ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy

NCT06755970 | Completed

• 1 other identifier: AtaturkUnıversty
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Laparoscopic Cholecystectomy; Pain; ICOUGH; NAUSEA

Keywords

Pain; Laparoscopic cholecystectomy; Nausea

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  24nd hour after surgery

Study Arms (2)

Experimental: Grup 1

EXPERIMENTAL

The ICOUGH care bundle will be applied to this group.

Procedure: ICOUGH

Control grup: Grup 2

NO INTERVENTION

The ICOUGH care bundle will not be applied to this group.

Interventions

ICOUGH PROCEDURE

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.

Experimental: Grup 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Nausea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pricipal investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 1, 2025
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)