The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study
Phase: NA
Conditions: Gastrointestinal Dysfunction, Anxiety, Pain, Postoperative
Sponsor: Kahramanmaras Sutcu Imam University

 
 
 
STUDY PROTOCOL 
 
STATİSTİCAL ANALYSİS PLAN (SAP) 
 
INFORMED CONSENT FORM (ICF) 
 
 
 
 
 
Human Subjects Review Approved Dated: 10.09.2018 
 
 
 
 
 
 
 
 
10.10.2018 
 
 

 
STUDY PROTOCOL 
1.1.  Study Design and Patient Selection 
This study was designed as a randomised, 3-way blinded, placebo-controlled study to 
determine the effect on GIS functions, pain and anxiety of acupressure applied for a total of 
12 mins, as 3 mins at each of the ST25, CV12, TH6, and HT7 acupuncture points, at 0, 4 and 
8 hours after laparoscopic cholecystectomy operation.  
Patients were randomly assigned to the intervention and placebo groups in this clinical study. 
The study group was formed of patients who underwent laparoscopic cholecystectomy in a 
state hospital in Turkey.  
1.2. Anaesthesia protocol 
All patients received 2 mg of midazolam intravenously in the premedication unit 5 minutes 
before surgery. For anesthesia induction, tracheal intubation was performed with the 
simultaneous use of rocuronium bromide 0.6 mg / kg, intravenous propofol 2-2.5 mg / kg and 
fentanyl 2 mcg / kg, at 4 l / min 100% O2. IV remifentanil was set at 0.25 mcg / kg / min and 
0.2 mg / kg rocuronium bromide was given intravenously every 30 minutes. After tracheal 
intubation, the inhalation gas desflurane was adjusted to 6% concentration. All patients were 
intraoperatively administered metoclopramide 10 mg and ranitidine HCl 20 mg. Remifentanil 
infusion and inhalation agent were discontinued after the last skin suture was made. When 
spontaneous breathing started, muscle relaxant was administered (neostigmine 0.05 mg / kg 
and atropine 0.015 mg / kg), and patients were extubated when sufficient muscle strength and 
spontaneous breathing were available. After surgery, 4 milligrams of ondansetron was 
administered intravenously to patients who had nausea and vomiting.  
1.3. Process and Intervention 
Intestinal sounds were listened to with the same stethoscope, by dividing the abdomen into 4 
quadrants and evaluating each quadrant. A time of one minute was set on a chronometer for 
each evaluation, and the number of the intestinal sounds in one minute were counted and 
recorded. To prevent errors in the evaluations, the accuracy of the measurements was 
confirmed by a doctor at the same time. Patients who had been discharged before gas output 
and defecation were telephoned and questioned about the times of these outputs. The 
applications made to the intervention and the placebo group are shown in Table 1.1. 
 

Table 1.1. Applications made to the Intervention Group and the Placebo Group 
 
Preop 
Periop 
Postop 
Before 
acupressure 
After acupressure 
0 hour 
4 
hours 
8 
hours 
Informed consent 
X 
 
 
 
 
 
 
Sosyodemographic 
characteristics 
X 
 
 
 
 
 
 
Clinical 
characteristics 
X 
X 
X 
 
 
 
 
TAI 
X 
 
 
 
 
 
 
Blood pressure-pulse 
 
 
 
X 
X 
X 
X 
Intestinal sounds 
 
 
 
X 
X 
X 
X 
First flatus 
 
 
 
X 
X 
X 
X 
First defecation 
 
 
 
X 
X 
X 
X 
Pain  
 
 
 
X 
X 
X 
X 
Nausea  
 
 
 
X 
X 
X 
X 
Vomiting  
 
 
 
X 
X 
X 
X 
SAI 
 
 
 
X 
 
 
X 
 
 
1.4. Safety Evaluation 
Stimulation of the acupuncture points due to the prolongation of the fasting period before the 
surgery may decrease the blood glucose level of the patient. Therefore, the patient was 
observed in terms of symptoms such as pallor and apathy during acupressure. In addition, 
patients were observed in terms of side effects such as bruising, bleeding and increased pain 
during the application. No complications developed in patients. 
 
Acupressure steps 
Informed consent for the procedure was obtained from each patient then acupressure was 
applied using the following steps. 
1. The hands of the practitioner were washed with warm water. 

2. The patient was positioned supine or half- sitting in a comfortable position with the knees 
slightly bent and the support of a small pillow under the knees.    
3. The ST 25, CV 12 and TH 6 acupuncture points to be used were determined using 
measurements of the patient’s fingers. 
4. Acupressure was applied for 3 minutes at each point starting from HT 7, then moving to 
TH6, ST 25, and CV 12. 
5. Using the tips of the thumbs of both hands, pressure was applied for 10 seconds 
continuously then rested for 2 seconds, and this cycle was repeated for 3 mins.    
6. The level of pressure applied was adjusted according to the tolerance level of the patient. 
VAS was used to evaluate positive pain, and the feeling of fullness or heat (Deqi). 
Evaluation of the intensity was controlled at 5.  
7. The acupressure procedure was performed 3 times at 0, 4 and 8 hours postoperatively.
 
 
1.5. Sapmle size 
The population of the study consisted of adult patients who underwent laparoscopic 
cholecystectomy. Between July 2018 and July 2019, 132 patients underwent surgery. Tan et 
al. (2016), the sample of the study was determined by power analysis using the difference (4 
hours) between the first flatus time of the patients after laparoscopic cholecystectomy in the 
experimental and placebo group. A total of 60 patients were planned to be included in the 
study, 30 of which were experiments and 30 were placebo. According to the results obtained 
for the State Anxiety Inventory with post-power analysis applied to the data obtained in the 
study, it was deemed necessary to include a total of 53 patients in the study, as 26 in the 
intervention group and 27 in the placebo group for power size of 0.006 and statistical powere 
of 0.087 with 5% type 1 error for two-way variance analysis of repeated measurements. 
Randomisation: Patients were randomly assigned to the intervention and placebo groups in 
this clinical study.  65 patients who met the inclusion criteria were included in the study.  
53 patients included in the study were randomly assigned to 2 groups. For randomization, the 
randomization list produced in a computer program that produces random numbers as 
numbers 1 and 2 was used. Patients were randomized into intervention and placebo groups in 
order of hospitalization using the randomization list (http://www.randomizer.org/form.htm).  
 

1.6. Ethical Approval 
Approval for the study was granted by the Ethics Committee of Kahramanmaraş Sütçü Imam 
University Medical Faculty, and the Academic Committe of Erciyes University health 
Sciences Faculty (Decision no: 2018/10). Written permission was obtained from the Medical 
Director of Kahramanmaraş Sütçü Imam University Medical Faculty Hospital. Verbal and 
written informed consent was obtained from all the patients in the study.  
Author contributions 
Dilek Soylu: Conceptualisation, methodology, formal analysis, data collection, evaluation, 
manuscript writing, original design, checking and corrections.  
Pınar Tekinsoy Kartın: Conceptualisation, methodology, formal analysis, manuscript 
writing,  checking and corrections.  
Conflict of Interests 
The authors have no conflict of interests to declare  
Acknowledgements 
The authors thank all those who participated in this study, and special thanks to the ward 
nurses for assistance at the stage of data collection. 
Financial Disclosure 
No funds have been received in respect of this study from any public or private institution. 
 
 
 
 
 
 
 
 
 

STATİSTİCAL ANALYSİS PLAN (SAP) 
Data obtained in the study were analysed statistically using IBM SPSS software (IBM 
Corporation, Armonk, NY, USA). Conformity of the data to normal distribution was assessed 
with the Shapiro Wilk test. In the comparison of the two groups, the Independent Samples t-
test was applied to age, BMI, and TAI points showing normal distribution and the Mann 
Whitney U-test to clinical variables not showing normal distribution. For internal consistency 
of the scales, the Cronbach alpha coefficients were calculated.  The systolic and diastolic 
blood pressure, pulse and VAS values before and after acupressure at 0, 4 and 8 hours showed 
normal distribution so intergroup comparisons were made with Two-Way Variance analysis 
on the repeated measurements from the general linear models. Bonferroni correction was 
applied when comparing the main effects. In the inter-group comparisons of intestinal sound, 
gas output, defecation, distension and nausea, which did not show normal distribution, the 
Mann Whitney U-test was used and in the intra-group comparsions, Friedman analysis. When 
differences were found in the intra-group values, multiple comparison tests with Bonferroni 
correction were used. Correlations between the scales were evaluated with Pearson correlation 
analysis. The relationships between categorical variables in the groups were examined with 
the Pearson Chi-square Exact test in 2 x2 and r x c tables. When a correlation was determined 
in the Chi-square test, the difference in the categories between the groups was determined 
with the Bonferroni corrected two ratio z-test. A value of p<0.05 was accepted as statistically 
significant.  
 
 
 
 
 
 
 
 
 

 
INFORMED CONSENT FORM (ICF) (INTERVENTION GROUP) 
In this research, after laparoscopic cholecystectomy surgery, acupressure will be applied to 
ST 25, CV 12 and TH 6 acupuncture points for 3 minutes and 15 minutes in total at 0, 4 and 8 
hours. It will be performed to determine the effect of acupressure on postoperative 
gastrointestinal system functions (bowel movements, gas-stool output, nausea-vomiting), pain 
and anxiety. During this study, acupressure will be applied and compared with the other 
group. We think that this application may have a positive effect on your gastrointestinal 
system functions and anxiety problems that you experience due to your treatment. 
Acupressure application and evaluation will be done by the researcher at 0, 4 and 8 hours 
postoperatively. You are free to participate in this work. You can accept it at the beginning, 
then change your mind and leave the study without any reason. In this case, there will be no 
change in medical care about you.  
Acupressure application and evaluation will be done by the researcher at 0, 4 and 8 hours 
postoperatively. You are free to participate in this work. You can accept it at the beginning, 
then change your mind and leave the study without any reason. In this case, there will be no 
change in medical care about you. 
Thank you. 
The researcher; 
Name-Surname: Dilek SOYLU   Tel: *** *** **** 
Consent to Participate in the Study: 
Participant's statement: “I have read all the explanations on the Informed Consent Form. 
Written and verbal explanation about the research whose subject and purpose was mentioned 
above was given to me by the research director. I know that I can leave this study without any 
justification. I agree to participate in the aforementioned research of my own free will, 
without any pressure or coercion. " 
Participant 
Name Surname: Date: ..… /… ../ …… 
Tel: Signature 
 

INFORMED CONSENT FORM (ICF) (PLESABO GROUP) 
In this research, after laparoscopic cholecystectomy surgery, acupressure will be applied to 
ST 25, CV 12 and TH 6 acupuncture points for 3 minutes and 15 minutes in total at 0, 4 and 8 
hours. It will be performed to determine the effect of acupressure on postoperative 
gastrointestinal system functions (bowel movements, gas-stool output, nausea-vomiting), pain 
and anxiety. Acupressure application and evaluation will be done by the researcher at 0, 4 and 
8 hours postoperatively. You are free to participate in this work. You can accept it at the 
beginning, then change your mind and leave the study without any reason. In this case, there 
will be no change in medical care about you.  
Acupressure application and evaluation will be done by the researcher at 0, 4 and 8 hours 
postoperatively. You are free to participate in this work. You can accept it at the beginning, 
then change your mind and leave the study without any reason. In this case, there will be no 
change in medical care about you. 
Thank you. 
The researcher; 
Name-Surname: Dilek SOYLU   Tel: *** *** **** 
Consent to Participate in the Study: 
Participant's statement: “I have read all the explanations on the Informed Consent Form. 
Written and verbal explanation about the research whose subject and purpose was mentioned 
above was given to me by the research director. I know that I can leave this study without any 
justification. I agree to participate in the aforementioned research of my own free will, 
without any pressure or coercion. " 
Participant 
Name Surname: Date: ..… /… ../ …… 
Tel: Signature