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Use of Acupressing in Reproductive Medicine (ambauric)

Primary Purpose

Fertility Disorders, Anxiety State

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acupressing
Control
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Disorders focused on measuring Acupressing, oocyte, women, fertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Foch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupressing group

SHAM group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
Postoperative nausea and vomiting occurring
Proportion of patients declaring postoperative nausea and vomiting occurring during the stay in the recovery room
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
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
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
Quality of sleep measurement
Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.

Full Information

First Posted
February 8, 2023
Last Updated
April 3, 2023
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT05815121
Brief Title
Use of Acupressing in Reproductive Medicine
Acronym
ambauric
Official Title
Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Disorders, Anxiety State
Keywords
Acupressing, oocyte, women, fertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel goup, single
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressing group
Arm Type
Experimental
Arm Description
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
Arm Title
SHAM group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupressing
Intervention Description
Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
with stickers only on the points, and the points should not be massaged.
Primary Outcome Measure Information:
Title
Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.
Description
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.
Time Frame
Baseline to 45 minutes after treatment
Secondary Outcome Measure Information:
Title
Absolute difference measurement between the baseline and the immediate preoperative measurement
Description
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
Time Frame
between baseline to the immediate preoperative measurement
Title
Absolute difference measurement between inclusion and when leaving the recovery room
Description
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
Time Frame
before procedure to time when leaving the recovery room (up to 2 hours)
Title
Absolute difference measurement between baseline and day 1
Description
Anxiety score measured by numeric scale (0-10). 0 corresponding to no anxiety and 10 more anxiety
Time Frame
up 24 hours after treatment
Title
Pain score measured by numeric scale when leaving the recovery room
Description
Pain score measured by numeric scale (0-10). 0 corresponding to no pain and 10 more pain
Time Frame
When leaving the recovery room (up to 2 hours)
Title
Postoperative nausea and vomiting occurring
Description
Proportion of patients declaring postoperative nausea and vomiting occurring during the stay in the recovery room
Time Frame
In the recovery room (up to 2 hours)
Title
Postoperative retention of urine
Description
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
Time Frame
In the recovery room (up to 2 hours)
Title
Tolerance of acupressing treatment
Description
The presence or absence of pain and discomfort in the recovery room attributed to the treatment of acupuncture by the patient
Time Frame
In the recovery room (up to 2 hours)
Title
Satisfaction questionnaire
Description
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
Time Frame
In the recovery room (up to 2 hours)
Title
Quality of sleep measurement
Description
Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.
Time Frame
up 24 hours after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Femal with 18 years and older
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjolaine NGOLLO, PhD
Phone
01 46 25 37 49
Ext
+33
Email
drci-promotion@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar SELLAMI, PhD
Phone
01 46 25 31 37
Ext
+33
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille MICHEL-CHERQUI, MD
Organizational Affiliation
Foch Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabrina MA HAR, MD
Organizational Affiliation
Foch Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Foch Hospital
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjolaine NGOLLO, PhD
First Name & Middle Initial & Last Name & Degree
Mireille MICEHL-CHERQUI, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Use of Acupressing in Reproductive Medicine

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