Use of Acupressing in Reproductive Medicine

Anxiety State Clinical Trial

— ambauric  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815121
• Other study ID #: 2021_0165
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: February 2, 2025

Study information

• Verified date: April 2023
• Source: Hopital Foch
• Contact: Marjolaine NGOLLO, PhD
• Phone: 01 46 25 37 49
• Email: drci-promotion[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: February 2, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Fertility Disorders

Intervention

Other:
• Acupressing
Acupuncture with placement of 4 vaccaria seeds covered with stickers on the ears and 2 on the wrists.
• Control
with stickers only on the points, and the points should not be massaged.

Locations

Country	Name	City	State
France	Foch Hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (14)

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 contr — View Citation

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. — View Citation

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.2021.66 — View Citation

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: 10.101 — View Citation

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. — View Citation

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. P — View Citation

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. — View Citation

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 y — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	before procedure to time when leaving the recovery room (up to 2 hours)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Quality of sleep measurement	Quality of sleep measured using the SPIEGEL questionnaire the day after treatment.	up 24 hours after treatment