Use of Acupressing in Reproductive Medicine (ambauric)

April 1, 2025 updated by: Hopital Foch

Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery

The objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. In addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. Acupuncture could also help these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infertility can lead to the realization of follicular puncture or oocytes in order to obtain an embryo for medically assisted procreation. It is a long treatment for the couples concerned and this intervention, relatively simple in young patients, is associated with a very high level of anxiety. According to studies, the incidence of preoperative anxiety ranges from 11% to 80% in adult patients. In patients undergoing outpatient surgery, anxiolytics are not administered before anesthesia in outpatient surgery, as this would risk altering their "fitness for the street" and preventing their return home. Studies have shown a benefit of acupressing in the treatment of preoperative anxiety. This technique could therefore be an alternative to drug anxiety before surgery. Acupressing could also help these patients.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • 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 Locations

  • France
      • Suresnes, France, 92150
        • Foch Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years old
  • Scheduled to undergo an oocyte retrieval in outpatient surgery
  • Anxiety score ≥ 3 when they arrived in the outpatient unit
  • Subject is willing and able to provide informed consent
  • Covered by a national healthcare insurance

Non-Inclusion Criteria:

  • Ear's pavilion infection
  • Wrist infection
  • Previous treatment with auriculotherapy or acupuncture
  • With a planned intervention that does not allow the delay of 45 min delay (+/- 15 min) between the acupuncture treatment and the STAI assessment
  • Being deprived of liberty or under guardianship

Exclusion criteria

  • Patient having recourse to any treatment or method of anxiolysis the morning of the procedure, after having given her consent
  • Patient wishing to withdraw from the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressing group

Patients benefit from one session of acupressing with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.

They will also be asked to regularly and gently massage the treated points
Other: Acupressing
Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.
Sham Comparator: SHAM group
Patients treated according to the same scheme as the experimental group, but with stickers only on the points, and the points should not be massaged.
Other: Control
with stickers only on the points, and the points should not be massaged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.
Time Frame: Baseline to 45 minutes after treatment

Anxiety assessed by the State-Trait Anxiety Inventory questionnaire. It consists of an auto-administered test of 20 items evaluating each item from 0 to 3 on the Likert scale (0= almost never, 1 = sometimes, 2 = often, 3 = almost always).

The primary endpoint is the absolute difference in the state anxiety score measured between the baseline measurement and the measurement 45 minutes after treatment.
Baseline to 45 minutes after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute difference measurement between the baseline and the immediate preoperative measurement
Time Frame: between baseline to the immediate preoperative measurement
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
between baseline to the immediate preoperative measurement
Absolute difference measurement between inclusion and when leaving the recovery room
Time Frame: before procedure to time when leaving the recovery room (up to 2 hours)
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
before procedure to time when leaving the recovery room (up to 2 hours)
Absolute difference measurement between baseline and day 1
Time Frame: up 24 hours after treatment
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
up 24 hours after treatment
Pain score measured by numeric scale when leaving the recovery room
Time Frame: When leaving the recovery room (up to 2 hours)
Pain score measured by numeric scale (0-10). 0 corresponding to no pain and 10 more pain
When leaving the recovery room (up to 2 hours)
Postoperative nausea and vomiting occurring
Time Frame: In the recovery room (up to 2 hours)
Proportion of patients declaring postoperative nausea and vomiting occurring during the stay in the recovery room
In the recovery room (up to 2 hours)
Postoperative retention of urine
Time Frame: In the recovery room (up to 2 hours)
Proportion of patients declaring retention of urine or the need for catheterization for absence or delay in urination occurring during the stay in the recovery room
In the recovery room (up to 2 hours)
Tolerance of acupressing treatment
Time Frame: In the recovery room (up to 2 hours)
The presence or absence of pain and discomfort in the recovery room attributed to the treatment of acupuncture by the patient
In the recovery room (up to 2 hours)
Satisfaction questionnaire
Time Frame: In the recovery room (up to 2 hours)
Proportion of patients answering yes to the question "if you had to do it again, would you choose the same technique?" " when leaving the recovery room
In the recovery room (up to 2 hours)
Quality of sleep measurement
Time Frame: up 24 hours after treatment
Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.
up 24 hours after treatment

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Study Director: Sabrina MA HAR, MD, Foch Hospital
  • Principal Investigator: Mireille MICHEL-CHERQUI, MD, Foch Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 9, 2023

Primary Completion (Actual)

March 11, 2023

Study Completion (Actual)

March 11, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_0165

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

product manufactured in and exported from the U.S.

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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