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

NCT ID: NCT07340645

Last Updated: 2026-02-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Embrassment Fear Urodynamics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
During the data collection process, when patients present to the urology outpatient clinic, their eligibility for inclusion in the study will be assessed by the researcher M.B. To eliminate selection bias, block randomization will be applied. Participants will be assigned to the acupressure or control group according to permutations (e.g., ABBAAB, BABABA, etc.) in a randomization list generated by an independent biostatistician using a computer-based program.

After the randomization list is created, the assignment of groups A and B to either the intervention or control group will be determined by a lottery method. Subsequently, M.B., who will not be involved in the data collection process, will prepare sealed envelopes numbered from 1 to 68 corresponding to the sample size, each containing a letter (A or B) representing the group allocation. M.B. will open the numbered envelope and inform GB of the patient's group assignment.

All researchers other than M.B. will be blinded to the gro

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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.

Control group

The control group will receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gamze BOZKUL

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gamze Bozkul

Role: STUDY_CHAIR

Tarsus University

Gülay Altun Uğraş

Role: PRINCIPAL_INVESTIGATOR

Mersin University

MURAT BOZLU

Role: PRINCIPAL_INVESTIGATOR

Mersin University

ELİFE KETTAŞ DÖLEK

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tarsus University

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gamze Bozkul

Role: CONTACT

+903246000033

Gülay ALTUN UĞRAŞ

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gamze Bozkul

Role: primary

Gülay ALTUN UĞRAŞ

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Ozturk E, Hamidi N, Yikilmaz TN, Ozcan C, Basar H. Effect of Listening to Music on Patient Anxiety and Pain Perception during Urodynamic Study: Randomized Controlled Trial. Low Urin Tract Symptoms. 2019 Jan;11(1):39-42. doi: 10.1111/luts.12191. Epub 2017 Aug 23.

Reference Type BACKGROUND
PMID: 28834330 (View on PubMed)

Kettas Dolek E, Altun Ugras G. The effect of aromatherapy during urodynamic testing on patients anxiety and cortisol levels: A randomized controlled trial. Neurourol Urodyn. 2024 Sep;43(7):1591-1599. doi: 10.1002/nau.25491. Epub 2024 May 15.

Reference Type BACKGROUND
PMID: 38747020 (View on PubMed)

Jiang ZF, Liu G, Sun XX, Zhi N, Li XM, Sun R, Zhang H. Auricular acupressure for constipation in adults: a systematic review and meta-analysis. Front Physiol. 2023 Oct 16;14:1257660. doi: 10.3389/fphys.2023.1257660. eCollection 2023.

Reference Type BACKGROUND
PMID: 37908337 (View on PubMed)

Drake MJ, Doumouchtsis SK, Hashim H, Gammie A. Fundamentals of urodynamic practice, based on International Continence Society good urodynamic practices recommendations. Neurourol Urodyn. 2018 Aug;37(S6):S50-S60. doi: 10.1002/nau.23773.

Reference Type BACKGROUND
PMID: 30614058 (View on PubMed)

Chen YW, Wang HH. The effectiveness of acupressure on relieving pain: a systematic review. Pain Manag Nurs. 2014 Jun;15(2):539-50. doi: 10.1016/j.pmn.2012.12.005. Epub 2013 Feb 15.

Reference Type BACKGROUND
PMID: 23415783 (View on PubMed)

Biardeau X, Lam O, Ba V, Campeau L, Corcos J. Prospective evaluation of anxiety, pain, and embarrassment associated with cystoscopy and urodynamic testing in clinical practice. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):104-110. doi: 10.5489/cuaj.4127.

Reference Type BACKGROUND
PMID: 28515809 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TU-BOZKUL-014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.