Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Hemodynamic Instability

Intervention / Treatment
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* Other: Acupressure
* Other: Placebo acupressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, three-arm randomized controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure Group (experimental)<br>The experimental group will be given acupressure. | Other: Acupressure<br>* The experimental group will start with HT7 points and continue LI4 and EX-NH3 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.<br>|
| Placebo Comparator: Placebo Acupressure Group (control)<br>The placebo group will be given placebo acupressure | Other: Placebo acupressure<br>* In the placebo acupressure group , the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes. Less pressure will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety evaluated using the State Anxiety Scale | 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 | Change from before implementation and immediately after, 20th minute after acupressure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure (SBP), mmHg | Change from before implementation and immediately after, 20th minute after acupressure | 
| Diastolic blood pressure | Diastolic blood pressure (DBP), mmHg | Change from before implementation and immediately after, 20th minute after acupressure | 
| Heart rate | Beats per minute | Change from before implementation and immediately after, 20th minute after acupressure | 
| Respiratory rate | Lung breathing | Change from before implementation and immediately after, 20th minute after acupressure | 
| Peripheral oxygen saturation | %, percentage of oxygenated hemoglobin in peripheral arterial blood | Change from before implementation and immediately after, 20th minute after acupressure |