Postoperative PainNCT05360173
The Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function After Laparoscopic Surgery
A study testing acupressure in people with Postoperative Pain, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Explore the Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function of Patients After Laparoscopic Surgery
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- acupressure, sham acupressure
- Keywords
- Laparoscopic surgery, post-operative pain, acupressure, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
The researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg.
sham acupressureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: acupressure |
| Control group | Sham comparator | The control group will have the same treatment and the evaluation, except received sham acupoint. Receives: Behavioral: sham acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
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.
Measured: 3 days
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.
Measured: 3 days
Secondary outcomes (4)
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.
Measured: 3 days
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.
Measured: 3 days
Timing of first flatus
asking the patient the timing of the first flatus after surgery, time is the shorter the better
Measured: 3 days
postoperative length of stay
recording from the chart, time is the shorter the better
Measured: Postoperative day to discharge (about 5-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start16 Jun 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Li Chen, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360173
- Sponsor's protocol ID
- DMR-111-166
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function of Patients After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05360173
- Acronym / sponsor ID
- DMR-111-166
- Conditions
- Postoperative Pain
- Keywords
- Laparoscopic surgery, post-operative pain, acupressure, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: acupressureThe 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. |
| Control group | Sham comparator | Behavioral: sham acupressureThe control group will have the same treatment and the evaluation, except received sham acupoint. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressureThe researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg. | Behavioural | Experimental group |
| sham acupressureThe 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. | Behavioural | Control group |
Primary outcome
Postoperative pain intensity
Time frame: 3 days
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
Time frame: 3 days
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
Time frame: 3 days
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.
4 secondary outcomes
Times of exhaust air
Time frame: 3 days
recovery of bowel movement
Time frame: 3 days
Timing of first flatus
Time frame: 3 days
postoperative length of stay
Time frame: Postoperative day to discharge (about 5-7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Postoperative Pain, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.