Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

NCT ID: NCT05325307

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-01

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.

Conditions

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Anxiety Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, three-arm randomized controlled clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to patients. However, the researcher (Z.Y.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.

Study Groups

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Acupressure Group (experimental)

The experimental group will be given acupressure.

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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 Group (control)

The placebo group will be given placebo acupressure

Group Type PLACEBO_COMPARATOR

Placebo acupressure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Tugba CAM YANIK

PhD Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay Altun Ugras, PhD

Role: STUDY_DIRECTOR

Mersin University

Mualla Yılmaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Zeliha Yaman, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Naciye Balbay, graduate

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

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Turkey, Mersin University,

Mersin, Turkey/Mersin,Yenişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Mersin Univ

Identifier Type: -

Identifier Source: org_study_id

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