Clinical trial NCT04606485: Does Acupressure Affect Gastrointestinal Function, Pain and Anxiety?
Official title: The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Dysfunction
Anxiety
Pain, Postoperative
Keywords: Acupressure
Gastrointestinal Dysfunction
Anxiety
Pain
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, 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. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 hours postoperatively.

Detailed description: Together with technological advances in the field of healthcare, there is currently a greater preference for the laparoscopic cholecystectomy procedure, as length of hospital stay is shorter, workforce loss is lower, good cosmetic results are obtained and postoperative patient satisfaction is higher, when compared to open cholecystectomy.

One of the basic factors affecting the patient is the anesthesia applied in the laparoscopic surgical approach. Following general anaesthesia, metabolic activity slows and gastrointestinal system (GIS) movements are reduced. In addition, by increasing intra-abdominal pressure, the gas insufflation applied to the peritoneal cavity in laparoscopic surgery, reduces blood flow in the stomach and small and large intestines. As a result of this reduced blood flow, ischemia and dysfunction in the intestines may cause ileus symptoms to emerge. Pain occuring as a response to surgical stress causes a decrease in intestinal motility. If pain is not brought under control postoperatively, nausea, vomiting, constipation and ileus may occur.

Preoperative anxiety has been reported to be associated with postoperative pain, cognitive disorders and delayed healing. Stress reaction, surgical intervention to the abdominal region, trauma, postoperative pain, and the use of anaesthetic and narcotic agents are among the factors causing the development of GIS problems. An increase in sympathetic activity which occurs in the stress reaction and the use of general/narcotic anaesthesia reduce gastrointestinal motility. Pharmacological treatments are applied to improve GIS functions. It has been reported that intravenous infusion of lidocaine in the perioperative period provides a faster recovery of bowel functions. Postoperative gastrointestinal dysfunction is usually treated using alvimopan, but the drug used has side effects such as nausea and vomiting. Postoperative pain and nausea-vomiting are common complaints after laparoscopic cholecystectomy, despite the use of multimodal analgesia consisting of dexamethasone, opioids, nonsteroidal anti-inflammatory drugs and local anesthetics used in the perioperative period. In addition, of the nursing applications used, the application of acupressure is of benefit. Acupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery. In studies of acupressure applied for the recovery of GIS functions, it has been reported that acupressure can be applied as non-invasive nursing care which improves postoperative ileus symptoms.

In a study by Chao et al, acupressure applied after abdominal surgery was reported to improve gas output, shorten the time to oral nutritional intake, and improve ileus symptoms. Acupressure applied to the P6 point following appendectomy decreased the frequency of vomiting. In another study, acupressure was determined to be effective in improving GIS movement. Acupressure improved intestinal functions but stated that more experimental studies were needed.

It is recommended to teach the use of acupuncture warning devices to patients with post-operative nausea, vomiting and anxiety problems. However, there is no definitive evidence as to when, how and for how long acupressure should be administered. Moreover, studies conducted by nurses on this subject are limited and studies with high evidence value are needed. As a result of our literature review, the effect of acupressure applied to ST25, CV12, TH6 and HT7 on bowel movements, first flatus and defecation time, pain and anxiety after laparoscopic cholecystectomy was not investigated. Therefore, our study was carried out to evaluate the effect of acupressure applied to patients after laparoscopic cholecystectomy on GIS functions, pain and anxiety.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Able to understand the information given
* Willing to receive acupressure
* No lesions or wounds in the areas where acupressure was to be applied
* Operated on under general anaesthesia pulse, blood pressure, body temperature and oxygen saturation values within normal range during the operation
* No failure or disorder developing intraoperatively or postoperatively related to fluid-electrolyte balance, acid-base balance, or tissue perfusion.

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status IV
* A requirement for simultaneous combined surgery,
* A need for postoperative fasting according to the preoperative evaluation or intraoperative findings (eg, panperitonitis with intraperitoneal abscess)
* Patients with a cardiac pacemaker
* A history of syncope or seizures
* Pregnant or lactating women
* The presence of any disease related to bleeding or a clotting disorder
* Patients who were unwilling to participate in the research.

Primary outcomes:
measure: Change in the first flatus process according to the information received from the patient
timeFrame: Postoperative 0 and 72 hours
measure: Change in the first gaits output process according to the information received from the patient
timeFrame: Postoperative 0 and 72 hours
measure: Change from Baseline in Pain on The Numeric Pain Intensity Scale (NAS) at postoperative 0, 4 and 8 hours.
timeFrame: Pre-acupressure, postoperative 0, 4 and 8 hours
measure: Change from Baseline The State-Trait Anxiety Inventory (SAI) at pre-acupressure and postoperative 8 hour
timeFrame: Pre-acupressure and postoperative 8 hour
Secondary outcomes:
measure: Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours.
timeFrame: Pre-acupressure, postoperative 0, 4 and 8 hours
measure: Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours.
timeFrame: Pre-acupressure, postoperative 0, 4 and 8 hours
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Di̇lek Soylu
Study officials:
affiliation: Kahramanmaras Sutcu Imam universty
name: Di̇lek Soylu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abadi F, Shahabinejad M, Abadi F, Kazemi M. Effect of Acupressure on Symptoms of Postoperative Ileus After Cesarean Section. J Acupunct Meridian Stud. 2017 Apr;10(2):114-119. doi: 10.1016/j.jams.2016.11.008. Epub 2016 Dec 27.
citation: Chao HL, Miao SJ, Liu PF, Lee HH, Chen YM, Yao CT, Chou HL. The beneficial effect of ST-36 (Zusanli) acupressure on postoperative gastrointestinal function in patients with colorectal cancer. Oncol Nurs Forum. 2013 Mar;40(2):E61-8. doi: 10.1188/13.ONF.E61-E68.
citation: Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.
citation: Chen LL, Hsu SF, Wang MH, Chen CL, Lin YD, Lai JS. Use of acupressure to improve gastrointestinal motility in women after trans-abdominal hysterectomy. Am J Chin Med. 2003;31(5):781-90. doi: 10.1142/S0192415X03001466.