Use of Acupressing in Reproductive Medicine

Not Applicable

Recruiting

• Conditions: Anxiety State; Fertility Disorders
• Interventions: Other: Acupressing; Other: Control

• Registration Number: NCT05815121
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study First Submitted: 2023-02-08
• Study Start: 2023-02-09
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 82

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupressing group	Acupressing	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
SHAM group	Control	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.

Primary Outcome Measures

Name	Time	Method
Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.	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 Outcome Measures

Name	Time	Method
Absolute difference measurement between inclusion and when leaving the recovery room	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
Absolute difference measurement between the baseline and the immediate preoperative measurement	between baseline to the immediate preoperative measurement	Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
Absolute difference measurement between baseline and day 1	up 24 hours after treatment	Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
Pain score measured by numeric scale when leaving the recovery room	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
Postoperative nausea and vomiting occurring	In the recovery room (up to 2 hours)	Proportion of patients declaring postoperative nausea and vomiting occurring during the stay in the recovery room
Postoperative retention of urine	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
Satisfaction questionnaire	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
Quality of sleep measurement	up 24 hours after treatment	Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.
Tolerance of acupressing treatment	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

Trial Locations

Locations (1)

Foch Hospital; 🇫🇷 Suresnes, France