Laparoscopic CholecystectomyICOUGHBundleNCT06755970
ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy
A study testing ICOUGH in people with Laparoscopic Cholecystectomy and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study will use a randomized controlled experimental research design. The population of the study will consist of all adult patients who undergo laparoscopic cholecystectomy at the General Surgery Clinic of Atatürk University Research Hospital between December 2024 and September 2025. 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, Pain, ICOUGH
- What is being tested?
- ICOUGH
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Oct 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
- Those who agree to participate in the study and volunteer
- Aged 18 and above
- Undergoing laparoscopic cholecystectomy surgery under general anesthesia
- Those without physical or mental disabilities, limitations, or conditions that would prevent them from performing respiratory exercises (such as the use of medications affecting respiration, conditions requiring oxygen therapy, etc.)
- Those whose cognitive level is suitable for the application of scales
- Patients without communication problems will be included in the study
Who cannot join
- Those whose hemodynamic values are not stable after the surgical intervention
- Those who develop any complications such as severe bleeding, nausea, vomiting, etc., after surgery
- Patients with acute or chronic lung diseases
- Patients who voluntarily wish to withdraw from the study will not be included in the study
- Required postoperative mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the ICOUGH Bundle Applied Under Nurse Leadership on Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Study
This study will use a randomized controlled experimental research design. The population of the study will consist of all adult patients who undergo laparoscopic cholecystectomy at the General Surgery Clinic of Atatürk University Research Hospital between December 2024 and September 2025. The data will be collected using a Descriptive Information Form and the Visual Analogue Scale. The research has received institutional approval and ethics committee approval. The study will be conducted with collaboration from healthcare professionals in the clinic after they have been informed. Patients who meet the inclusion criteria will be invited to participate in the study after being approached one day before surgery. Oral and written consent will be obtained from those who volunteer and agree to participate. The data will be analyzed using SPSS for Windows 22 software.
Read the detailed description
Post-laparoscopic cholecystectomy, patients may experience pain at the incision site, internal organ pain, and shoulder pain. Shoulder pain occurs due to the irritation of the diaphragm peritoneum by dissolved CO2 gas, causing the diaphragm to stretch, which stimulates the phrenic nerve and results in shoulder pain in these patients. This shoulder pain is typically felt up to 72 hours or three days after surgery.
Shoulder pain in these patients is typically felt for up to 72 hours or three days after surgery. Pneumoperitoneum during laparoscopy can also produce vagal stimulation, which can lead to nausea and vomiting. In this context, the removal of CO2 is essential for managing post-laparoscopic cholecystectomy CO2-related pain.
Given the relatively common and costly occurrence of postoperative respiratory complications, various protocols have been used to reduce the risk of these complications. One such protocol is the ICOUGH (Incentive spirometry, Coughing and deep breathing, Oral care, Patient understanding of the interventions, Getting out of bed and Head of bed elevation) bundle, developed by the Boston University School of Medicine in 2012 to reduce postoperative respiratory complications. This respiratory care bundle improves oxygenation and CO2 elimination, thus increasing the patient's recovery rate, reducing the amount of analgesics used, and shortening the time to return to daily activities.
The ICOUGH bundle, which is among the important independent responsibilities of perioperative nurses, helps reduce shoulder pain and accelerate postoperative recovery by increasing CO2 elimination and oxygenation. The use of non-pharmacological methods for pain relief in the postoperative period strengthens the nurse's role in pain management. The aim of this study is to determine the effects of the ICOUGH bundle on shoulder pain, abdominal pain, and nausea after laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy, Pain, ICOUGH, NAUSEA
- Being tested
- ICOUGH
- Keywords
- Pain, Laparoscopic cholecystectomy, Nausea
- Medical subject headings
- Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOUGHProcedure or surgery
After the patient has recovered from postoperative anesthesia and their hemodynamic values have stabilized, the ICOUGH bundle applications mentioned above will be carried out. The patient's pain and nausea levels will be recorded for a period of 24 hours.
Postoperative pain and nausea will be assessed with the help of data collectors, using a numerical rating scale at 2, 4, 8, 12 and 24 hours after surgery.
Considering that postoperative respiratory complications are relatively common and costly, various studies have been conducted to explore ways to reduce the risk of their occurrence. One of these protocols is the ICOUGH bundle, which stands for Incentive Spirometry, Coughing and Deep Breathing, Oral Care, Patient Understanding of the Interventions, Getting Out of Bed, and Head of Bed Elevation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Grup 1 | Experimental | The ICOUGH care bundle will be applied to this group. Receives: Procedure: ICOUGH |
| Control grup: Grup 2 | No intervention | The ICOUGH care bundle will not be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Measured: 2nd hour after surgery
Visual Analog Scale (VAS)
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Measured: 4nd hour after surgery
Visual Analog Scale (VAS)
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Measured: 8nd hour after surgery
Visual Analog Scale (VAS)
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Measured: 12nd hour after surgery
Visual Analog Scale (VAS)
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Measured: 24nd hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KAYA, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755970
- Sponsor's protocol ID
- AtaturkUnıversty
- Acronym
- ICOUGHBundle
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the ICOUGH Bundle Applied Under Nurse Leadership on Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06755970
- Acronym / sponsor ID
- ICOUGHBundle / AtaturkUnıversty
- Conditions
- Laparoscopic Cholecystectomy, Pain, ICOUGH, NAUSEA
- Keywords
- Pain, Laparoscopic cholecystectomy, Nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 1 Jan 2025 (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 will use a randomized controlled experimental research design. The population of the study will consist of all adult patients who undergo laparoscopic cholecystectomy at the General Surgery Clinic of Atatürk University Research Hospital between December 2024 and September 2025. The data will be collected using a Descriptive Information Form and the Visual Analogue Scale. The research has received institutional approval and ethics committee approval. The study will be conducted with collaboration from healthcare professionals in the clinic after they have been informed. Patients who meet the inclusion criteria will be invited to participate in the study after being approached one day before surgery. Oral and written consent will be obtained from those who volunteer and agree to participate. The data will be analyzed using SPSS for Windows 22 software.
Detailed description
Post-laparoscopic cholecystectomy, patients may experience pain at the incision site, internal organ pain, and shoulder pain. Shoulder pain occurs due to the irritation of the diaphragm peritoneum by dissolved CO2 gas, causing the diaphragm to stretch, which stimulates the phrenic nerve and results in shoulder pain in these patients. This shoulder pain is typically felt up to 72 hours or three days after surgery.
Shoulder pain in these patients is typically felt for up to 72 hours or three days after surgery. Pneumoperitoneum during laparoscopy can also produce vagal stimulation, which can lead to nausea and vomiting. In this context, the removal of CO2 is essential for managing post-laparoscopic cholecystectomy CO2-related pain.
Given the relatively common and costly occurrence of postoperative respiratory complications, various protocols have been used to reduce the risk of these complications. One such protocol is the ICOUGH (Incentive spirometry, Coughing and deep breathing, Oral care, Patient understanding of the interventions, Getting out of bed and Head of bed elevation) bundle, developed by the Boston University School of Medicine in 2012 to reduce postoperative respiratory complications. This respiratory care bundle improves oxygenation and CO2 elimination, thus increasing the patient's recovery rate, reducing the amount of analgesics used, and shortening the time to return to daily activities.
The ICOUGH bundle, which is among the important independent responsibilities of perioperative nurses, helps reduce shoulder pain and accelerate postoperative recovery by increasing CO2 elimination and oxygenation. The use of non-pharmacological methods for pain relief in the postoperative period strengthens the nurse's role in pain management. The aim of this study is to determine the effects of the ICOUGH bundle on shoulder pain, abdominal pain, and nausea after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Grup 1 | Experimental | Procedure: ICOUGHThe ICOUGH care bundle will be applied to this group. |
| Control grup: Grup 2 | No intervention | –The ICOUGH care bundle will not be applied to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who agree to participate in the study and volunteer
- Aged 18 and above
- Undergoing laparoscopic cholecystectomy surgery under general anesthesia
- Those without physical or mental disabilities, limitations, or conditions that would prevent them from performing respiratory exercises (such as the use of medications affecting respiration, conditions requiring oxygen therapy, etc.)
- Those whose cognitive level is suitable for the application of scales
Key exclusion criteria (5 listed)
- Those whose hemodynamic values are not stable after the surgical intervention
- Those who develop any complications such as severe bleeding, nausea, vomiting, etc., after surgery
- Patients with acute or chronic lung diseases
- Patients who voluntarily wish to withdraw from the study will not be included in the study
- Required postoperative mechanical ventilation
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 |
|---|---|---|
| ICOUGHAfter the patient has recovered from postoperative anesthesia and their hemodynamic values have stabilized, the ICOUGH bundle applications mentioned above will be carried out. The patient's pain and nausea levels will be recorded for a period of 24 hours. Postoperative pain and nausea will be assessed with the help of data collectors, using a numerical rating scale at 2, 4, 8, 12 and 24 hours after surgery. Considering that postoperative respiratory complications are relatively common and costly, various studies have been conducted to explore ways to reduce the risk of their occurrence. One of these protocols is the ICOUGH bundle, which stands for Incentive Spirometry, Coughing and Deep Breathing, Oral Care, Patient Understanding of the Interventions, Getting Out of Bed, and Head of Bed Elevation. | Procedure or surgery | Experimental: Grup 1 |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 2nd hour after surgery
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Visual Analog Scale (VAS)
Time frame: 4nd hour after surgery
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Visual Analog Scale (VAS)
Time frame: 8nd hour after surgery
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Visual Analog Scale (VAS)
Time frame: 12nd hour after surgery
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Visual Analog Scale (VAS)
Time frame: 24nd hour after surgery
Patients are asked to rate their pain level on a horizontal line between 0 and 10. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, it is used as the most suitable tool to assess pain intensity. It can be used to evaluate both pain and nausea.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICOUGH in people with Laparoscopic Cholecystectomy and Pain, run by Ataturk 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 2nd hour after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.