Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

NCT05325307 | Completed

• 1 other identifier: Mersin Univ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Systolic blood pressure

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

• Diastolic blood pressure

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

• Heart rate

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

• Respiratory rate

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

• Peripheral oxygen saturation

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

Study Arms (2)

Acupressure Group (experimental)

EXPERIMENTAL

The experimental group will be given acupressure.

Other: Acupressure

Placebo Acupressure Group (control)

PLACEBO COMPARATOR

The placebo group will be given placebo acupressure

Other: Placebo acupressure

Interventions

Acupressure 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.

Acupressure Group (experimental)

Placebo acupressure 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.

Placebo Acupressure Group (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreeing to participate in the research (signing the Informed Consent Form),
• Conscious and cooperative
• Speaks and understands Turkish,
• years old,
• Before surgery,
• Stable general condition,
• No sensitivity in the area where acupressure/placebo acupressure will be applied,
• July 2022 - 15 July 2023 hospitalized in the urology clinic,
• No active COVID-19 infection,
• Patients without any psychiatric diagnosis will be included.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey/Mersin,Yenişehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gülay Altun Ugras, PhD

  Mersin University

  STUDY DIRECTOR

• Mualla Yılmaz, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

• Zeliha Yaman, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

• Naciye Balbay, graduate

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Assistant

Model Details: Prospective, parallel, three-arm randomized controlled clinical trial

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: October 1, 2022
• Primary Completion: August 29, 2024
• Study Completion: December 1, 2024
• Last Updated: November 21, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)