ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy (ICOUGHBundle)

February 12, 2025 updated by: MERVE KAYA, Ataturk University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Grup 1
The ICOUGH care bundle will be applied to this group.
Procedure: ICOUGH

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 48 hours.

Postoperative pain and nausea will be assessed with the help of data collectors, using a numerical rating scale at 2, 4, 8, 12, 24, and 48 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.
No Intervention: Control grup: Grup 2
The ICOUGH care bundle will not be applied to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2nd hour after surgery
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.
4nd hour after surgery
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.
8nd hour after surgery
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.
12nd hour after surgery
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.
24nd hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtaturkUnıversty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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