Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy

March 12, 2024 updated by: Lin Cheng, Weifang Medical University

Effect of Using Snap-Needle Therapy in Combination With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy

The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Lin Cheng
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ASA I or II;
  2. Performing gynecologic laparoscopic procedures under general anesthesia;

Exclusion Criteria:

  1. Age ≤ 18 or ≥65;
  2. The patient has a previous history of PONV, digestive disorders, etc;
  3. Ulcers, infections, and skin tears at acupressure and acupuncture (snap-needle) treatment sites;
  4. Patients allergic to ginger；
  5. Inability to follow protocol or refusal to participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Experimental group acupuncture(snap-needle)
Patients in the acupuncture group received acupuncture therapy (snap-needle therapy) for 24 hours. Results of the study were collected at six assessment periods of 0-0.5 h, 0-1 h, 1-3 h, 4-6h, 6-12 h, and 12-24 h after anesthesia. Conducted by an independent researcher.
Other: Acupuncture therapy
After disinfecting (alcohol or 0.9% Normal saline) the skin at the acupuncture point, use small tweezers to clip the handle of the needle, remove the adhesive tape and stab the acupuncture point at a perpendicular angle, and then press the thumb with moderate pressure on the snap-needle embedded needle site in order for the patient to feel localized soreness and distension as appropriate. The snap-needle was removed after 24 hours, and the pressing time point remained unchanged.
Other Names:
  • Qin acupuncture therapy
  • snap-needle therapy
Active Comparator: Experimental Ginger
Patients in the Ginger Acupuncture Point Patch group received ginger patch therapy and the ginger patch was removed within 6h. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.
Other: Ginger Acupuncture Point Patch
Ginger was thinly sliced and then cut into 2-3cm diameter ginger discs according to a circular mold and covered with a sterile circular dressing. The ginger compress was removed within 6 hours.
Active Comparator: Experimental group Acupuncture combined with ginger
Patients in the Acupuncture combined with ginger group received acupuncture treatment (snap-needle therapy) combined with ginger compresses, which were removed within 6h and snap-needles were removed after 24 hours. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.
Other: Acupuncture therapy
After disinfecting (alcohol or 0.9% Normal saline) the skin at the acupuncture point, use small tweezers to clip the handle of the needle, remove the adhesive tape and stab the acupuncture point at a perpendicular angle, and then press the thumb with moderate pressure on the snap-needle embedded needle site in order for the patient to feel localized soreness and distension as appropriate. The snap-needle was removed after 24 hours, and the pressing time point remained unchanged.
Other Names:
  • Qin acupuncture therapy
  • snap-needle therapy
Other: Ginger Acupuncture Point Patch
Ginger was thinly sliced and then cut into 2-3cm diameter ginger discs according to a circular mold and covered with a sterile circular dressing. The ginger compress was removed within 6 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: Measured at 0.5 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.
Measured at 0.5 hours postoperatively.
Postoperative nausea and vomiting
Time Frame: Measured at 6 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 6 hours postoperatively.
Measured at 6 hours postoperatively.
Postoperative nausea and vomiting
Time Frame: Measured at 24 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 24 hours postoperatively.
Measured at 24 hours postoperatively.
Postoperative nausea and vomiting
Time Frame: Measured at 1 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 1 hours postoperatively.
Measured at 1 hours postoperatively.
Postoperative nausea and vomiting
Time Frame: Measured at 3 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 3 hours postoperatively.
Measured at 3 hours postoperatively.
Postoperative nausea and vomiting
Time Frame: Measured at 12 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 12 hours postoperatively.
Measured at 12 hours postoperatively.
Abdominal distention
Time Frame: Measured at 0.5 hours postoperatively.
The severity and incidence of Abdominal distention at 0.5 hours postoperatively.
Measured at 0.5 hours postoperatively.
Abdominal distention
Time Frame: Measured at 1 hours postoperatively.
The severity and incidence of Abdominal distention at 1 hours postoperatively.
Measured at 1 hours postoperatively.
Abdominal distention
Time Frame: Measured at 3 hours postoperatively.
The severity and incidence of Abdominal distention at 3 hours postoperatively.
Measured at 3 hours postoperatively.
Abdominal distention
Time Frame: Measured at 6 hours postoperatively.
The severity and incidence of Abdominal distention at 6 hours postoperatively.
Measured at 6 hours postoperatively.
Abdominal distention
Time Frame: Measured at 12 hours postoperatively.
The severity and incidence of Abdominal distention at 12 hours postoperatively.
Measured at 12 hours postoperatively.
Abdominal distention
Time Frame: Measured at 24 hours postoperatively.
The severity and incidence of Abdominal distention at 24 hours postoperatively.
Measured at 24 hours postoperatively.
Time to first flatus
Time Frame: Approximately 24 hours after surgery.
Record the time of the first flatus. The earlier the time of first flatus, the earlier the time of recovery of gastrointestinal function.
Approximately 24 hours after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Consumption of postoperative analgesic
Time Frame: Approximately 24 hours after surgery.
Record the type and dosage of postoperative analgesic within 24 hours after surgery.
Approximately 24 hours after surgery.
Postoperative pain response
Time Frame: Measured at 0.5 hours postoperatively.

The Visual Analog Score was used to assess pain response at 0.5 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 0.5 hours postoperatively.
Postoperative pain response
Time Frame: Measured at 24 hours postoperatively.

The Visual Analog Score was used to assess pain response at 24 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 24 hours postoperatively.
Postoperative pain response
Time Frame: Measured at 1 hours postoperatively.

The Visual Analog Score was used to assess pain response at 1 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 1 hours postoperatively.
Postoperative pain response
Time Frame: Measured at 3 hours postoperatively.

The Visual Analog Score was used to assess pain response at 3 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 3 hours postoperatively.
Postoperative pain response
Time Frame: Measured at 6 hours postoperatively.

The Visual Analog Score was used to assess pain response at 6 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 6 hours postoperatively.
Postoperative pain response
Time Frame: Measured at 12 hours postoperatively.

The Visual Analog Score was used to assess pain response at 12 hours postoperatively.

The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured at 12 hours postoperatively.
Consumption of postoperative rescue antiemetic
Time Frame: Approximately 24 hours after surgery
Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.
Approximately 24 hours after surgery
Time to first defecation
Time Frame: Approximately 24 hours after surgery.
Record the time of first defecation.
Approximately 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weifang Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weifang People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lin Cheng, B.S, Weifang People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KYLL20240117-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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