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

T

Tarsus University

Status

Enrolling

Conditions

Fear
Urodynamics
Embrassment
Anxiety

Treatments

Other: Acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT07340645
TU-BOZKUL-014

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

Experimental: Acupressure group
Experimental group
Description:
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.
Treatment:
Other: Acupressure
Control group
No Intervention group
Description:
The control group will receive routine care.

Trial contacts and locations

1

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Central trial contact

Gamze Bozkul; Gülay ALTUN UĞRAŞ

Data sourced from clinicaltrials.gov

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