Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119971
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-10-02
Brief Title:
Effect of Acupressure on the Yin-Tang and Shen-Men Points on Pre and Postoperative Anxiety in Elective Caesarean Section a Prospective Single-blind Randomised Controlled Trial
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Effect of Acupressure on the Yin-Tang and Shen-Men Points on Pre and Postoperative Anxiety in Elective Caesarean Section a Prospective Single-blind Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACUCESAR
Brief Summary:
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta
Detailed Description:
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta
The aim of this study is to examine the efficacy of acupressure with co-stimulation of the Yin-Tang and Shen-Men points on the reduction in pre- and postoperative anxiety in elective caesarean section
A single-blind randomised controlled single-centre study will be conducted in ASA I or II patients undergoing elective caesarean section under perispinal anaesthesia Patients will be randomised into two groups the ACU group co-stimulation of the Yin-Tang and Shen-Men points and the ACU- group stimulation of two sham points Anxiety will be assessed using the State-Trait Anxiety Inventory STAI score and by measuring skin conductance Electrodermal Activity EDA during three periods period 1 at inclusion in the patients hospital room on the morning of the procedure period 2 before arrival in the operating theatre and period 3 in the postoperative recovery room True or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3
The aim of this study is to examine the efficacy of acupressure with co-stimulation of the Yin-Tang and Shen-Men points on the reduction in pre- and postoperative anxiety in elective caesarean section
A single-blind randomised controlled single-centre study will be conducted in ASA I or II patients undergoing elective caesarean section under perispinal anaesthesia Patients will be randomised into two groups the ACU group co-stimulation of the Yin-Tang and Shen-Men points and the ACU- group stimulation of two sham points Anxiety will be assessed using the State-Trait Anxiety Inventory STAI score and by measuring skin conductance Electrodermal Activity EDA during three periods period 1 at inclusion in the patients hospital room on the morning of the procedure period 2 before arrival in the operating theatre and period 3 in the postoperative recovery room True or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None