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Clinical Trials/NCT05325307
NCT05325307
Completed
Not Applicable

Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies

Mersin University1 site in 1 country60 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Mersin University
Enrollment
60
Locations
1
Primary Endpoint
Anxiety evaluated using the State Anxiety Scale
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.

Detailed Description

In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 1, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tugba CAM YANIK

PhD Research Assistant

Mersin University

Eligibility Criteria

Inclusion Criteria

  • Agreeing to participate in the research (signing the Informed Consent Form),
  • Conscious and cooperative
  • Speaks and understands Turkish,
  • 18-65 years old,
  • Before surgery,
  • Stable general condition,
  • No sensitivity in the area where acupressure/placebo acupressure will be applied,
  • 15 July 2022 - 15 July 2023 hospitalized in the urology clinic,
  • No active COVID-19 infection,
  • Patients without any psychiatric diagnosis will be included.

Exclusion Criteria

  • Those who do not agree to participate in the research (who do not sign the Informed Consent Form)
  • Conscious and uncooperative,
  • Not speaking or understanding Turkish,
  • Not between the ages of 18-65,
  • No surgical intervention planned,
  • The planned emergency surgical intervention,
  • Unstable general condition,
  • Sensitivity in the area where acupressure/placebo acupressure will be applied,
  • Active COVID-19 infection,
  • 15 July 2022 - 15 July 2023 who did not stay in the urology clinic,

Outcomes

Primary Outcomes

Anxiety evaluated using the State Anxiety Scale

Time Frame: Change from before implementation and immediately after, 20th minute after acupressure

Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high

Secondary Outcomes

  • Respiratory rate(Change from before implementation and immediately after, 20th minute after acupressure)
  • Systolic blood pressure(Change from before implementation and immediately after, 20th minute after acupressure)
  • Diastolic blood pressure(Change from before implementation and immediately after, 20th minute after acupressure)
  • Heart rate(Change from before implementation and immediately after, 20th minute after acupressure)
  • Peripheral oxygen saturation(Change from before implementation and immediately after, 20th minute after acupressure)

Study Sites (1)

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