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CompletedNCT07029477Updated Jun 19, 2025

Incentive Spirometry Versus Massage Therapy Among Post Laparoscopic Cholecystectomy Patients

An interventional study of Incentive Spirometry and Massage Therapy in Laparoscopic Cholecystectomy, Shoulder Pain and Nausea, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Apr 2024, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

The aim of this study is to:

Evaluate the effect of incentive spirometry versus massage therapy on the level of shoulder pain, and nausea among post laparoscopic cholecystectomy patients.

Read the detailed description

Acute cholecystitis is an inflammation of the gallbladder usually caused by gallstones obstructing the gallbladder neck or cystic duct. It is one of the most common surgical emergency presentations globally. Cholecystectomy was well-known as the surgical care for cholecystitis and the preferred treatment for gallstone disease. Earlier, open cholecystectomy was the gold standard for treatment of cholecystitis. However, open cholecystectomy has been associated with a higher risk of surgical site infection (SSI).

Owing to open surgical procedures complications, the laparoscopic technique has now replaced the open technique in many common surgical procedures, including routine cholecystectomy. Laparoscopic cholecystectomy (LC) is clearly defined as a minimally invasive surgical procedure to remove an inflamed gallbladder resulting from symptomatic cholelithiasis, gallstone, gallbladder masses, or polyps.

Laparoscopic cholecystectomy not only benefits the patient by reducing postoperative pain, discomfort, reducing intraabdominal adhesions, improving cosmetic results, shortening hospital stay, and quickening return to usual activities, but it also benefits the surgeon by improving vision and access to the Calot's triangle. In spite of several blessings of laparoscopic surgical treatment, shoulder pain is considered one of early post laparoscopic symptoms. It seems to have a multifactorial mechanism, but the most reported theory is carbon dioxide gas persistence between the right diaphragm and the hepatic dome that stays inside the abdominal cavity for some times. The surgeon injects CO2 gas into the peritoneum to increase the field of vision dur¬ing cholecystectomy via laparoscopy, this gas causes stretching of the peritoneum and diaphragm, as well as excitation of the phrenic nerve and creation of shoulder pain.

In other words, pain occurs in the scapula through stimulating the phrenic nerve, which originates from the third and fifth cervical nerves (C3-C5) and controls movement and provides sensation in the diaphragm. Postoperative pain can lead to increase heart rate, high blood pressure, and consequently, increase cardiac workload, nausea, vomiting, and ileus.

During laparoscopy, the pneu¬moperitoneum can irritate the vagus nerve, leading to post-operative nausea and vomiting (PONV) which cause delayed discharge, dehydration, wound opening, pulmonary aspiration, patient dissatisfaction, and increased treatment costs. Approximately (50-75%)of patients develop PONV. Prevention and treatment of postoperative pain and control of complications such as nausea and vomiting play an important role in early mobility, improve the quality of surgery, and lead to patient satisfaction, early discharge, and reduce costs.

Pharmacological and non-pharmacological applications are widely used to improve the quality of recovery after laparoscopic cholecystectomy. Pain killers as opioids and nonsteroidal anti-inflammatory drugs have side effects such as respiratory depression, nausea, itching, and bleeding which may affect patient's recovery. Various drugs such as dopamine antagonists, and Dimenhydrinate are used for the prevention and treatment of nausea and vomiting, but each has advantages and disadvantages.

Non-pharmacological nursing measures are cost effective, reduce pain, and analgesic drug dosage, improve patient's emotional control, and increase their functional capability. Variant studies show that shoulder pain is less if the initial pressure of CO2 is maintained below normal levels. With the same approach, chest physiotherapy may have an impact on the mechanical movement of the chest wall and diaphragm. Multiple studies shows and report the dynamic movements of diaphragm and chest wall by cine magnetic resonance image, by stretching the alveoli and chest, the diaphragm's movements increase and contract downward. As a result, less CO2 is accumulated inside the abdominal cavity and result in the removal of CO2.

In this respect, it is essential for surgical nurses to provide education on the proper usage of incentive spirometry to patients, as well as explain its significance and the positive impact of regular intervals on the recovery process. However, studies have found that the rates of teaching and applying deep breathing technique to patients via incentive spirometry are not at the desired level.

Therapeutic massage is also one of the non-pharmacological interventions, it's the manipulation of the soft tissue of whole body areas to bring about generalized improvements in health. It is a non-invasive method with an easy application used to increase the quality of surgery.

The effect of massage on pain is explained with the Gate Control Theory of Melzack. According to this theory, when massage is applied, the A-alpha and A-beta thick tactile fibers moving faster than the A-delta and C fine fibers that are involved in the transmission of the pain, prevent the impulses in the small-diameter fibers that carry the pain from reaching upper levels. The mechanoreceptors that are located in the center of the tactile fibers, which are mentioned in this theory, are found in the hands and feet.

Hand massage has been studied as a potential intervention to reduce postoperative nausea after laparoscopic cholecystectomy. Therefore, the purpose of this study is to evaluate the effect of incentive spirometry versus massage therapy on post laparoscopic cholecystectomy patients in terms of their level of shoulder pain, and nausea.

02

Conditions studied

  • Laparoscopic Cholecystectomy
  • Shoulder Pain
  • Nausea
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 96 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Both sexes.
  • Patients aged between 20 to 60 years.
  • Patients having the ability to communicate.
  • Willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients who had postoperative bleeding.
  • Patients who had postoperative hemodynamic disorders (severe elevation or reduction of blood pressure and shock).
  • Patients who had postoperative complications requiring mechanical ventilation.
  • Patients who had respiratory aspiration.
  • Patients who had a history of drug abuse.
  • Patients who had previous shoulder pain chronicity
  • Uncooperative patients or patients unable to understand how to use the incentive spirometry device properly.
  • Patients whose surgery converted from laparoscopic to open surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Incentive Spirometry for Postoperative Pain and Nausea

    Participants in this group received incentive spirometry therapy only.

    Device: Incentive Spirometry

  • Experimental
    Massage Therapy for Postoperative Pain and Nausea

    Participants in this group received massage therapy only.

    Behavioral: Massage Therapy

Interventions

  • DeviceIncentive Spirometry

    Participants received incentive spirometry therapy using a standard device beginning within 2 hours post-laparoscopic cholecystectomy. They were instructed to take 10 deep breaths every 2 hours for 12 hours.

  • BehavioralMassage Therapy

    Participants received manual massage therapy at regular intervals of 4, 8, and 12 hours after laparoscopic cholecystectomy.

06

What researchers measure

Primary outcomes

  1. Shoulder Pain Level & Nausea

    Change in patient-reported shoulder pain and nausea using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain or nausea and 10 indicates the worst possible pain or nausea. Higher scores indicate worse outcomes.

    Time frame: Within 12 hours post laparoscopic cholecystectomy

07

Study locations

1 site
  • Faculty of Nursing. Mansoura University
    Mansoura, Dakahlia 35516, Egypt
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 29, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — "Due to the strict confidentiality agreements with participants, individual participant data (IPD) will not be shared. Protecting participant privacy and complying with ethical standards are our top priorities."

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07029477
Lead sponsor
Mansoura University
Responsible party
Sara Arafat Ali Mohamed (Dr, Mansoura University) — Principal investigator
First posted
Jun 19, 2025
Start date
Apr 1, 2024
Primary completion
Nov 1, 2024
Completion
Nov 30, 2024
Last update
Jun 19, 2025

Study contacts

Amal Eid Abdel Moneim, Assist Professor
study director · Mansoura University
Wafaa Ismail Shereif, Professor
study director · Mansoura University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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