Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics
- Conditions
- AnxietyPainAcupressureUrodynamics
- Interventions
- Other: Acupressure
- Registration Number
- NCT06622850
- Lead Sponsor
- Tarsus University
- 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\'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\'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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupressure group 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).
- Primary Outcome Measures
Name Time Method Pain score 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).
Anxiety 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.
Hemodynamic Variables 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mersin University
🇹🇷Mersin, Turkey