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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressing | Other | Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Non-Inclusion Criteria:
Exclusion criteria
Femal with 18 years and older
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| Name | Affiliation | Role |
|---|---|---|
| Mireille MICHEL-CHERQUI, MD | Foch Hospital | Principal Investigator |
| Sabrina MA HAR, MD | Foch Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foch Hospital | Suresnes | 92150 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33292558 | Result | 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. | |
| 23245838 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Randomized, parallel goup, single
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| Control | Other | with stickers only on the points, and the points should not be massaged. |
|
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 |
| 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. |
| 7402685 | Result | 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. |
| 34781116 | Result | 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. |
| 8504576 | Result | 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. |
| 10768414 | Result | 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. |
| 23304215 | Result | 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. |
| 21148074 | Result | 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. |
| 17499304 | Result | 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. |
| 24848522 | Result | 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. |
| 20529361 | Result | 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. |
| 33996757 | Result | 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. |
| 32430505 | Result | 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. |
| 15166558 | Result | 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. |