Anxiety Clinical Trial
Official title:
The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study
NCT number | NCT04606485 |
Other study ID # | Interventional |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | May 1, 2019 |
Verified date | October 2020 |
Source | Kahramanmaras Sutcu Imam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Di?lek Soylu | Kahramanmaras |
Lead Sponsor | Collaborator |
---|---|
Kahramanmaras Sutcu Imam University |
Turkey,
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. — View 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. — View 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 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the first flatus process according to the information received from the patient | First flatus hour is validated, the patient was questioned about the time of flatus output. The hour reported by the patient was evaluated as the time of first flatus. Change=(Postoperative 0 and 72 hours). | Postoperative 0 and 72 hours | |
Primary | Change in the first gaits output process according to the information received from the patient | First gaits output is validated, the patient was questioned about the time of gaits output. The hour reported by the patient was evaluated as the time of first gaits.Change=(Postoperative 0 and 72 hours). | Postoperative 0 and 72 hours | |
Primary | Change from Baseline in Pain on The Numeric Pain Intensity Scale (NAS) at postoperative 0, 4 and 8 hours. | NAS is a single dimension, subjective scale, consisting of a horizontal line, marked at equal intervals from 0-10, where 0= no pain and 10= intolerable pain. The scores were evaluated as 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain. The patients were instructed to mark the number best reflecting the level of pain felt.It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure score- postoperative 0, 4 and 8 hours scores). | Pre-acupressure, postoperative 0, 4 and 8 hours | |
Primary | Change from Baseline The State-Trait Anxiety Inventory (SAI) at pre-acupressure and postoperative 8 hour | The State-Trait Anxiety Inventory was developed by Spielberger in 1964 and was adapted to Turkish by Öner and LeCompte. The scale, which is self-reported and consists of short statements, measures the levels of anxiety of both patients and healthy individuals. The State Anxiety Inventory (SAI) provides information about how the individual feels at that time, and the Trait Anxiety Inventory (TAI) about how they have felt in the last 7 days.
The constant value is 50 for the SAI and 35 for the TAI. The most recently obtained value constitutes the anxiety points, in a maximum range of 20-80, with high scores indicating a high level of anxiety. Change= (Pre-acupressure score and postoperative 8 hour score). |
Pre-acupressure and postoperative 8 hour | |
Secondary | Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours. | A 10 cm scale, marked in cm, where 0= no nausea and 10= very severe nausea was used and each patient was instructed to mark the greatest severity of nausea that they had felt on the scale. It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure score- postoperative 0, 4 and 8 hours score). | Pre-acupressure, postoperative 0, 4 and 8 hours | |
Secondary | Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours. | 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. It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure number- postoperative 0, 4 and 8 hours numbers). | Pre-acupressure, postoperative 0, 4 and 8 hours |
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