AzTrials
AzTrials

Fertility DisordersambauricNCT05815121

Use of Acupressing in Reproductive Medicine

A study testing Acupressing in people with Fertility Disorders and Anxiety State, run by Hopital Foch at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fertility Disorders, Anxiety State
What is being tested?
Acupressing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteFrance
Study dates
9 Feb 2023to 11 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Foch Hospital

    Suresnes, 92150

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Acupressing, Control
Keywords
Acupressing, oocyte, women, fertility
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupressingOther

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

  • ControlOther

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

Study groups in NCT05815121
Study groupRoleWhat they receive
Acupressing groupExperimentalPatients 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
Receives: Other: Acupressing
SHAM groupSham comparatorPatients treated according to the same scheme as the experimental group, but with stickers only on the points, and the points should not be massaged.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 45 minutes after treatment

Secondary outcomes (9)

  1. 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

    Measured: between baseline to the immediate preoperative measurement

  2. 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

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

  3. 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

    Measured: up 24 hours after treatment

  4. 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

    Measured: When leaving the recovery room (up to 2 hours)

  5. Postoperative nausea and vomiting occurring

    Proportion of patients declaring postoperative nausea and vomiting occurring during the stay in the recovery room

    Measured: In the recovery room (up to 2 hours)

  6. 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

    Measured: In the recovery room (up to 2 hours)

  7. 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

    Measured: In the recovery room (up to 2 hours)

  8. 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

    Measured: In the recovery room (up to 2 hours)

  9. Quality of sleep measurement

    Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.

    Measured: up 24 hours after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start9 Feb 2023
  3. Primary completion11 Mar 2023
  4. Study completion11 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, parallel goup, single
Masking
Single blind
Who is masked
Participant
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815121
Sponsor's protocol ID
2021_0165
Acronym
ambauric
Status last verified
Apr 2025
First submitted
8 Feb 2023
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Villa G, Lanini I, Amass T, Bocciero V, Scire Calabrisotto C, Chelazzi C, Romagnoli S, De Gaudio AR, Lauro Grotto R. Effects of psychological interventions on anxiety and pain in patients undergoing major elective abdominal surgery: a systematic review. Perioper Med (Lond). 2020 Dec 8;9(1):38. doi: 10.1186/s13741-020-00169-x.

    PubMed 33292558

  • Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.

    PubMed 23245838

  • Oleson TD, Kroening RJ, Bresler DE. An experimental evaluation of auricular diagnosis: the somatotopic mapping or musculoskeletal pain at ear acupuncture points. Pain. 1980 Apr;8(2):217-229. doi: 10.1016/0304-3959(88)90009-7.

    PubMed 7402685

  • Usichenko TI, Hua K, Cummings M, Nowak A, Hahnenkamp K, Brinkhaus B, Dietzel J. Auricular stimulation for preoperative anxiety - A systematic review and meta-analysis of randomized controlled clinical trials. J Clin Anesth. 2022 Feb;76:110581. doi: 10.1016/j.jclinane.2021.110581. Epub 2021 Nov 12.

    PubMed 34781116

  • 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.

    PubMed 8504576

  • 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.

    PubMed 10768414

  • 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.

    PubMed 23304215

  • 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.

    PubMed 21148074

  • 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.

    PubMed 17499304

  • 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.

    PubMed 24848522

  • 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.

    PubMed 20529361

  • 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.

    PubMed 33996757

  • 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.

    PubMed 32430505

  • 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.

    PubMed 15166558

Questions about this trial

What is this clinical trial studying?

A study testing Acupressing in people with Fertility Disorders and Anxiety State, run by Hopital Foch at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment. (time frame: Baseline to 45 minutes after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05815121, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in