ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ICOUGH
Procedure/SurgeryAfter 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental: Grup 1Experimental treatment 1 intervention
Group B: Control grup: Grup 2No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
2nd hour after surgery2
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.
Time frame
4nd hour after surgery3
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.
Time frame
8nd hour after surgery4
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.
Time frame
12nd hour after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: