AcupressureAcupressNCT05486533
The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables
A study testing Acupressure in people with Acupressure and Pain, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupressure, Pain, Hemodynamic Instability
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2022to 30 Dec 2022
- 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 80 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,
- Over 18 years of age,
- Stable general condition,
- No sensitivity in the area where acupressure will be applied,
- No active COVID-19 infection,
- Patients without any psychiatric diagnosis will be included.
Who cannot join
- Do not agreeing to participate in the research (signing the Informed Consent Form),
- Do not conscious and cooperative,
- Do not speaks and understands Turkish,
- Do not over 18 years of age,
- Do not stable general condition,
- Having sensitivity in the area where acupressure will be applied,
- Having active COVID-19 infection,
- Patients with any psychiatric diagnosis will be included.
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: The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables Randomized Controlled Study
This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.
Read the detailed description
In the study, 124 patients will randomly assigned to acupressure/experimental group and control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. The primary outcome of the research is the effect of acupressure on the pain of patients. The secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. The pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. Data will also be collected from the control group at the same time.
- Conditions
- Acupressure, Pain, Hemodynamic Instability, Angiopathy, Peripheral
- Being tested
- Acupressure
- Medical subject headings
- Pain, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Also called Acupress
The experimental group will start with LI4 points and continue P6 and LI11 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will be given acupressure. Receives: Other: Acupressure |
| Control | No intervention | It will only take routine treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the visual analog scale
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary outcomes (5)
Systolic blood pressure
Systolic blood pressure (SBP), mmHg
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Diastolic blood pressure
Diastolic blood pressure (DBP), mmHg
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Heart rate
Beats per minute
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Respiratory rate
Lung breathing
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start25 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcupressureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 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 Uğraş, PhD, Study director, Mersin UniversityCanan KANAT, Master, Principal investigator, Mersin UniversityBarış DÜZEL, Specialist, Principal investigator, Mersin City Research and Application Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486533
- Sponsor's protocol ID
- MersinUnive
- Acronym
- Acupress
- Status last verified
- Jan 2023
- First submitted
- 1 Aug 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajaee, N., Choopani, N., Pishgoei, A. H., & Sharififar, S. (2015). The effect of acupressure on Patient's anxiety who candidate for coronary angiography. Military Caring Sciences, 1 (3), 6-13.
The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05486533
- Acronym / sponsor ID
- Acupress / MersinUnive
- Conditions
- Acupressure, Pain, Hemodynamic Instability, Angiopathy, Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 3 Aug 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 pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.
Detailed description
In the study, 124 patients will randomly assigned to acupressure/experimental group and control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. The primary outcome of the research is the effect of acupressure on the pain of patients. The secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. The pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. Data will also be collected from the control group at the same time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: AcupressureThe experimental group will be given acupressure. |
| Control | No intervention | –It will only take routine treatment and care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Agreeing to participate in the research (signing the Informed Consent Form),
- Conscious and cooperative,
- Speaks and understands Turkish,
- Over 18 years of age,
- Stable general condition,
Key exclusion criteria (8 listed)
- Do not agreeing to participate in the research (signing the Informed Consent Form),
- Do not conscious and cooperative,
- Do not speaks and understands Turkish,
- Do not over 18 years of age,
- Do not stable general condition,
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 |
|---|---|---|
| AcupressureAlso: AcupressThe experimental group will start with LI4 points and continue P6 and LI11 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 | Experimental |
Primary outcome
Pain evaluated using the visual analog scale
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.
5 secondary outcomes
Systolic blood pressure
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Diastolic blood pressure
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Heart rate
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Respiratory rate
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Peripheral oxygen saturation
Time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
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 18 Jan 2023.
- BackgroundRajaee, N., Choopani, N., Pishgoei, A. H., & Sharififar, S. (2015). The effect of acupressure on Patient's anxiety who candidate for coronary angiography. Military Caring Sciences, 1 (3), 6-13.
- Results publicationThe effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European
- 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, PhD study director
Mersin University
Canan KANAT, Master principal investigator
Mersin University
Barış DÜZEL, Specialist principal investigator
Mersin City Research and Application 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 Acupressure and Pain, 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 8 inclusion and 8 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 18 Jan 2023. 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 evaluated using the visual analog scale (time frame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation). 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 NCT05486533, which also lists 2 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 18 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.