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Completed

NCT Number: NCT05815121

Use of Acupressing in Reproductive Medicine

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.

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Key information

Conditions

Fertility Disorders Anxiety Disorders Anxiety State Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Foch Hospital

Suresnes, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupressing

Other

Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.

Control

Other

with stickers only on the points, and the points should not be massaged.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Quality of sleep measurement

    Time frame: up 24 hours after treatment

    Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: ambauric

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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