Use of Acupressing in Reproductive Medicine

NCT05815121 | Completed

• 1 other identifier: 2021_0165
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders; Anxiety State

Keywords

Acupressing; oocyte; women; fertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Absolute difference measurement between the baseline and the immediate preoperative measurement

  between baseline to the immediate preoperative measurement

• Absolute difference measurement between inclusion and when leaving the recovery room

  before procedure to time when leaving the recovery room (up to 2 hours)

• Absolute difference measurement between baseline and day 1

  up 24 hours after treatment

• Pain score measured by numeric scale when leaving the recovery room

  When leaving the recovery room (up to 2 hours)

• Postoperative nausea and vomiting occurring

  In the recovery room (up to 2 hours)

Study Arms (2)

Acupressing group

EXPERIMENTAL

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

SHAM group

SHAM COMPARATOR

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

Interventions

Acupressing OTHER

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

Acupressing group

Control OTHER

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

SHAM group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Femal with 18 years and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch Hospital

Suresnes, 92150, France

Location

Related Publications (14)

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  PMID: 23245838 BACKGROUND

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  PMID: 7402685 BACKGROUND

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  PMID: 34781116 BACKGROUND

• Saku K, Mukaino Y, Ying H, Arakawa K. Characteristics of reactive electropermeable points on the auricles of coronary heart disease patients. Clin Cardiol. 1993 May;16(5):415-9. doi: 10.1002/clc.4960160509.

  PMID: 8504576 BACKGROUND

• Ceccherelli F, Gagliardi G, Seda R, Corradin M, Giron G. Different analgesic effects of manual and electrical acupuncture stimulation of real and sham auricular points: a blind controlled study with rats. Acupunct Electrother Res. 1999;24(3-4):169-79. doi: 10.3727/036012999816356309.

  PMID: 10768414 BACKGROUND

• He W, Wang X, Shi H, Shang H, Li L, Jing X, Zhu B. Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med. 2012;2012:786839. doi: 10.1155/2012/786839. Epub 2012 Nov 27.

  PMID: 23304215 BACKGROUND

• Usichenko TI, Mustea A, Pavlovic D. On ears and Head. Acupunct Med. 2010 Dec;28(4):165-6. doi: 10.1136/aim.2010.003244. No abstract available.

  PMID: 21148074 BACKGROUND

• Mora B, Iannuzzi M, Lang T, Steinlechner B, Barker R, Dobrovits M, Wimmer C, Kober A. Auricular acupressure as a treatment for anxiety before extracorporeal shock wave lithotripsy in the elderly. J Urol. 2007 Jul;178(1):160-4; discussion 164. doi: 10.1016/j.juro.2007.03.019. Epub 2007 May 17.

  PMID: 17499304 BACKGROUND

• Qu F, Zhang D, Chen LT, Wang FF, Pan JX, Zhu YM, Ma CM, Huang YT, Ye XQ, Sun SJ, Zheng WJ, Zhang RJ, Xu J, Xing LF, Huang HF. Auricular acupressure reduces anxiety levels and improves outcomes of in vitro fertilization: a prospective, randomized and controlled study. Sci Rep. 2014 May 22;4:5028. doi: 10.1038/srep05028.

  PMID: 24848522 BACKGROUND

• Williams VS, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010 Jun 8;8:57. doi: 10.1186/1477-7525-8-57.

  PMID: 20529361 BACKGROUND

• Tian M, Huang Y, Wang X, Cao M, Zhao Z, Chen T, Yuan C, Wang N, Zhang B, Li C, Zhou X. Vaccaria segetalis: A Review of Ethnomedicinal, Phytochemical, Pharmacological, and Toxicological Findings. Front Chem. 2021 Apr 29;9:666280. doi: 10.3389/fchem.2021.666280. eCollection 2021.

  PMID: 33996757 BACKGROUND

• Nielsen A, Gereau S, Tick H. Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Pain Med. 2020 Jun 1;21(6):1276-1293. doi: 10.1093/pm/pnz379.

  PMID: 32430505 BACKGROUND

• Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct for parental presence during induction of anesthesia. Anesthesiology. 2004 Jun;100(6):1399-404. doi: 10.1097/00000542-200406000-00011.

  PMID: 15166558 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mireille MICHEL-CHERQUI, MD

  Foch Hospital

  PRINCIPAL INVESTIGATOR

• Sabrina MA HAR, MD

  Foch Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel goup, single

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: April 18, 2023
• Study Start: February 9, 2023
• Primary Completion: March 11, 2023
• Study Completion: March 11, 2023
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)