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The Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function After Laparoscopic Surgery

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupressure
sham acupressure
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Laparoscopic surgery, post-operative pain, acupressure, analgesia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • laparoscopic surgery on the organ of liver, gastric, small intestine, colon under general anaethesia
  • the American Society of Anesthesiologists (ASA) :I - III
  • above 20 years old
  • the state of consciousness is alert
  • Chinese or Taiwanese speaker

Exclusion Criteria:

  • surgical procedure: resection, low anterior resection, Roux-en-Y Gastric Bypass and Whipple procedure (pancreaticoduodenectomy)
  • postoperative length of hospital stay less than 3 days
  • patient have pregnant, maternity, breastfeeding, chronic pain history, coagulation disorder or skin injury on the acupoints.
  • drug abuse, alcoholism
  • Patient-controlled analgesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    The experimental group not only have the routine treatment, but have acupressure when they back to the ward with the following 3 days . The effectiveness evaluation was carried out by the same researcher before and after intervention. There are three assessments in this study: primary outcome including postoperative pain and bowel movement. The short-form McGill Pain Questionnaire is used to measure the quality of pain, Visual Analog Scale is used to the pain intensity and stethoscope is used to listen to the bowel sound. The study, also, will be recorded postoperative exhaust time, the postoperative date of Indwelling drainage tube and postoperative length of stay.

    The control group will have the same treatment and the evaluation, except received sham acupoint.

    Outcomes

    Primary Outcome Measures

    Postoperative pain intensity
    Visual Analog Scale (VAS) of pain is used to measure the pain intensity. The scale of 0 = no pain and 10 = the worst pain, is a 10 cm scale marked in cm. The higher scores means the worse outcome.
    The quality of postoperative pain
    The short-form McGill Pain Questionnaire (SF-MPQ) is used to measure the quality of pain. The Chinese version is used that consists of 16 descriptors (12 sensory; 4 affective) which rated 0 = none, 1 = mild, 2 = moderate or 3 = severe, and Present Pain Intensity (PPI) and a visual analogue scale (VAS). The higher score means the worse outcome.
    medication consumption
    The data is recorded from the patient chart about the drugs consumption after surgery. That is included opioid, non-steroidal anti-Inflammatory drugs, prokinetic agent and anti-flatulence drugs. The more medications are used mean the worse outcome.

    Secondary Outcome Measures

    Times of exhaust air
    The data is recorded by ask the patient whether they have exhaust air or not after intervention. If the patient has exhaust air after the intervention, means the good outcome.
    recovery of bowel movement
    The stethoscope is used to listen to the bowel sound, which will be measured by the researcher. The bowel sound increase means the good outcome.
    Timing of first flatus
    asking the patient the timing of the first flatus after surgery, time is the shorter the better
    postoperative length of stay
    recording from the chart, time is the shorter the better

    Full Information

    First Posted
    April 21, 2022
    Last Updated
    May 4, 2022
    Sponsor
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05360173
    Brief Title
    The Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function After Laparoscopic Surgery
    Official Title
    Explore the Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function of Patients After Laparoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 16, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to explore the effect if acupressure reducing pain after laparoscopic surgery. The study is designed as an experimental research with repeat measurement design. The patients who are eligible for laparoscopic for general surgery and colorectal surgery in a medical center in the central part of Taiwan. The intervention of the research starts from the first date of postoperative day and the patient has the postoperative pain. The participant will be randomized into experimental group and control group. These two groups will be given true acupressure and sham acupressure twice daily. The participant will be observation the postoperative pain and postoperative recovery.
    Detailed Description
    Laparoscopic is increasing in this decade. The surgical trauma caused postoperative pain which cannot be avoid. It is the significant challenge and the thorny issue of the healthcare providers, also, be discussed for many decades. Several clinical researches have been verified acupuncture and related method have been as adjuvant efficacy treatment for decreasing postoperative pain. Acupressure is the method of the thumb put acupoint, and therapeutic effectiveness is similar to acupuncture. Acupressure is allowed to a nurse work independently due to noninvasive treatment. However, the less of the clinical studies explore the efficacy of acupressure reducing the postoperative pain after laparoscopic. The result of the research will provide the efficacy of reducing postoperative laparoscopic pain and wish to improve the quality of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Laparoscopic surgery, post-operative pain, acupressure, analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    These two groups will be given true acupressure and sham acupressure twice daily. The participant will be observation the postoperative pain and postoperative recovery.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The experimental group not only have the routine treatment, but have acupressure when they back to the ward with the following 3 days . The effectiveness evaluation was carried out by the same researcher before and after intervention. There are three assessments in this study: primary outcome including postoperative pain and bowel movement. The short-form McGill Pain Questionnaire is used to measure the quality of pain, Visual Analog Scale is used to the pain intensity and stethoscope is used to listen to the bowel sound. The study, also, will be recorded postoperative exhaust time, the postoperative date of Indwelling drainage tube and postoperative length of stay.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    The control group will have the same treatment and the evaluation, except received sham acupoint.
    Intervention Type
    Behavioral
    Intervention Name(s)
    acupressure
    Intervention Description
    The researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg.
    Intervention Type
    Behavioral
    Intervention Name(s)
    sham acupressure
    Intervention Description
    The researcher use thumb and put about 3 kilogram on four acupoints where locating at about 3 cm next to the acupoint on the patient's arm and leg.
    Primary Outcome Measure Information:
    Title
    Postoperative pain intensity
    Description
    Visual Analog Scale (VAS) of pain is used to measure the pain intensity. The scale of 0 = no pain and 10 = the worst pain, is a 10 cm scale marked in cm. The higher scores means the worse outcome.
    Time Frame
    3 days
    Title
    The quality of postoperative pain
    Description
    The short-form McGill Pain Questionnaire (SF-MPQ) is used to measure the quality of pain. The Chinese version is used that consists of 16 descriptors (12 sensory; 4 affective) which rated 0 = none, 1 = mild, 2 = moderate or 3 = severe, and Present Pain Intensity (PPI) and a visual analogue scale (VAS). The higher score means the worse outcome.
    Time Frame
    3 days
    Title
    medication consumption
    Description
    The data is recorded from the patient chart about the drugs consumption after surgery. That is included opioid, non-steroidal anti-Inflammatory drugs, prokinetic agent and anti-flatulence drugs. The more medications are used mean the worse outcome.
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Times of exhaust air
    Description
    The data is recorded by ask the patient whether they have exhaust air or not after intervention. If the patient has exhaust air after the intervention, means the good outcome.
    Time Frame
    3 days
    Title
    recovery of bowel movement
    Description
    The stethoscope is used to listen to the bowel sound, which will be measured by the researcher. The bowel sound increase means the good outcome.
    Time Frame
    3 days
    Title
    Timing of first flatus
    Description
    asking the patient the timing of the first flatus after surgery, time is the shorter the better
    Time Frame
    3 days
    Title
    postoperative length of stay
    Description
    recording from the chart, time is the shorter the better
    Time Frame
    Postoperative day to discharge (about 5-7 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: laparoscopic surgery on the organ of liver, gastric, small intestine, colon under general anaethesia the American Society of Anesthesiologists (ASA) :I - III above 20 years old the state of consciousness is alert Chinese or Taiwanese speaker Exclusion Criteria: surgical procedure: resection, low anterior resection, Roux-en-Y Gastric Bypass and Whipple procedure (pancreaticoduodenectomy) postoperative length of hospital stay less than 3 days patient have pregnant, maternity, breastfeeding, chronic pain history, coagulation disorder or skin injury on the acupoints. drug abuse, alcoholism Patient-controlled analgesia

    12. IPD Sharing Statement

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    The Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function After Laparoscopic Surgery

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