Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics

September 2, 2025 updated by: Gamze BOZKUL, Tarsus University

Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics: A Randomized Controlled Study

The study was planned as a randomized controlled experimental study to determine the effect of acupressure on pain, anxiety and hemodynamic variables in patients undergoing urodynamics. The study conducted by Azarkhavarani et al. (2024) to determine the effect of acupressure on pain in elderly female patients undergoing extracorporeal shock wave lithotripsy was used as a reference in the calculation of sample size. In the study, the effect size of the difference between pain intensity after acupressure (6.33 ± 0.54 in the experimental group and 7.36 ± 0.54 in the control group) was calculated as Cohen's d: 1,907. In order to reach a higher sample size, the minimum sample size was calculated as 34 in each group in the G*Power (3.1) program with d=0.8, (1- α, bidirectional), 90% power, taking the large effect size limit of 0.8 as a reference. Descriptive Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect the research data. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule. Acupressure will be applied to the patients in the study group by a certified researcher who has completed acupressure courses. The control group will receive routine care. After the acupressure application is completed, urodynamics will be performed. Pain, anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods will be used to evaluate the data. Parametric nonparametric tests will be used according to the suitability of the data used for normal distribution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was planned as a randomized controlled experimental study to determine the effect of acupressure on pain, anxiety and hemodynamic variables in patients undergoing urodynamics. The study conducted by Azarkhavarani et al. (2024) to determine the effect of acupressure on pain in elderly female patients undergoing extracorporeal shock wave lithotripsy was used as a reference in the calculation of sample size. In the study, the effect size of the difference between pain intensity after acupressure (6.33 ± 0.54 in the experimental group and 7.36 ± 0.54 in the control group) was calculated as Cohen's d: 1,907. In order to reach a higher sample size, the minimum sample size was calculated as 34 in each group in the G*Power (3.1) program with d=0.8, (1- α, bidirectional), 90% power, taking the large effect size limit of 0.8 as a reference. Descriptive Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect the research data. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule. Acupressure will be applied to the patients in the study group by a certified researcher who has completed acupressure courses.The points to be used in acupressure will be Shen Men (HT7) located in the transverse wrist bend, in the small depression between the pisiform and ulna bones, (LI11) located at the end of the bend when the elbow is in the bent position, and Hegu (LI4) located in the space between the thumb and index finger will be marked by the certified researcher (GB) with an acetate pen in the patients in the study group. And the application will be performed by the certified researcher (GB). Patients in the control group will not receive any application and will receive routine care. After the acupressure application is completed, urodynamics will be performed. Pain, anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods will be used to evaluate the data. Parametric nonparametric tests will be used according to the suitability of the data used for normal distribution.

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

  • Turkey (Türkiye)
    • Turkey
      • Mersin, Turkey, Turkey (Türkiye), 33400
        • Mersin University

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

Yes

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure group
In acupressure, "cun" is used as the unit of measurement to determine the points to be applied. In order to find the acupressure points correctly, measurements should be made using the individual's own fingers. The thumb widths of the individuals participating in the study will be measured and converted as centimeter 1 cun unit. The points to be used in acupressure will be Shen Men (HT7) located in the transverse wrist crease, in the small depression between the pisiform and ulna bones, (LI11) located at the end of the crease when the elbow is bent, and Hegu (LI4) located in the space between the thumb and index finger will be marked by the certified researcher (GB) with an acetate pen in the patients in the study group. And the application will be performed by the certified researcher (GB).
Other: Acupressure
In acupressure, "cun" is used as the unit of measurement to determine the points to be applied. In order to find the acupressure points correctly, measurements should be made using the individual's own fingers. The thumb widths of the individuals participating in the study will be measured and converted as centimeter 1 cun unit. The points to be used in acupressure will be Shen Men (HT7) located in the transverse wrist crease, in the small depression between the pisiform and ulna bones, (LI11) located at the end of the crease when the elbow is bent, and Hegu (LI4) located in the space between the thumb and index finger will be marked by the certified researcher (GB) with an acetate pen in the patients in the study group. And the application will be performed by the certified researcher (GB).
No Intervention: Control group
The control group will receive routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 10 months
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
10 months
Anxiety
Time Frame: 10 months
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. 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.
10 months
Hemodynamic Variables
Time Frame: 10 months
Hemodynamic Variables Monitoring Form : In this form, hemodynamic variables of the study and control groups measured before, immediately after and 15 minutes after the procedure will be recorded. Patient values will be measured and recorded by the investigator
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: Elife KETTAŞ DÖLEK, Mersin University Hospital
  • Principal Investigator: Murat BOZLU, Mersin University Hospital
  • Study Director: Gamze Bozkul, Tarsus Üniversitesi

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

Helpful Links

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)

February 15, 2024

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-BOZKUL-009

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

product manufactured in and exported from the U.S.

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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