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Gastrointestinal MotilityNCT06320613

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

A study testing Acupuncture therapy and Ginger Acupuncture Point Patch in people with Gastrointestinal Motility and Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Acupuncture therapy and Ginger Acupuncture Point Patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
20 Mar 2024to 20 Sep 2024
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I or II;
  • Performing gynecologic laparoscopic procedures under general anesthesia;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lin Cheng, B.S contact

17667404256

1318216353@qq.com

China1 site, 1 recruiting
  • Lin Cheng

    Weifang, Shandong, 261000

    Lin Cheng, B.S, 17667404256, 1318216353@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Acupuncture therapy, Ginger Acupuncture Point Patch
Keywords
Gastrointestinal Motility, Recovery of Function, PONV
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture therapyOther

    Also called Qin acupuncture therapy, snap-needle 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.

  • Ginger Acupuncture Point PatchOther

    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.

Study groups in NCT06320613
Study groupRoleWhat they receive
Experimental group acupuncture(snap-needle)Active comparatorPatients 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.
Receives: Other: Acupuncture therapy
Experimental GingerActive comparatorPatients 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.
Receives: Other: Ginger Acupuncture Point Patch
Experimental group Acupuncture combined with gingerActive comparatorPatients 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.
Receives: Other: Acupuncture therapy; Other: Ginger Acupuncture Point Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative nausea and vomiting

    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: Measured at 0.5 hours postoperatively.

  2. Postoperative nausea and vomiting

    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: Measured at 1 hours postoperatively.

  3. Postoperative nausea and vomiting

    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: Measured at 3 hours postoperatively.

  4. Postoperative nausea and vomiting

    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: Measured at 6 hours postoperatively.

  5. Postoperative nausea and vomiting

    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: Measured at 12 hours postoperatively.

  6. Postoperative nausea and vomiting

    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: Measured at 24 hours postoperatively.

  7. Abdominal distention

    The severity and incidence of Abdominal distention at 0.5 hours postoperatively.

    Measured: Measured at 0.5 hours postoperatively.

  8. Abdominal distention

    The severity and incidence of Abdominal distention at 1 hours postoperatively.

    Measured: Measured at 1 hours postoperatively.

  9. Abdominal distention

    The severity and incidence of Abdominal distention at 3 hours postoperatively.

    Measured: Measured at 3 hours postoperatively.

  10. Abdominal distention

    The severity and incidence of Abdominal distention at 6 hours postoperatively.

    Measured: Measured at 6 hours postoperatively.

  11. Abdominal distention

    The severity and incidence of Abdominal distention at 12 hours postoperatively.

    Measured: Measured at 12 hours postoperatively.

  12. Abdominal distention

    The severity and incidence of Abdominal distention at 24 hours postoperatively.

    Measured: Measured at 24 hours postoperatively.

  13. Time to first flatus

    Record the time of the first flatus. The earlier the time of first flatus, the earlier the time of recovery of gastrointestinal function.

    Measured: Approximately 24 hours after surgery.

Secondary outcomes (9)
  1. Postoperative pain response

    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: Measured at 0.5 hours postoperatively.

  2. Postoperative pain response

    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: Measured at 1 hours postoperatively.

  3. Postoperative pain response

    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: Measured at 3 hours postoperatively.

  4. Postoperative pain response

    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: Measured at 6 hours postoperatively.

  5. Postoperative pain response

    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: Measured at 12 hours postoperatively.

  6. Postoperative pain response

    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: Measured at 24 hours postoperatively.

  7. Consumption of postoperative analgesic

    Record the type and dosage of postoperative analgesic within 24 hours after surgery.

    Measured: Approximately 24 hours after surgery.

  8. Consumption of postoperative rescue antiemetic

    Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.

    Measured: Approximately 24 hours after surgery

  9. Time to first defecation

    Record the time of first defecation.

    Measured: Approximately 24 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start20 Mar 2024 (estimated)
  3. Primary completion20 Sep 2024 (estimated)
  4. Study completion20 Sep 2024 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06320613
Sponsor's protocol ID
KYLL20240117-2
Status last verified
Mar 2024
First submitted
1 Mar 2024
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture therapy and Ginger Acupuncture Point Patch in people with Gastrointestinal Motility and Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.

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 2 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Contact Lin Cheng, B.S (17667404256, 1318216353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative nausea and vomiting (time frame: Measured at 0.5 hours postoperatively.). The study lists 13 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 20 Mar 2024.

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