Does Acupressure Affect Gastrointestinal Function, Pain and Anxiety?

NCT04606485 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction; Anxiety; Pain, Postoperative

Keywords

Acupressure; Gastrointestinal Dysfunction; Anxiety; Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours.

  Pre-acupressure, postoperative 0, 4 and 8 hours

• Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours.

  Pre-acupressure, postoperative 0, 4 and 8 hours

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

Acupressure OTHER

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.

Experimental group; Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Di̇lek Soylu

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28483182 RESULT

• 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.

  PMID: 23448746 RESULT

• 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.

  PMID: 25276717 RESULT

• 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.

  PMID: 14696681 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Di̇lek Soylu

  Kahramanmaras Sutcu Imam universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 28, 2020
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)