Incentive Spirometry Versus Massage Therapy on the Level of Shoulder Pain and Nausea Among Post Laparoscopic Cholecystectomy Patients
Phase: NA
Conditions: Laparoscopic Cholecystectomy, Shoulder Pain, Nausea
Sponsor: Mansoura University

 
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Official Title of the study: 
Incentive Spirometry Versus Massage Therapy on the Level of Shoulder 
Pain and Nausea among Post Laparoscopic Cholecystectomy Patients 
NCT number: 
NCT number not yet assigned 
Principal Investigator: 
Sara Arafat Ali Mohamed 
Assistant lecturer of Medical Surgical Nursing Department 
Faculty of Nursing–Mansoura University 
Date of Document: 
 
October 29, 2023 
 
 
 
 
 
 
 

 
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Incentive Spirometry Versus Massage Therapy on the Level of Shoulder 
Pain and Nausea among Post Laparoscopic Cholecystectomy Patients 
Acute cholecystitis is an inflammation of the gallbladder usually caused by 
gallstones obstructing the gallbladder neck or cystic duct (Adachi, Eguchi, & Muto, 
2022).  It is one of the most common surgical emergency presentations globally 
(Cirocchi et al., 2023).  Cholecystectomy was well-known as the surgical care for 
cholecystitis and the preferred treatment for gallstone disease (Salem, Salah, Abdel-
Hady & Abdallah, 2023).  Earlier, open cholecystectomy was the gold standard for 
treatment of cholecystitis (Samee, Abaidullah, Afzal, Qammar, Iqbal, & Sharif, 2023).  
However, open cholecystectomy has been associated with a higher risk of surgical site 
infection (SSI) (Subhan, Riaz, Iqbal, Malik, Ali, & Shaikh, 2022). 
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 
(Mohammed, Rajab & Naif, 2023).   
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 
(Singh, & Kaur, 2023).  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 

 
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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 during 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 (Bastamizad, Abbasi, Salari, & Jalali, 
2023). 
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 (Imani, Nejati, Sepidkar, & 
Talebi-Ghane, 2023). Postoperative pain can lead to increase heart rate, high blood 
pressure, and consequently, increase cardiac workload, nausea, vomiting, and ileus 
(Sane, Sayyadi, Abbasivash, Rezaei, Azadfar, & Salimi, 2023).   
During laparoscopy, the pneumoperitoneum 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 
(Mohammed et al., 2023).  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 (Seyedsadeghi, Arabzadeh, Entezariasl, Shahbazzadegan, Dindar, & 
Isazadehfar, 2023).   
Pharmacological and non-pharmacological applications are widely used to 
improve the quality of recovery after laparoscopic cholecystectomy (Mottahedi, 
Shamsi, Babani, Goli, & Rizevandi, 2023).  Pain killers as opioids and nonsteroidal 
anti-inflammatory drugs have side effects such as respiratory depression, nausea, 

 
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itching, and bleeding which may affect patient's recovery (Weng, Cheng, & Li, 2023). 
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 (Adibi, 2023).   
Non-pharmacological nursing measures are cost effective, reduce pain, and 
analgesic drug dosage, improve patient's emotional control, and increase their 
functional capability (Hassan, Fathy, Mohamed, Ibrahim, & Hassan, 2023).  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 (Bakr, Ayad, 
Abdelraouf, & Abosayed, 2023).  
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 (Bulut & Karabulut, 2023). 
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 (Mottahedi et al., 2023).  

 
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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 (Sözen, & Karabulut, 2020). 
Hand massage has been studied as a potential intervention to reduce 
postoperative nausea after laparoscopic cholecystectomy (Yaghoubinia, Abbasnia, & 
Zakerimoghadam, 2019). 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.  
 
 
 
 
 
 
 
 
 
 

 
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Significance of the study 
Cholecystitis is a common digestive health problem.  Thousands of people 
develop symptoms of acute cholecystitis annually across the world (Fouad, Rezk, 
Saber, Khalifa, Ibraheim, & Ibraheim, 2022).  It affects 1–4% of the western world  
population per year.  Recently, cholecystectomy is the most common intra-abdominal  
operative interventions and was estimated to be about 500,000 annually in the USA 
(Doush, Abdelaziz, & Musaad, 2023).  In the Middle East cholecystectomy is one of 
the most common operation performed in general surgical units. It represents up to 
57% of major elective surgery and about 43% of emergency surgery (Farahat, Soltan, 
Shaheen, Hegazy, & Elghalban, 2021).  
Laparoscopic cholecystectomy (LC) is one of the most commonly performed 
general surgical procedures worldwide, especially in Arab countries (Ali, Kadhim, & 
Khachian, 2023).  While LC continues to evolve, postoperative pain remains a 
significant concern.  Shoulder pain is among the early symptoms experienced after LC 
(Saremirad, Yazdimoghaddam, Dalili, & Rastaghi, 2022).  Shoulder pain and 
discomfort can lead to a decrease in patient satisfaction ranging from 35% to 80% and 
may also result in prolonged hospital stays, increase healthcare costs, and a higher risk 
of complications (Park, 2020).  Approximately 50-75% of patients develop a 
postoperative nausea and vomiting, with a resulting high management cost, delayed 
discharge and patient dissatisfaction  (Mohammed et al., 2023). 
 
 
 

 
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Aim of the study 
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.  
Research hypotheses: 
 H1: patients undergoing laparoscopic cholecystectomy surgery who utilize 
incentive spirometry or receive massage therapy will experience less shoulder pain, 
and nausea compared to those who receive routine care.   
 H2: patients undergoing laparoscopic cholecystectomy surgery and utilize incentive 
spirometry will experience less shoulder pain, and nausea compared to those who 
receive massage therapy 
 H3: patients undergoing laparoscopic cholecystectomy surgery who receive 
massage therapy will experience less shoulder pain, and nausea compared to those 
who utilize incentive spirometry.  
Operational definition: 
 An incentive spirometry:  is a medical device that facilitate sustained, maximal 
inspiration (SMI) with incorporated visual indicators of performance. The device 
typically consists of a plastic chamber with a measurement indicator and a 
mouthpiece.  The patient inhales through the mouthpiece, creating a flow of air that 
raises the measurement indicator.  The technique involves taking 10 deep breaths 
every 2 hours for 12 hours.  Specifically, the patient assumes a sitting position or 
half-sitting position, places the spirometry tube inside the mouth, inhales, holds his 

 
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breath for 3 seconds, and then exhales slowly through the mouth while removing 
the device (Zerang, Amouzeshi, & Barkhordari-Sharifabad, 2022). 
 Massage Therapy, refers to specific massage techniques which include Kneading-
Friction-Petrissage techniques. These techniques involve manipulating the muscles 
and soft tissues in specific ways.  Petrissage Massage, applying direct pressure 
slowly and rhythmically with the fingertips.  Friction Massage, rubbing in small 
areas in a circle while pressing the area with the front of the fingertips or the front 
of the palm.  Kneading Massage, is similar to twisting and changes the 
compression direction in succession (Mottahedi et al., 2023).  
 
 
 
 
 
 
 
 
 

 
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Method 
Study Design:  
A quasi-experimental research design will be utilized to carry out this study.  It 
is a suitable design which attempts to compare three groups by applying interventions 
to two groups and comparing with a control group (Polit & Beck, 2020). 
Setting: 
 
 
This study will be conducted in the Gastrointestinal Surgery Center, at 
Mansoura University.  Where patients undergo laparoscopic cholecystectomy.   
Subjects: 
Sample technique: 
A purposive sample of 96 patients undergoing laparoscopic cholecystectomy 
surgery, experiencing shoulder pain and nausea, the study participants will be divided 
into three matched groups: Incentive spirometry group (A) , Massage therapy group 
(B)and control group (C) in the above-mentioned settings and fulfilling the following 
criteria: 
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:  
 Patients who had postoperative bleeding.  

 
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 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 
Sample size calculation: 
 The sample size was calculated using research software (https://clincalc.com) 
based on a previous study done by (Bastamizad et al., 2023), that noticed a 
pronounced improvement in the intervention groups in the three measurements by 
mean± SD, of (4.5 ± 1.3, 3.5 ± 1.2, and 2.55 ± 1.2) and (4.5 ± 1.4, 3.6 ± 1.3, and 2.4 ± 
1.3) compared to (4.7 ± 1.2, 4 ± 1.4, and 3.6 ± 1.3) in the control group. At Power (1-β 
error probability) = 0.80 and α error probability = 0.05. So, final sample size is 96 (32 
patients in each group). 
 
Formula of calculating sample size 

 
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Tools of data collection: 
Two tools will be used to collect data pertinent to the study: 
Tool I: A structured Interview Questionnaire: 
This tool will be developed by the researcher after reviewing relevant 
literature.  It will include the following 2 part: 
Part 1: Patient's Demographic Data: 
This part will be used to address the personal data of the patients; it will 
include the patient's age, gender,  marital status, level of education, occupation,…..  
Part 2: Health Relevant Data: 
This part will focus on the patient's medical history, history of previous 
surgery, vital signs, smoking,  weight, height, body mass index, total length of stay…..   
Tool II: visual analog scale (VAS): 
 
To investigate the severity of shoulder pain and level of nausea experienced 
by the patient. Patients are able to self-report their level of pain and nausea using this 
scale. The severity of pain and nausea will be recorded four times by the participants 
(before the intervention as well 4, 8 and 12 hours following the intervention). This 
instrument will be provided to the patient to mark a point on the line that best 
represents their level of shoulder pain and nausea experienced. They will be asked to 
assign a separate score for the sensation of shoulder pain as well as for the level of 
nausea.  Then, based on the stated number, the severity of pain and nausea will be 
documented. 
 

 
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Scoring system: 
- For measuring the intensity of pain adopted from (Ghai et al. 2015).  The VAS 
instrument is a 10-cm ruler on which one side shows "no pain = 0" and other side 
shows " worst possible pain= 10". Its total score ranges from 0 to 10 where: 
- 
Score (0) = No pain                                               
- 
Score (1-3) = Mild 
- 
Score (4-6) = Moderate                                         
- 
Score (7-10) = Severe pain. 
- For measuring the level of nausea adopted from (Boogaerts, Vanacker, Seidel, 
Albert, & Bardiau, 2000). The VAS instrument is a 10-cm ruler on which one side 
shows "no nausea = 0" and other side shows " severe nausea = 10". Its total score 
ranges from 0 to 10 where: 
- 
Score (0) = No nausea 
- 
Score (1-3) = Mild 
- 
Score (4-6) = Moderate                                         
- 
Score (7-10) = Severe nausea. 
Data collection process: 
Phase I: The Preparatory phase: 
- Administrative stage:  
 
An Ethical approval will be obtained from the Research Scientific Ethical 
Committee of the Faculty of Nursing, Mansoura University. 
 
An official letter to carry out the study will be submitted from the faculty of 
Nursing, Mansoura University to the director of the Gastrointestinal Surgery 
Center, at Mansoura University.  

 
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 
An official written permission to carry out the study will be obtained from the 
director of Gastrointestinal Surgery Center, at Mansoura University, to obtain his 
approval to conduct the study after an explanation of the purpose of the study. 
 
The researcher will meet the head nurse of the Gastrointestinal Surgery Center and 
the coordination of the study process will be conducted among nursing staff.  
- Tools development: 
 
Tool I: A structured Interview Questionnaire: (Patient's demographic data and 
health-relevant data) will be developed by the researcher based on a review of 
related literature.  
- Validity of the study tools: 
 
Content validity of the study tools will be assessed and revised by a panel of five 
experts in the field of Medical-Surgical Nursing. It will be revised for its clarity, 
content, a sequence of items and relevance or irrelevance of content to measure the 
extent to which the scores represent the variables they intended to measure. 
suggestion of the jury members will be followed. 
- Reliability of the study tools: 
 
It will be measured to evaluate whether all items on the study tools measure the 
same variable over time and how well the study items fit together conceptually.  
The internal consistency of the study tools will be tested by means of the 
Cronbach's alpha coefficient test. 
- Training course: 
 
The researcher will undergo a training course on how to perform kneading-friction-
petrissage correctly in order to ensure effective technique. 
 

 
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Phase II: The Operational phase: 
- pilot study: 
 
A pilot study will be carried out on 10% of the study sample (10) to ensure the 
feasibility, clarity, relevance, comprehensiveness, free of mistakes and applicability 
of the study tools, to allow necessary adjustment before conducting large scale 
study, to estimate the time needed to fill the questionnaire sheet.  It will be 
excluded from the study sample. 
- Filed work:  
 
The researcher will start by introducing herself to the patients and giving them a 
brief idea about the aim of the study. 
 
The  framework of the study will be carried out in four stages, that will start from 
the postoperative phase, consciousness recovery, and ultimately reaching a point 
where patients are capable of responding to nursing instructions as the following: 
1. Assessment phase; using all study tools to ensure that all patients fulfill 
the inclusion criteria  
2. Planning phase; Based on the findings of assessment phase, patients who 
match sampling criteria & who accept to participate in the study will be 
divided into three equal groups, the incentive spirometry group (A) for 
which a spirometry device will be utilized, the massage therapy group (B) 
for which a kneading-friction-petrissage technique will be performed and 
control group (C) who will receive hospital routine care  
3. Implementation phase; Patients in the incentive spirometry group (A) will 
be instructed in a clear and simplified manner on how to use the incentive 
spirometer correctly. This includes understanding the purpose of the 

 
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technique and the proper technique for effective use which involve taking 
10 deep breath via the incentive spirometry every 2 hours for 12 hours. 
And  next, patients will be asked to redemonstrate the usage of the 
spirometry, so that the researcher could confirm correct application of the 
training; patients in the massage therapy group (B), kneading-friction-
petrissage technique will be explained in a clear and simplified manner, 
taking into consideration their health condition, the massage will be 
performed at regular intervals of 4, 8, and 12 hour after the surgery; 
patients in the control group (C); will receive only the hospital routine 
care. 
4. Evaluation phase: This phase aims to evaluate the effect of an incentive 
spirometry versus massage therapy on the level of shoulder pain, and 
nausea at 4, 8 and 12 hours following the intervention in the two 
experimental groups  and comparing with the control group   
Ethical consideration and human rights: 
All relevant possible aspects will be considered.  A written consent will be 
obtained from each patient enrolled in the study after providing comprehensive 
information about the nature of the study, aim, benefits, risks, compensation, and 
alternative treatment.  The researcher will emphasize that participation is absolutely 
voluntary.  Participants will be informed that they have the right to refuse to 
participate in the study and withdrawn at any time and the refusal to participate in the 
study will not affect their care.  Anonymity, privacy, safety, and confidentiality will be 
assured throughout the whole study. 
 

 
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Statistical Analysis 
The collected data will be coded, tabulated, and analyzed using Statistical 
Package for the Social Science (SPSS) program version 22.  Appropriate statistical 
tests will be used. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Results 
Data collection will be presented in tables, graphs, and figures. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Discussion 
The results of this study will be discussed in the light of relevant, similar 
studies nationally and internationally. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Conclusion and Recommendations 
Appropriate conclusion and recommendations will be drawn based upon the 
study findings and discussion. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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