Effect of Acupressure on Anxiety, Embarrassment, and Procedure-Related Fear Undergoing Urodynamic

March 29, 2026 updated by: Gamze BOZKUL, Tarsus University

Effect of Acupressure on Anxiety, Embarrassment, and Procedure-Related Fear in Patients Undergoing Urodynamic Testing: A Randomized Controlled Trial

The study was planned as a randomized controlled experimental design to determine the effect of acupressure on anxiety, embarrassment, and procedure-related fear in patients undergoing urodynamic testing. Since no similar study was identified in the literature for sample size calculation, an effect size of 0.8, which is considered a large effect, was taken as a reference. With 90% power (1-α, two-tailed), the minimum required sample size was calculated using the G*Power (version 3.1) program as 68 participants, with 34 individuals in each group (intervention group = 34; control group = 34). A post hoc power analysis will also be conducted.

Data will be collected using a Sociodemographic Information Form, the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. Individuals included in the sample will be informed about the study and the procedures to be followed, and their verbal and written informed consent will be obtained. All patients will complete the Sociodemographic Information Form, the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. After the forms are completed and recorded, participants will be assigned to either the intervention or control group according to the randomization schedule.

In the intervention group, acupressure will be performed by a certified researcher (GB) who has completed acupressure training. The acupressure points to be used include Shen Men (HT7), located in the small depression between the pisiform and ulna bones on the transverse wrist crease; EX-NH3, located at the midpoint between the eyebrows on the midline of the forehead; and Hegu (LI4), located in the web space between the thumb and index finger. These points will be marked with an acetate pen by the certified researcher (GB) in patients assigned to the intervention group, and the application will be carried out by the same researcher.

No intervention will be applied to patients in the control group, and they will receive routine care only.

All patients in both the intervention and control groups will complete the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. After completion of the acupressure application, the urodynamic procedure will be performed. Immediately after the procedure, patients in both groups will again complete the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was planned as a randomized controlled experimental design to determine the effect of acupressure on anxiety, embarrassment, and procedure-related fear in patients undergoing urodynamic testing. Since no similar study was identified in the literature for sample size calculation, an effect size of 0.8, which is considered a large effect, was taken as a reference. With 90% power (1-α, two-tailed), the minimum required sample size was calculated using the G*Power (version 3.1) program as 68 participants, with 34 individuals in each group (intervention group = 34; control group = 34). A post hoc power analysis will also be conducted.

Data will be collected using a Sociodemographic Information Form, the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. Individuals included in the sample will be informed about the study and the procedures to be followed, and their verbal and written informed consent will be obtained. All patients will complete the Sociodemographic Information Form, the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. After the forms are completed and recorded, participants will be assigned to either the intervention or control group according to the randomization schedule.

In the intervention group, acupressure will be performed by a certified researcher (GB) who has completed acupressure training. The acupressure points to be used include Shen Men (HT7), located in the small depression between the pisiform and ulna bones on the transverse wrist crease; EX-NH3, located at the midpoint between the eyebrows on the midline of the forehead; and Hegu (LI4), located in the web space between the thumb and index finger. These points will be marked with an acetate pen by the certified researcher (GB) in patients assigned to the intervention group, and the application will be carried out by the same researcher.

No intervention will be applied to patients in the control group, and they will receive routine care only. Before starting the application in the intervention group, the tissue around the marked points will be gently rubbed to promote relaxation. Pressure will then be applied to the marked points using the index or middle finger, creating a depth of approximately 1-1.5 cm for 5 seconds, followed by a 2-second rest. Each point will be stimulated for 3 minutes, with the total duration of the application lasting approximately 15-20 minutes.

All patients in both the intervention and control groups will complete the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale. After completion of the acupressure application, the urodynamic procedure will be performed. Immediately after the procedure, patients in both groups will again complete the Embarrassment Assessment Scale, the State Anxiety Inventory, and the Procedure-Related Fear Scale.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Who agreed to participate in the study,
  • 18 years of age or older,
  • Conscious, oriented and cooperative,
  • No communication problems,
  • Individuals undergoing invasive urodynamic procedures.

Exclusion Criteria:

  • Who did not agree to participate in the study,
  • Under 18,
  • Conscious, oriented and uncooperative,
  • Communication problems,
  • Individuals who did not undergo invasive urodynamics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will receive routine care.
Experimental: Experimental: Acupressure group
The acupressure points to be used include Shen Men (HT7), located in the small depression between the pisiform and ulna bones at the transverse wrist crease; EX-NH3, located at the midpoint between the eyebrows on the midline of the forehead; and Hegu (LI4), located in the web space between the thumb and index finger. These points will be marked with an acetate pen on patients in the intervention group by a certified researcher (GB), and the acupressure application will also be performed by the same certified researcher (GB). Patients in the control group will not receive any intervention and will receive routine care only.
Other: Acupressure
The acupressure points to be used include Shen Men (HT7), located in the small depression between the pisiform and ulna bones at the transverse wrist crease; EX-NH3, located at the midpoint between the eyebrows on the midline of the forehead; and Hegu (LI4), located in the web space between the thumb and index finger. These points will be marked with an acetate pen on patients in the intervention group by a certified researcher (GB), and the acupressure application will also be performed by the same certified researcher (GB). Patients in the control group will not receive any intervention and will receive routine care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embrassment
Time Frame: 10 months
To assess the level of embrassment, the Visual Analog Scale (VAS) will be used. The scale allows for the subjective evaluation of embrassment on a horizontal or vertical line ranging from 0 (not afraid at all) to 10 (extremely afraid).
10 months
Anxiety
Time Frame: 11 months
The State Anxiety Scale : The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
11 months
Fear
Time Frame: 10 months
To assess the level of procedure-related fear, the Visual Analog Scale (VAS) will be used. The scale allows for the subjective evaluation of procedure-related fear on a horizontal or vertical line ranging from 0 (not afraid at all) to 10 (extremely afraid).
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Investigators

  • Principal Investigator: Gülay ALTUN UĞRAŞ, Mersin University
  • Principal Investigator: Murat Bozlu, Mersin University
  • Study Chair: Gamze Bozkul, Tarsus University
  • Principal Investigator: ELİFE KETTAŞ DÖLEK, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

March 27, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-BOZKUL-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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