TechniqueThe 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. | Other | Breathing Exercise Group |
Primary outcome
Shoulder Pain
Time frame: Second postoperative day
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)
Pulmonary Function Test
Time frame: Second postoperative day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31932939Hosseinzadeh 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.
- Background: PubMed 36480101Aktas 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.
- BackgroundChinagudi, 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: PubMed 35822447Vierra 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.
- Background: PubMed 35843915Toleska 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.
- Background: PubMed 34954406Lee 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.
- Background: PubMed 29209423Russo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay ALTUN UĞRAŞ study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 Breathing Technique in people with Laparoscopic Cholecystectomy and Breathing Exercise, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Nur SERBEST BAZ (03262213317, aysenurserbest@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: Second postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415890, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.