AnxietyNCT05325307
Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level
A study testing Acupressure in people with Anxiety and Hemodynamic Instability, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Hemodynamic Instability
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the research (signing the Informed Consent Form),
- Conscious and cooperative
- Speaks and understands Turkish,
- 18-65 years old,
- Before surgery,
- Stable general condition,
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- No sensitivity in the area where acupressure/placebo acupressure will be applied,
- 15 July 2022 - 15 July 2023 hospitalized in the urology clinic,
- No active COVID-19 infection,
- Patients without any psychiatric diagnosis will be included.
Who cannot join
- Those who do not agree to participate in the research (who do not sign the Informed Consent Form)
- Conscious and uncooperative,
- Not speaking or understanding Turkish,
- Not between the ages of 18-65,
- No surgical intervention planned,
- The planned emergency surgical intervention,
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- Unstable general condition,
- Sensitivity in the area where acupressure/placebo acupressure will be applied,
- Active COVID-19 infection,
- 15 July 2022 - 15 July 2023 who did not stay in the urology clinic,
- Patients with current psychiatric diagnosis will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University,
Mersin, Turkey/Mersin,Yenişehir, 33343
About this study
Official title: Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies
This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.
Read the detailed description
In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.
- Conditions
- Anxiety, Hemodynamic Instability
- Being tested
- Acupressure, Placebo acupressure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
The experimental group will start with HT7 points and continue LI4 and EX-NH3 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.
Placebo acupressureOther
In the placebo acupressure group , the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes. Less pressure will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group (experimental) | Experimental | The experimental group will be given acupressure. Receives: Other: Acupressure |
| Placebo Acupressure Group (control) | Placebo comparator | The placebo group will be given placebo acupressure Receives: Other: Placebo acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety evaluated using the State Anxiety Scale
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Secondary outcomes (5)
Systolic blood pressure
Systolic blood pressure (SBP), mmHg
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Diastolic blood pressure
Diastolic blood pressure (DBP), mmHg
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Heart rate
Beats per minute
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Respiratory rate
Lung breathing
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: Change from before implementation and immediately after, 20th minute after acupressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Oct 2022
- Primary completion29 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Gülay Altun Ugras, PhD, Study director, Mersin UniversityMualla Yılmaz, PhD, Principal investigator, Mersin UniversityZeliha Yaman, PhD, Principal investigator, Mersin UniversityNaciye Balbay, graduate, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325307
- Sponsor's protocol ID
- Mersin Univ
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies
- ClinicalTrials.gov ID
- NCT05325307
- Acronym / sponsor ID
- Mersin Univ
- Conditions
- Anxiety, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Apr 2022 (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.
This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.
Detailed description
In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group (experimental) | Experimental | Other: AcupressureThe experimental group will be given acupressure. |
| Placebo Acupressure Group (control) | Placebo comparator | Other: Placebo acupressureThe placebo group will be given placebo acupressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agreeing to participate in the research (signing the Informed Consent Form),
- Conscious and cooperative
- Speaks and understands Turkish,
- 18-65 years old,
- Before surgery,
Key exclusion criteria (11 listed)
- Those who do not agree to participate in the research (who do not sign the Informed Consent Form)
- Conscious and uncooperative,
- Not speaking or understanding Turkish,
- Not between the ages of 18-65,
- No surgical intervention planned,
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 |
|---|---|---|
| AcupressureThe experimental group will start with HT7 points and continue LI4 and EX-NH3 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes. | Other | Acupressure Group (experimental) |
| Placebo acupressureIn the placebo acupressure group , the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes. Less pressure will be applied. | Other | Placebo Acupressure Group (control) |
Primary outcome
Anxiety evaluated using the State Anxiety Scale
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
5 secondary outcomes
Systolic blood pressure
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
Diastolic blood pressure
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
Heart rate
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
Respiratory rate
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
Peripheral oxygen saturation
Time frame: Change from before implementation and immediately after, 20th minute after acupressure
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 21 Nov 2025.
- 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 Ugras, PhD study director
Mersin University
Mualla Yılmaz, PhD principal investigator
Mersin University
Zeliha Yaman, PhD principal investigator
Mersin University
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 Hemodynamic Instability, run by Mersin 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 10 inclusion and 11 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 21 Nov 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. Some participants in this study may receive a placebo. 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?
Anxiety evaluated using the State Anxiety Scale (time frame: Change from before implementation and immediately after, 20th minute after acupressure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.