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

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Pain Acupressure Urodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was planned as a prospective, two-arm (1:1), randomized controlled trial.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

During the data collection process, patients will be assessed for inclusion in the study by the researcher M.B. when the patients come to the urology outpatient clinic. Block randomization will be applied to eliminate selection bias. Patients will be assigned to acupressure and placebo acupressure groups according to the permutations (ABBAAB, BABABA, etc.) in the randomization list created in the computer environment by the biostatistician who is not involved in the study. After the randomization list is created, the representation of group A and B to the experimental or control group will be determined by lottery. M.B., who will not be involved in the data collection process of the study, will write numbers from 1 to 68 on the envelope as many as the number of the sample and the letter A or B representing the groups will be added inside the envelopes. M.B. will open the numbered envelope and inform GB which group the patient is in. All other researchers other than M.B. will be blinded

Study Groups

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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).

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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).

Control group

The control group will receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes