Use of Acupressing in Reproductive Medicine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fertility Disorders, Anxiety State

Intervention / Treatment
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* Other: Acupressing
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel goup, single
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressing group<br>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<br>* Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.<br>|
| Sham Comparator: SHAM group<br>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<br>* with stickers only on the points, and the points should not be massaged.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Quality of sleep measured using the SPIEGEL questionnaire the day after treatment. | up 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressing, oocyte, women, fertility