Clinical trial NCT05815121: Use of Acupressing in Reproductive Medicine
Official title: Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Anxiety State
Keywords: Acupressing
oocyte
women
fertility
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel goup, single
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.
timeFrame: Baseline to 45 minutes after treatment
Secondary outcomes:
measure: Absolute difference measurement between the baseline and the immediate preoperative measurement
timeFrame: between baseline to the immediate preoperative measurement
measure: Absolute difference measurement between inclusion and when leaving the recovery room
timeFrame: before procedure to time when leaving the recovery room (up to 2 hours)
measure: Absolute difference measurement between baseline and day 1
timeFrame: up 24 hours after treatment
measure: Pain score measured by numeric scale when leaving the recovery room
timeFrame: When leaving the recovery room (up to 2 hours)
measure: Postoperative nausea and vomiting occurring
timeFrame: In the recovery room (up to 2 hours)
measure: Postoperative retention of urine
timeFrame: In the recovery room (up to 2 hours)
measure: Tolerance of acupressing treatment
timeFrame: In the recovery room (up to 2 hours)
measure: Satisfaction questionnaire
timeFrame: In the recovery room (up to 2 hours)
measure: Quality of sleep measurement
timeFrame: up 24 hours after treatment
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Foch Hospital
name: Mireille MICHEL-CHERQUI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foch Hospital
name: Sabrina MA HAR, MD
role: STUDY_DIRECTOR
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