Clinical trial NCT06622850: Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics
Official title: Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Acupressure
Urodynamics
Keywords: Urodynamics
Pain
Anxiety
Acupressure
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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\&#39;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.

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\&#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: 10 months
measure: Anxiety
timeFrame: 10 months
measure: Hemodynamic Variables
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Mersin University
name: Gülay Altun Uğraş
role: PRINCIPAL_INVESTIGATOR
affiliation: MERSIN UNIVERSITY HOSPITAL
name: Elife KETTAŞ DÖLEK
role: PRINCIPAL_INVESTIGATOR
affiliation: MERSIN UNIVERSITY HOSPITAL
name: Murat BOZLU
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarsus Üniversitesi
name: Gamze Bozkul
role: STUDY_DIRECTOR
References:
citation: Safdari A, Khazaei S, Biglarkhani M, Mousavibahar SH, Borzou SR. Effect of acupressure on pain intensity and physiological indices in patients undergoing extracorporeal shock wave lithotripsy: a randomized double-blind sham-controlled clinical trial. BMC Complement Med Ther. 2024 Jan 25;24(1):55. doi: 10.1186/s12906-024-04360-1.
citation: Restawan I.G., Sjattar A.L. &amp;amp;amp; Irwan A.M. (2023). Effectiveness of acupressure therapy in lowering blood pressure in patients with hypertension: A systematic review. Clinical Epidemiology and Global Health. 21. https://doi.org/10.1016/j.cegh.2023.101292
citation: Monson E, Arney D, Benham B, Bird R, Elias E, Linden K, McCord K, Miller C, Miller T, Ritter L, Waggy D. Beyond Pills: Acupressure Impact on Self-Rated Pain and Anxiety Scores. J Altern Complement Med. 2019 May;25(5):517-521. doi: 10.1089/acm.2018.0422. Epub 2019 Mar 30.
citation: 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.
citation: 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.
citation: 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.