Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325307
• Other study ID #: Mersin Univ
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Mersin University
• Contact: Tugba CAM YANIK, PhD
• Phone: +90 324 361 00 01
• Email: tugbacam[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hemodynamic Instability

Intervention

Other:
• Acupressure
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.
• Placebo acupressure
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.

Locations

Country	Name	City	State
Turkey	Turkey, Mersin University,	Mersin	Turkey/Mersin,Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

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