Laparoscopic CholecystectomyNCT07029477
Incentive Spirometry Versus Massage Therapy Among Post Laparoscopic Cholecystectomy Patients
A study testing Incentive Spirometry and Massage Therapy in people with Laparoscopic Cholecystectomy and Shoulder Pain, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Shoulder Pain, Nausea
- What is being tested?
- Incentive Spirometry and Massage Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Nov 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sexes.
- Patients aged between 20 to 60 years.
- Patients having the ability to communicate.
- Willing to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Nursing. Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Incentive Spirometry Versus Massage Therapy on the Level of Shoulder Pain and Nausea Among Post Laparoscopic Cholecystectomy Patients
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.
- Conditions
- Laparoscopic Cholecystectomy, Shoulder Pain, Nausea
- Being tested
- Incentive Spirometry, Massage Therapy
- Medical subject headings
- Shoulder Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometryDevice
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.
Massage TherapyBehavioural
Participants received manual massage therapy at regular intervals of 4, 8, and 12 hours after laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry for Postoperative Pain and Nausea | Experimental | Participants in this group received incentive spirometry therapy only. Receives: Device: Incentive Spirometry |
| Massage Therapy for Postoperative Pain and Nausea | Experimental | Participants in this group received massage therapy only. Receives: Behavioral: Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours post laparoscopic cholecystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
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 Mansoura 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi-experimental research design
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Arafat Ali Mohamed, Mansoura University
- Investigators
- Amal Eid Abdel Moneim, Assist Professor, Study director, Mansoura UniversityWafaa Ismail Shereif, Professor, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029477
- Sponsor's protocol ID
- Spirometry Versus Massage
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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."
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometry Versus Massage Therapy on the Level of Shoulder Pain and Nausea Among Post Laparoscopic Cholecystectomy Patients
- ClinicalTrials.gov ID
- NCT07029477
- Acronym / sponsor ID
- Spirometry Versus Massage
- Conditions
- Laparoscopic Cholecystectomy, Shoulder Pain, Nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Jun 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental research design
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry for Postoperative Pain and Nausea | Experimental | Device: Incentive SpirometryParticipants in this group received incentive spirometry therapy only. |
| Massage Therapy for Postoperative Pain and Nausea | Experimental | Behavioral: Massage TherapyParticipants in this group received massage therapy only. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sexes.
- Patients aged between 20 to 60 years.
- Patients having the ability to communicate.
- Willing to participate in the study.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Incentive SpirometryParticipants 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. | Device | Incentive Spirometry for Postoperative Pain and Nausea |
| Massage TherapyParticipants received manual massage therapy at regular intervals of 4, 8, and 12 hours after laparoscopic cholecystectomy. | Behavioural | Massage Therapy for Postoperative Pain and Nausea |
Primary outcome
Shoulder Pain Level & Nausea
Time frame: Within 12 hours post laparoscopic cholecystectomy
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.
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 19 Jun 2025.
- Individual participant dataSharing planned: 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."
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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.
Amal Eid Abdel Moneim, Assist Professor study director
Mansoura University
Wafaa Ismail Shereif, Professor study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry and Massage Therapy in people with Laparoscopic Cholecystectomy and Shoulder Pain, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 8 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 19 Jun 2025. 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 Egypt. 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?
Shoulder Pain Level & Nausea (time frame: Within 12 hours post laparoscopic cholecystectomy). 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 19 Jun 2025.