AnxietyNCT06622850
Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics
A study testing Acupressure in people with Anxiety and Pain, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Acupressure
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Anxiety, Pain, Acupressure, Urodynamics
- Being tested
- Acupressure
- Keywords
- Urodynamics, Pain, Anxiety, Acupressure
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | 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). Receives: Other: Acupressure |
| Control group | No intervention | The control group will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
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).
Measured: 10 months
Anxiety
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.
Measured: 10 months
Hemodynamic Variables
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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Feb 2024
- Primary completion15 May 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze BOZKUL, Tarsus University
- Investigators
- Gülay Altun Uğraş, Principal investigator, Mersin UniversityElife KETTAŞ DÖLEK, Principal investigator, MERSIN UNIVERSITY HOSPITALMurat BOZLU, Principal investigator, MERSIN UNIVERSITY HOSPITALGamze Bozkul, Study director, Tarsus Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622850
- Sponsor's protocol ID
- TU-BOZKUL-009
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38273233Restawan I.G., Sjattar A.L. & 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
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.
PubMed 30932686Jiang 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.
PubMed 37908337Drake 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.
PubMed 30614058Biardeau 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.
PubMed 28515809
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on Pain, Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06622850
- Acronym / sponsor ID
- TU-BOZKUL-009
- Conditions
- Anxiety, Pain, Acupressure, Urodynamics
- Keywords
- Urodynamics, Pain, Anxiety, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureIn 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 | No intervention | –The control group will receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Who did not agree to participate in the study,
- Under 18,
- Conscious, oriented and uncooperative,
- Communication problems,
- Individuals who did not undergo invasive urodynamics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureIn 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). | Other | Acupressure group |
Primary outcome
Pain score
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 38273233Safdari 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.
- Results publicationRestawan I.G., Sjattar A.L. & 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
- Results publication: PubMed 30932686Monson 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.
- Results publication: PubMed 37908337Jiang 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.
- Results publication: PubMed 30614058Drake 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.
- Results publication: PubMed 28515809Biardeau 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Altun Uğraş principal investigator
Mersin University
Elife KETTAŞ DÖLEK principal investigator
MERSIN UNIVERSITY HOSPITAL
Murat BOZLU principal investigator
MERSIN UNIVERSITY HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Anxiety and Pain, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622850, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.