Clinical trial NCT05325307: Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level
Official title: Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Hemodynamic Instability
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, three-arm randomized controlled clinical trial
Primary purpose: OTHER

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.

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,
* Patients with current psychiatric diagnosis will not be included in the study.

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
measure: Diastolic blood pressure
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
measure: Heart rate
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
measure: Respiratory rate
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
measure: Peripheral oxygen saturation
timeFrame: Change from before implementation and immediately after, 20th minute after acupressure
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University,
state: Turkey/Mersin,Yenişehir
Study officials:
affiliation: Mersin University
name: Gülay Altun Ugras, PhD
role: STUDY_DIRECTOR
affiliation: Mersin University
name: Mualla Yılmaz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Zeliha Yaman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Naciye Balbay, graduate
role: PRINCIPAL_INVESTIGATOR
References: