Back to results

Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

Primary Purpose

Anxiety, Hemodynamic Instability

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Acupressure

Placebo acupressure

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Turkey, Mersin University,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupressure Group (experimental)

Placebo Acupressure Group (control)

Arm Description

The experimental group will be given acupressure.

The placebo group will be given placebo acupressure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic blood pressure

Systolic blood pressure (SBP), mmHg

Diastolic blood pressure

Diastolic blood pressure (DBP), mmHg

Heart rate

Beats per minute

Respiratory rate

Lung breathing

Peripheral oxygen saturation

%, percentage of oxygenated hemoglobin in peripheral arterial blood

Full Information

NCT ID

NCT05325307

First Posted

April 5, 2022

Last Updated

October 10, 2023

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT05325307

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Hemodynamic Instability

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, parallel, three-arm randomized controlled clinical trial

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupressure Group (experimental)

Arm Type

Experimental

Arm Description

The experimental group will be given acupressure.

Arm Title

Placebo Acupressure Group (control)

Arm Type

Placebo Comparator

Arm Description

The placebo group will be given placebo acupressure

Intervention Type

Other

Intervention Name(s)

Acupressure

Intervention Description

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

Intervention Name(s)

Placebo acupressure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Anxiety evaluated using the State Anxiety Scale

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Systolic blood pressure

Description

Systolic blood pressure (SBP), mmHg

Time Frame

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

Title

Diastolic blood pressure

Description

Diastolic blood pressure (DBP), mmHg

Time Frame

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

Title

Heart rate

Description

Beats per minute

Time Frame

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

Title

Respiratory rate

Description

Lung breathing

Time Frame

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

Title

Peripheral oxygen saturation

Description

%, percentage of oxygenated hemoglobin in peripheral arterial blood

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tugba CAM YANIK, PhD

Phone

+90 324 361 00 01

tugbacam@mersin.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gülay Altun Ugras, PhD

Organizational Affiliation

Mersin University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mualla Yılmaz, PhD

Organizational Affiliation

Mersin University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zeliha Yaman, PhD

Organizational Affiliation

Mersin University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Naciye Balbay, graduate

Organizational Affiliation

Mersin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turkey, Mersin University,

City

Mersin

State/Province

Turkey/Mersin,Yenişehir

ZIP/Postal Code

33343

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tuğba ÇAM YANIK, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

We'll reach out to this number within 24 hrs