Does Acupressure Affect Gastrointestinal Function, Pain and Anxiety?
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| ClinicalTrials.gov Identifier: NCT04606485 |
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Recruitment Status :
Completed
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Dysfunction Anxiety Pain, Postoperative | Other: Acupressure | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Acupressure was applied to both the intervention and placebo groups, by a single nurse researcher, trained in the application of acupressure. The nurse had received a certificate for attendance of an acupressure course which included theoretical and practical lessons for specialization on the subject of acupressure. Patients in the placebo group were unaware of their group. Patients were isolated from others by using acupressure in single rooms or by using a curtain around the bed. Thus, it was ensured that the patients were not affected by each other. Another nurse researcher blinded to the groups collected the data. The statistics specialist who analysed and reported the data was also blinded to the groups. Analysis and reporting were also defined as groups 1 and 2. Thus the 3-way blinded technique was used in this study. |
| Primary Purpose: | Supportive Care |
| Official Title: | The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study |
| Actual Study Start Date : | May 1, 2018 |
| Actual Primary Completion Date : | May 1, 2019 |
| Actual Study Completion Date : | May 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo group
Since acupressure administration was reported to have placebo effects, a placebo group was used to investigate the true effect of acupressure use. The application of placebo may consist of moderate pressure on an incorrect acupuncture point or a light touch on a real acupuncture point. This will allow us to determine the contribution of the placebo effect resulting from direct human contact and interaction in the light touch group. At postoperative 0, 4, and 8 hours, a light touch was applied to the ST25 (Stomach Meridian 25th point), CV12 (Conception Vessel Meridian 12th point), TH6 (Triple Heater Meridian 6th point) and HT7 (Shenmen point points) for one second. No patients experienced pain or a feeling of pressure. |
Other: Acupressure
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. |
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Experimental: Experimental group
As invasive acupuncture may cause hematoma and the wristband method of non-invasive acupressure may cause patient discomfort, itching, swelling of the wrist, and skin destruction, manual acupressure was applied in this study to reduce the risk of complications to a minimum. The frequency and duration of the application of acupressure was decided from a scan of literature and expert opinion. The first acupressure session was applied in the first postoperative hour immediately after routine treatment and care of the patients who came to the ward from the recovery unit. Acupressure by applying pressure with the thumbs for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, was performed at 0, 4 and 8 hours postoperatively. The acupuncture points were determined using the measurements of the patient's own fingers. |
Other: Acupressure
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. |
- Change in the first flatus process according to the information received from the patient [ Time Frame: Postoperative 0 and 72 hours ]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).
- Change in the first gaits output process according to the information received from the patient [ Time Frame: Postoperative 0 and 72 hours ]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).
- Change from Baseline in Pain on The Numeric Pain Intensity Scale (NAS) at postoperative 0, 4 and 8 hours. [ Time Frame: Pre-acupressure, 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).
- Change from Baseline The State-Trait Anxiety Inventory (SAI) at pre-acupressure and postoperative 8 hour [ Time Frame: 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).
- Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours. [ Time Frame: 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).
- Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours. [ Time Frame: 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).
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606485
| Turkey | |
| Di̇lek Soylu | |
| Kahramanmaraş, Turkey, 46100 | |
| Principal Investigator: | Di̇lek Soylu | Kahramanmaras Sutcu Imam universty |
Documents provided by Di̇lek Soylu, Kahramanmaras Sutcu Imam University:
| Responsible Party: | Di̇lek Soylu, Principal Investigator, Kahramanmaras Sutcu Imam University |
| ClinicalTrials.gov Identifier: | NCT04606485 |
| Other Study ID Numbers: |
Interventional |
| First Posted: | October 28, 2020 Key Record Dates |
| Last Update Posted: | October 28, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Our study has not been published yet |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Acupressure Gastrointestinal Dysfunction Anxiety Pain |
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Pain, Postoperative Anxiety Disorders Mental Disorders Postoperative Complications |
Pathologic Processes Pain Neurologic Manifestations |